[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-small-cell-lung-cancer":709},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,708,0,25,[9,55,78,110,146,166,192,213,234,263,295,314,381,392,419,444,466,492,521,561,580,618,646,670,688],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100053417",false,"NCT06694454","Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)","Phase I\u002FII Study of Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)","* INCLUSION CRITERIA:\n* Histologically or cytologically confirmed, resectable per standard of care stage IB-IIIA non-small cell lung cancer (NSCLC) irrespective of programmed death-ligand 1 (PD-L1) expression. Note: Confirmation is required by NCI Laboratory of Pathology (LP).\n* Willingness to undergo tumor resection surgery per standard of care (SOC) guidelines following induction therapy (platinum chemotherapy and durvalumab).\n* Participants must have disease that can be safely accessed via bronchoscopic, thoracoscopic, or percutaneous biopsy techniques, and be willing to undergo tumor biopsy before treatment.\n* No prior therapy for the NSCLC.\n* Measurable disease per RECIST 1.1\n* Age \\>= 18 years.\n* Body weight \\> 30kg.\n* ECOG Performance Status \\\u003C= 1\n* Participants must have adequate pulmonary reserve evidenced by predicted post-op FEV1 and adjusted DLCO \\>= 40% at screening.\n* Participants must have pCO2 \\\u003C= 45 and pO2 \\>=60 on room air by arterial blood gas (ABG) if O2 sat by pulse oximetry is\\\u003C= 92% on room air at screening.\n* Adequate organ and marrow function as defined below:\n\n  * Leukocytes \\>3,000\u002FmicroL\n  * Absolute neutrophil count \\>1,500\u002FmicroL (without transfusion or cytokine support)\n  * Absolute lymphocyte count \\> 800\u002FmicroL\n  * Platelets \\>100,000\u002FmicroL\n  * Hemoglobin \\>= 9.0 g\u002FdL\n  * Prothrombin time (PT) no more than 2 seconds above the upper limit of normal (ULN)\n  * Total bilirubin OR Direct bilirubin \\\u003C 1.5 X institutional upper limit of normal OR \\\u003C= ULN for participants with total bilirubin \\>= 1.5 ULN\n  * Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) \\\u003C 2.5 X institutional ULN\n  * Serum albumin \\>= 2.0 mg\u002FdL\n  * Creatinine OR Creatinine clearance (eGFR) \\\u003C= 1.6 mg\u002Fml OR \\>60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal\n* Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for the duration of the study treatment and up to 6 months after the last dose of the study drug(s). Note: participants who have cisplatin as part of SOC chemo must agree to use a highly effective method of contraception for 14 months.\n\nIndividuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 3 months after the last dose of the study drug(s). Note: participants who have cisplatin as part of SOC chemo must agree to use an effective method of contraception for 11 months. We also will recommend these individuals with partners of childbearing potential to ask partners to be on highly effective birth control (hormonal, intrauterine device (IUD), surgical sterilization).\n\n* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 3 months after the last dose of the study drug(s).\n* Participants with history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness are included if on appropriate antiretroviral therapy with HIV viral load \\\u003C400 copies\u002FmL.\n* Participants must agree to not donate blood from the study entry and up to 3 months after the last dose of the study drug(s).\n* Participants must be co-enrolled in protocol 06C0014: Prospective Evaluation of Genetic and Epigenetic Alterations in Patients with Thoracic Malignancies .\n* The ability of a participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Medically inoperable because of clinical co-morbidities.\n* Participants with T4 tumors invading the diaphragm, mediastinum, carina, trachea, esophagus, heart, great vessels, recurrent laryngeal nerve, or vertebral body.\n* Participants who experienced serious immune adverse events that required discontinuation of immune checkpoint inhibitor therapy for a prior non-NSCLC malignancy.\n* History of known EGFR or ALK alterations in the tumor.\n* History of active autoimmune disease including colitis, nephritis, hypophysitis, or neuropathy, with the exceptions of:\n\n  --Diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment.\n* History of pneumonitis or interstitial lung disease.\n* Clinically significant cardiovascular\u002Fcerebrovascular disease as follows:\n\n  * cerebral vascular accident\u002Fstroke (within 6 months prior to study treatment initiation)\n  * myocardial infarction (within 6 months prior to study treatment initiation)\n  * unstable angina, congestive heart failure (New York Heart Association Classification Class \\>= II, https:\u002F\u002Fmanual.jointcommission.org\u002Freleases\u002FTJC2016A\u002FDataElem0439.html#:\\~:text=Class%20II%20%2D%20Mild%20symptoms%20(mild,Class%20IV%20%2D%20Severe%20limitations), serious cardiac arrhythmia, clinically significant bleeding or clinically significant pulmonary embolism at screening.\n* Active Hepatitis A (HAV), Hepatitis B (HBV) (HbsAg reactive), or Hepatitis C (HCV) (HCV RNA \\[qualitative\\] is detected) at screening.\n* Other active infections requiring systemic therapy at screening.\n* Positive beta human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening.\n* Systemic corticosteroids at doses above physiologic levels (\\> 10 mg of prednisone or equivalent per day), or inhaled corticosteroids within 14 days before study treatment initiation. Administration of steroids through a route known to result in a minimal systemic exposure (i.e., topical, intro-ocular, or intra-articular) is allowed.\n* Major surgical procedure within 28 days prior to the study treatment initiation. Note: Local surgery of isolated lesions for palliative intent is acceptable provided other site(s) of disease is available for response assessment.\n* History of allogenic organ transplantation.\n* History of another primary malignancy except for malignancy treated with curative intent and with no known active disease \\>= 5 years before the study treatment initiation.\n* Administration of live attenuated vaccines within 30 days prior to study treatment initiation. Note: Administration of inactivated vaccines (e.g., inactivated influenza vaccines) is permitted before or during the study.\n* Administration of investigational drug on other clinical trial within 14 days prior to study treatment initiation.\n* History of hypersensitivity to Mannitol.\n* Herbal and natural remedies that may have immune-modulating effects within 7 days prior to study treatment initiation.\n* Uncontrolled intercurrent illness evaluated by history and physical exam or situation that would limit compliance with study requirements.","ALL","18 Years","120 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nLung cancer is the leading cause of cancer-related death worldwide. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Surgery to remove the tumors is the standard treatment for people diagnosed with early stages of NSCLC. Despite complete removal of these tumors, many recur (happen again). An FDA-approved drug combination to treat early-stage NSCLC prior to the surgery is durvalumab plus standard chemotherapy. The FDA approved infusion drug azacytidine \\[AZA\\] is used to treat several diseases because it can rapidly kill dividing cells (including cancer cells) but it is not approved for NSCLC. An inhaled (aerosolized) form of AZA is also not approved for NSCLC. However, researchers want to know if an inhaled version of AZA can help improve treatment of people with NSCLC because inhaled AZA goes directly into the lungs with limited absorption into the bloodstream.\n\nObjective:\n\nTo find the safest and most effective dose of inhaled AZA in participants with early-stage non-small cell lung cancer (NSCLC) that can still be removed by surgery.\n\nEligibility:\n\nAdults aged 18 and older with operable early-stage NSCLC. Participants will be required to also enroll in NIH protocol 06C0014 which allows for pre- and post-treatment biopsies and bloodwork to be obtained for additional research studies.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. Their medical records will be reviewed. They will have imaging scans and tests of their heart and lung functions. Participants will be required to have a tissue sample (biopsy) taken of their tumor prior to receiving study drug and again during surgery after Cycle 3; airway tissue biopsies and collection of collect bronchial (lung) fluid may also be done.\n\nParticipants will receive the study treatment for 3 cycles. Each cycle is 21 days. They will need to come to the NIH Clinical Center (CC) on days 1-4 of Cycles 1-3.\n\nAZA will be given as a drug mist that can be inhaled (like the type of mist in an asthma inhaler) using a nebulizer at the NIH Clinical Center (CC) for 3 days in a row (consecutive days) during the first week of each cycle. The participant will inhale the AZA drug mist for 20 to 30 minutes each time. Participants will also receive durvalumab and a specific 2-drug assigned chemotherapy by intravenous (IV) infusion on day 4 of each cycle.\n\nParticipants will have a follow-up visit 2 weeks after their last dose of study drugs. Then they will have planned surgery to remove the tumors.\n\nParticipants will have additional follow-up visits at the NIH CC about 1 and 3 months after the surgery, and then for every 3 months for up to 3 years.",[28,29,30,31,32],"Non-small Cell Lung Cancer (NSCLC)","Carcinoma, Non-Small Cell Lung","Non-Small Cell Lung Carcinoma","Non Small Cell Lung Cancer","Non Small Cell Lung Carcinoma",[34,35,36,37,38,39,40,41],"immune checkpoint inhibitor (CPI)","pathologic complete response (pCR)","aerosolized drug delivery","immunosuppressive tumor microenvironment (TME)","reversible epigenetic mechanisms","DNA demethylating agents","nebulizer treatment","AZA","RECRUITING","2026-07-10",{"date":45,"type":46},"2026-07-13","ACTUAL",{"date":48,"type":21},"2026-07-16",{"date":50,"type":21},"2034-12-31",{"name":52,"class":53},"National Cancer Institute (NCI)","NIH",1,{"id":56,"slug":4,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":54},"100053914","NCT07413757","CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC","A Cross-sectional Survey-based Study Using Preference Elicitation Method to Assess Decision-making Impact Factor of Chinese Patients and Physicians for First-line EGFR-TKIs Treatment of Stage IV NSCLC (CHOICE)","CHOICE","Inclusion Criteria:\n\nThe following inclusion criteria must be met in order to be enrolled in the stage 1:\n\nPatient:\n\n* Provide informed consent\n* 18 years or older\n* Diagnosed with stage IV NSCLC\n* Currently receiving or previously received 1L EGFR-TKI treatment\n* Without communication barrier\n* Do not exhibit signs of cognitive impairment that would prevent participation in an interview, as informally assessed during screening by the recruiter\n\nPhysician:\n\n* Provide informed consent\n* Specialized in departments of medical oncology, respiratory medicine, or thoracic surgery at tertiary hospitals\n* Manage at least 3 stage IV NSCLC patients with 1L EGFR-TKI per month\n* Holding the title of associate chief physician or higher\n\nThe following inclusion criteria must be met in order to be enrolled in the stage 2:\n\nPatient:\n\n* Provide informed consent\n* 18 years or older\n* Diagnosed with stage IV NSCLC\n* Currently receiving or previously received 1L EGFR-TKI treatment\n* Without communication barrier\n* Do not exhibit signs of cognitive impairment that would prevent participation in a survey, as informally assessed during screening by the recruiter\n\nPhysician:\n\n* Provide informed consent\n* Specialized in departments of medical oncology, respiratory medicine, or thoracic surgery at tertiary hospitals\n* Manage at least 3 stage IV NSCLC patients with 1L EGFR-TKI per month\n* Holding the title of attending physician or higher\n\nExclusion Criteria:\n\nNot applicable.",{"count":63,"type":21},590,"OBSERVATIONAL","This non-interventional, cross-sectional study aims to investigate treatment preferences from a sample of physicians and patients with experience of 1L EGFR-TKI for stage IV NSCLC by administering a survey, which primarily includes a DCE approach.",[67],"Non-Small Cell Lung Cancer",[69],"NSCLC;patients and physicians;survey;EGFR-TKI;patient preference;physician preference",{"date":45,"type":46},{"date":72,"type":46},"2026-03-02",{"date":74,"type":21},"2026-07-31",{"name":76,"class":77},"AstraZeneca","INDUSTRY",{"id":79,"slug":4,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100053250","NCT06765109","Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)","ALKAZAR","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)\n2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood\n3. No prior systemic anticancer treatment for NSCLC (adjuvant\u002Fneoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor \\[TKI\\] such as alectinib is not allowed in any setting)\n4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n5. Pretreatment tumor tissue\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ALK.\n2. Known allergy\u002Fhypersensitivity to excipients of neladalkib or alectinib.\n3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization\n4. Major surgery within 4 weeks prior to randomization\n5. Uncontrolled clinically relevant infection requiring systemic therapy\n6. Known active tuberculosis, or active Hepatitis B or C\n7. QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 msec on repeated assessments\n8. Clinically significant cardiovascular disease\n9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease\n10. Active malignancy requiring therapy within 2 years prior to randomization",{"count":86,"type":21},450,[88],"PHASE3","Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).",[91,92],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[94,95,96,97,98,99,100,101],"NSCLC","Lung cancer","Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":45,"type":46},{"date":104,"type":46},"2025-07-17",{"date":106,"type":21},"2029-12",{"name":108,"class":77},"Nuvalent Inc.",156,{"id":111,"slug":4,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":128,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100054097","NCT05877599","A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation","An Open-label, Phase 1, Multicentre Platform Study to Evaluate the Safety and Preliminary Anti-tumour Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Participants With Advanced Malignancies That Are Positive for the TP53 R175H Mutation","Key Inclusion Criteria (Module 1)\n\n* Subjects must be at least 18 years of age\n* Subject must be diagnosed with one of the histologies below:\n\n  * NSCLC\n  * Colorectal adenocarcinoma\n  * HNSCC\n  * Pancreatic adenocarcinoma\n  * Breast cancer\n  * Ovarian cancer\n  * Any other solid tumor\n* Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Subject has at least 1 measurable lesion\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n* Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria (Module 1)\n\n* Any another primary malignancy within the 3 years prior to enrollment\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.\n\nKey Inclusion Criteria (Module 2 - hematological malignancies)\n\n* At least 18 years of age\n* Diagnosis of AML or MDS that allows for efficacy assessments\n* Confirmation of TP53 R175H variant mutation in cancer cells\n* Subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* ECOG performance status of 0 to 1\n\nKey Exclusion Criteria (Module 2 - hematological malignancy)\n\n* Acute promyelocytic leukaemia or isolated extramedullary disease\n* Another primary malignancy within 2 years (with exceptions)\n* HSCT within 100 days or immunosuppression for GvHD within 4 weeks\n* History of CNS or other extramedullary leukaemic involvement unless a lumbar puncture is negative for leukemic cells\n* Prior stroke, ischemic attack, significant cardiac disease, heart failure\n* Prior adoptive modified cell therapy\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.",{"count":117,"type":21},45,[24],"Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies",[91,121,122,123,124,125,126,127],"Head and Neck Squamous Cell Carcinoma","Colorectal Carcinoma","Pancreatic Adenocarcinoma","Breast Cancer","Other Solid Tumors","Ovarian Cancer","Myeloid Neoplasms (AML\u002FMDS)",[129,130,131,132,133,134,135,124,126,136,137,138],"Cell therapy","TP53","Solid tumors","Non-small cell lung cancer","Head and neck squamous cell carcinoma","Colorectal carcinoma","Pancreatic adenocarcinoma","AML","MDS","TCR",{"date":45,"type":46},{"date":141,"type":46},"2023-07-12",{"date":143,"type":21},"2029-07-31",{"name":76,"class":77},18,{"id":147,"slug":4,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100053298","NCT05789082","A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation","A Phase Ib\u002FII, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation","KRAScendo 170","Inclusion Criteria:\n\n* Confirmation of Biomarker eligibility\n* Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n* Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and\u002For definitive chemoradiotherapy\n* No prior systemic treatment for advanced unresectable or metastatic NSCLC\n* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Additionally, for participants in cohort D, measurable brain metastases defined as at least 5 millimeters and twice the slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment.\n\nExclusion Criteria:\n\n* Known concomitant second oncogenic driver with available targeted treatment\n* Squamous cell histology NSCLC\n* Symptomatic, untreated, or actively progressing CNS metastases (Cohorts A, B, and C)\n* Prior treatment with a KRAS G12C inhibitor\n* Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only)\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment\n* History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more \\>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer\n* Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia\n* Co-morbid condition that is an absolute contraindication to treatment with corticosteroids\n* Inability or unwillingness to take prophylactic treatments such as corticosteroids, anti-emetics, folic acid, or vitamin B12 supplementation.\n* Participants with brain metastases for whom complete surgical resections is clinically appropriate",{"count":154,"type":21},320,[24,25],"The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).",[67],{"date":45,"type":46},{"date":160,"type":46},"2023-06-20",{"date":162,"type":21},"2032-01-29",{"name":164,"class":77},"Hoffmann-La Roche",71,{"id":167,"slug":4,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":177,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":191},"100053718","NCT07535437","A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer","A Phase 1\u002F2 Trial of Ivonescimab With Dato-DXd or Osimertinib in Patients With Metastatic EGFR-mutant Non-small Cell Lung Cancer That Progressed on EGFR TKI Therapy","Inclusion Criteria:\n\n* Written informed consent by participant\n* Biopsy-proven metastatic non-small cell lung cancer\n* Somatic activating mutation in EGFR in pre-treatment tumor biopsy or cfDNA (including all mutations with sensitivity to osimertinib) by any CLIA certified assay.\n* Prior treatment with 3rd-generation EGFR TKI therapy and platinum-based chemotherapy (or ineligible for platinum-based chemotherapy)\n* At least one measurable (RECIST 1.1) indicator lesion not previously irradiated\n* ECOG PS 0-1\n* Age ≥18 years old\n* Ability to swallow oral medications (Study Cohort B only)\n* Adequate organ function\n\n  * AST, ALT ≤ 2.5 x ULN; For patients with liver metastases, AST and ALT ≤ 5 × ULN\n  * Total bilirubin ≤ 1.5x ULN; For patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 × ULN Creatinine clearance (CrCl) ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n  * Urine protein \\\u003C 2+ or 24 hour urine protein quantification \\\u003C 1.0 g\n  * Absolute neutrophil count (ANC) ≥ 1500 cells\u002Fmm\\^3\n  * Hemoglobin ≥ 9.0 g\u002FdL (red blood cell\u002Fplasma transfusion is not allowed within 2 weeks prior to screening assessment)\n  * Platelets ≥100,000\u002Fmm3 (platelet transfusion is not allowed within 10 days prior to screening assessment)\n  * Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose.\n* Female patients of childbearing age must have negative serum pregnancy test and a negative urine pregnancy test on the day of first dose prior to dosing.\n* Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the ivonescimab and\u002For 3 months after last dose of Dato-DXd or 6 weeks after last dose of osimertinib\n* Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom plus spermicide) for the duration of the treatment period until 90 days after the last dose of ivonescimab and\u002For 6 months after the last dose of Dato-DXd or 6 weeks after last dose osimertinib. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab and\u002For 3 months after the last dose of Dato-DXd or 6 weeks after last does of osimertinib.\n\nExclusion Criteria:\n\n* EGFR exon 20 insertion positive lung cancer with expected lack of sensitivity to osimertinib (Study Cohort B only).\n* Pregnant or lactating women\n* Participation in another clinical study and receiving treatment with an investigation product during the last 4 weeks before enrollment\n* Prior exposure to anti-PD-1 inhibitor therapy\n* Prior exposure to antibody drug conjugate (ADC) containing chemotherapeutic agent targeting topoisomerase I, TROP2 antibody (Study Cohort A only).\n* History of clinically significant corneal disease (Study Cohort A only)\n* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* Major surgical procedures or serious trauma within 4 weeks of study enrollment, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior study enrollment.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks of study enrollment, including but not limited to:\n\n  * Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots). Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  * Significant nasal bleeding \u002Fepistaxis (bloody nasal discharge is allowed)\n  * Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to first study drug treatment is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.\n* Active (eg, with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n  * Short course of steroids if given for infection\n  * Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n  * Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n  * Patients with celiac disease controlled by diet alone\n* History of major diseases before first study drug treatment, specifically:\n\n  * Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to first study drug treatment, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n  * History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months of study enrollment\n  * History of any grade arterial thromboembolic event as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months before first ivonescimab infusion\n  * Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before first ivonescimab infusion\n  * History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months before first ivonescimab infusion\n* Imaging during the screening period shows that the patient has:\n\n  * Radiologically documented evidence of major blood vessel invasion (central pulmonary artery, central pulmonary veins, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava) or tumor invading organs (heart, trachea, esophagus, central bronchi \\[not including segmental bronchi\\]) or if there is a risk of esophagotracheal or esophagopleural fistula in the opinion of the investigator.\n  * Radiographic evidence of major blood vessel encasement with narrowing of the vessel or intratumor lung cavitation or necrosis that the investigator determines will pose a significantly increased risk of bleeding.\n* History of another primary malignancy except for:\n\n  * Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of study drugs and of low potential risk for recurrence\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without- evidence of disease\n  * Adequately treated carcinoma in situ without evidence of disease\n* Symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS radiation within 7 days prior to first study drug treatment, potential need for CNS radiation within the first cycle, or symptomatic leptomeningeal disease.\n\nNote: Patients must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).\n\n* Live vaccine or live attenuated vaccine within 4 weeks prior to first ivonescimab infusion, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.\n* Severe infection within 4 weeks prior to first ivonescimab infusion, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to first study drug treatment (excluding antiviral therapy for hepatitis B or C)\n* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5\n* Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic Note: Patients managed with indwelling catheters (eg, PleurX) are allowed.\n* History of interstitial lung disease (ILD) requiring steroids\n* Current use of systemic corticosteroids (\\>10 mg daily prednisone or equivalent)\n* Known history of human immunodeficiency virus (HIV) whose viral load is not controlled.\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n* Patients with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to first study drug treatment. All patients with active hepatitis C (hepatitis C virus \\[HCV\\] antibody positive with HCV RNA levels above the lower limit of detection) are excluded.\n* Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies\n* History or current evidence of any condition (medical \\[including adverse events from prior anticancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the patient to participate, in the opinion of the treating investigator.",{"count":173,"type":21},66,[24,25],"The researchers are doing this study to find out whether ivonescimab in combination with datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in people with non-small cell lung cancer (NSCLC) that has an EGFR mutation. The researchers will test different doses of the Dato-DXd or osimertinib with an unchanging (fixed) dose of ivonescimab to find the best dose that causes few or mild side effects in participants. Once the dose is found the researchers will test ivonescimab with Dato-DXd or osimertinib in a new group of participants to see if it is effective in treating their NSCLC with an EGFR mutation.",[67],[178,179,180,181,182],"Ivonescimab","Dato-DXd","Osimertinib","Metastatic EGFR-Mutant","25-366",{"date":45,"type":46},{"date":185,"type":46},"2026-04-09",{"date":187,"type":21},"2028-04",{"name":189,"class":190},"Memorial Sloan Kettering Cancer Center","OTHER",7,{"id":193,"slug":4,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100053948","NCT06077760","A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)","A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)","INTerpath-002","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.\n* Has no evidence of disease before randomization.\n* Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.\n* No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Received prior neoadjuvant therapy for their current NSCLC diagnosis.\n* Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.\n* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Active infection requiring systemic therapy.",{"count":200,"type":21},868,[88],"The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \\[N2\\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.",[91],"2026-07-09",{"date":45,"type":46},{"date":207,"type":46},"2023-12-06",{"date":209,"type":21},"2035-12-21",{"name":211,"class":77},"Merck Sharp & Dohme LLC",229,{"id":214,"slug":4,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":225,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100053529","NCT07659782","A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer","A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON\u002FOFF) Inhibitor, in Patients With Previously Treated, Advanced KRAS G12D-Mutated Non-Small Cell Lung Cancer (TARGET-D 202)","TARGET-D 202","Inclusion Criteria:\n\n* Histopathology confirmed unresectable locally advanced or metastatic NSCLC\n* Measurable disease per RECIST 1.1\n* Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)\n* ECOG PS=0 or 1\n* Adequate organ function\n* Received prior treatment with a platinum-based chemotherapy regimen and an immune checkpoint inhibitor in the advanced, non-resectable setting.\n* Have documented disease progression during or following their most recent prior line of therapy.\n\nPatients with 2L\u002F3L on stable or preferred dose:\n\n* Received at least 1 and no more than 2 prior systemic lines of therapy for advanced (in the unresectable locally advanced or metastatic setting) NSCLC.\n\nPatients with 2L-4L with brain metastases:\n\n* Received at least 1 and no more than 3 prior systemic lines of therapy for advanced (in the unresectable locally advanced or metastatic setting) NSCLC.\n* Have asymptomatic and untreated brain metastases\n* At least 1 untreated measurable brain lesion per mRECIST v1.1 with a long axis ≥ 0.5 cm and ≤ 3 cm.\n\nExclusion Criteria:\n\n* Have any other documented co-existing common RAS mutation(s)\n* Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter\n* Major surgery within 4 weeks of first treatment dose\n* Radiation therapy (RT) within 1 week of first treatment dose\n* History of drug-induced Interstitial Lung Disease\n* Receipt of prior direct RAS inhibitor\n* Untreated or symptomatic CNS metastasis\n* Receipt of strong CYP3A4 inhibitor\u002Finducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter\n* Receipt of PPI or H2 blocker within 5 days\n* Inability to swallow oral medication\n* Other protocol-defined inclusion\u002Fexclusion criteria may apply",{"count":221,"type":21},105,[25],"This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Non-Small Cell Lung Cancer",[67],"NOT_YET_RECRUITING",{"date":45,"type":46},{"date":228,"type":21},"2026-06",{"date":230,"type":21},"2028-12",{"name":232,"class":77},"Verastem, Inc.",3,{"id":235,"slug":4,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":248,"overallStatus":225,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":262},"100053828","NCT07670312","Evaluation of XYA02 in Patients With Advanced Solid Tumors","A Phase 1b\u002F2, Multicenter, Non-randomized, Open-label, Multiple Dose First- In-Human Study of XYA02 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Signed informed consent form(s) (ICFs) obtained at Screening.\n2. Has an eligible relapsed\u002Frefractory tumor with measurable disease based on RECIST 1.1 at Screening.\n3. Age ≥18 years at Screening and confirmed at the discretion of the Investigator.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at Screening.\n5. Platelet (PLT) count ≥100,000\u002FmcL at Screening.\n6. Hemoglobin ≥9.5 g\u002FdL without packed red blood cells (RBCs) transfusion within 14 days prior to Screening.\n7. Absolute neutrophil count (ANC) ≥1,500\u002FmcL at Screening.\n8. Estimated creatinine clearance (CrCl) \\>60 mL\u002Fmin at Screening. Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤3 × the upper limit of normal (ULN) at Screening.\n\n10\\. Total bilirubin ≤1.5 × ULN at Screening; in patients with a documented history of Gilbert syndrome ≤3 × ULN.\n\n11\\. At least 28 days from treatment with monoclonal antibody-based therapies at Screening.\n\n12\\. At least 5 half-lives from treatment with chemotherapy and small molecule inhibitors at Screening. 13. At least 28 days from experimental therapies not covered above at Screening.\n\n14\\. At least 28 days from radiation to more than 30% of the bone marrow or a wide field of radiation at Screening. Radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study drug is acceptable. (In case of patients treated with radiotherapy, previously irradiated lesions should not be considered a target lesion on computed tomography \\[CT\\] unless evidence of regrowth\u002Fdisease progression has been documented.) 15. At least 28 days from major surgery or significant trauma with recovery of AEs to NCI-CTCAE Grade 1 or baseline at Screening.\n\n16\\. Availability of archival tissue or, if unavailable, will be willing to undergo a tumor biopsy if a low-risk biopsy procedure is feasible at Screening. 17. Has a life expectancy of ≥ 3 months at Screening.\n\nAdditional Inclusion Criteria for Phase 1 (Dose Escalation and Backfill):\n\n18\\. Has pathologically documented advanced, relapsed, or refractory NSCLC (non-squamous), ovarian (high grade serous), gastric\u002Fesophageal\u002FGEJ adenocarcinoma, or CRC at Screening. 19. Patient must have progressed on, have relapsed after, be refractory to, or be intolerant of at least 1 prior systemic therapy, without available subsequent standard of care and have no satisfactory alternative treatment options. No more than 4 prior lines of systemic therapy for advanced, relapsed, or refractory disease in NSCLC and ovarian and no more than 3 prior lines of systemic therapy in gastric\u002Fesophageal\u002FGEJ adenocarcinoma or CRC (excluding adjuvant chemotherapy).\n\nAdditional Inclusion Criteria for Phase 2 (Dose Expansion):\n\n20\\. Cohorts for 5 different prioritized tumor types and 1 basket cohort that are advanced\u002Funresectable or metastatic at Screening according to the following criteria:\n\n1. Cohort 2A: NSCLC non-squamous. Histologically confirmed locally advanced or metastatic NSCLC (non-squamous) that have relapsed after or are refractory to platinum-doublet based chemotherapy and\u002For immune checkpoint inhibitor (in combination or sequential). Patients with EGFR or anaplastic lymphoma kinase (ALK) mutations should have been treated with appropriate targeted therapy. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy and\u002For immunotherapy).\n2. Cohort 2B: Ovarian. Histologically confirmed advanced or metastatic high-grade serous ovarian cancer that have relapsed after or are refractory to at least 1 prior line of chemotherapy and have no other satisfactory treatment options. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy or maintenance regimen).\n3. Cohort 2C: Gastric\u002Fesophageal\u002FGEJ adenocarcinoma. Histologically confirmed advanced or metastatic gastric, esophageal or GEJ adenocarcinoma that have relapsed after or are refractory to at least 1 prior line of therapy. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).\n4. Cohort 2D: CRC. Histologically confirmed advanced or metastatic CRC that have relapsed after or are refractory to at least 1 prior line of therapy. BRAF mutated patients are excluded. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).\n5. Cohort 2E: Pancreatic cancer. Histologically confirmed locally advanced or metastatic pancreatic cancer that have relapsed after or are refractory to at least 1 prior systemic treatment regimen. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).\n6. Cohort 2F: Tumor agnostic. Histologically confirmed advanced or metastatic solid tumors other than ones in Cohorts 2A to 2E that have relapsed after treatment without available subsequent standard of care. The tumor indications in this group will be selected based on data from phase 1 and preclinical data.\n\nExclusion Criteria:\n\n1. Has been refractory (did not have a tumor response) to previous treatment with a topoisomerase 1 (TOP1) inhibitor antibody-drug conjugate, at the discretion of the investigator.\n2. Has a medical history of symptomatic congestive heart failure (CHF; New York Heart Association \\[NYHA\\] classes II-IV), prior documented left ventricular ejection fraction (LVEF) \\\u003C 50%, or serious cardiac arrhythmia requiring treatment at Screening and at the discretion of the Investigator.\n3. Has a clinically significant medical history of myocardial infarction or unstable angina within 6 months before Screening at the discretion of the Investigator.\n4. Has a QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 millisecond (ms) in males and \\> 470 ms in females based on a 12-lead electrocardiogram (ECG) in triplicate performed at Screening.\n5. Has a medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or who are suspected to have these diseases by imaging at Screening at the discretion of the Investigator.\n6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals at Screening at the discretion of the Investigator.\n7. Known history of human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at Screening. If known history of hepatitis, active hepatitis B infection is defined as hepatitis B surface antigen (HbsAg) positive or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive; and active hepatitis C infection is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) positive.\n8. Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by pregnancy tests performed within 7 days before Screening.\n9. Male and female patients who are unwilling to use contraceptive methods at Screening (eg, concomitant use of a spermicidal agent and barrier contraceptive, intrauterine contraceptive during the study and for at least 7 months after the last dose of XYA02).\n10. Has clinically active brain metastases, defined as untreated and symptomatic, or requires therapy with steroids or anticonvulsants to control associated symptoms at Screening and at the discretion of the Investigator. Note: Patients with untreated asymptomatic brain metastases may be included in the study if they do not require radiotherapy treatment or surgical treatment, do not require treatment with steroids, and there are no untreated brain lesions \\> 20 mm in size.\n11. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia, lymphopenia) not yet resolved to NCI-CTCAE Grade ≤ 1 or baseline at Screening. Patients with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator (eg, peripheral neuropathy, endocrinopathies).\n12. Has a concomitant medical condition that would increase the risk of toxicity at Screening.\n13. Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product at Screening.\n14. Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer at Screening.",{"count":241,"type":21},190,[24,25],"This study will evaluate the safety, tolerability, and efficacy of XYA02 in participants with advanced solid tumors.",[245,67,126,246,247,123],"MUC1-expressing Advanced, Relapsed and\u002For Refractory Solid Tumors","GEJ Adenocarcinoma","Colorectal Cancer",[249,250,67,251,252,253,254],"MUC-1","solid tumor","Ovarian","GEJ adenocarcinoma","Colorectal","Pancreatic",{"date":45,"type":46},{"date":257,"type":21},"2026-07-15",{"date":259,"type":21},"2030-07-15",{"name":261,"class":77},"XYone Therapeutics, Inc",5,{"id":264,"slug":4,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":275,"conditions":276,"keywords":278,"overallStatus":225,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":54},"100054190","NCT07698990","Segmentectomy Versus Lobectomy for Deep Solid-Dominant Early-Stage NSCLC","Comparison of Segmentectomy and Lobectomy for Deeply Located, Solid-Dominant Early-Stage Non-Small Cell Lung Cancer (\u003C=2 cm): A Multicenter, Open-Label, Phase III, Randomized, Controlled, Non-Inferiority Clinical Trial","SOLID","Inclusion Criteria:\n\n1. Age 18 to 80 years.\n2. Solitary pulmonary nodule with maximum diameter \\\u003C=2 cm confirmed by preoperative thin-slice CT (\\\u003C=1 mm) and 3D reconstruction.\n3. Solid-dominant nodule with consolidation-to-tumor ratio (CTR) \\>0.5, including pure-solid nodules.\n4. Deeply located lesion, defined as the lesion center located in the inner two-thirds of the lung field on axial, coronal, and sagittal MPR images.\n5. Clinically definite suspected primary NSCLC after complete preoperative work-up and MDT discussion, with estimated malignancy probability \\>=95%. Preoperative pathologic confirmation is not mandatory, but preoperative or intraoperative pathology should be obtained when technically safe and feasible.\n6. Complete staging with thin-slice contrast-enhanced chest CT, whole-body PET-CT, brain contrast-enhanced MRI or CT, and serum tumor markers as appropriate; clinical stage IA (cT1a-bN0M0) without regional nodal or distant metastasis.\n7. Cardiopulmonary function sufficient to tolerate both lobectomy and segmentectomy, with FEV1 and DLCO \\>=60% predicted.\n8. Written informed consent, including special disclosure that final pathology may be benign.\n9. Centralized imaging review confirmation by the lead-center technical committee before randomization.\n\nExclusion Criteria:\n\n1. Lesion located in the right middle lobe.\n2. Lesion located in the inner two-thirds but adjacent to the lung apex or base and judged suitable for wedge resection.\n3. Two or more lesions requiring anatomic resection. One secondary lesion requiring only non-anatomic wedge resection is allowed; two main lesions in the same segment are excluded.\n4. Prior ipsilateral lung surgery or another malignancy within 5 years.\n5. Severe cardiovascular or cerebrovascular disease or other comorbidity making lobectomy or conversion to lobectomy intolerable.\n6. Planned basal segmentectomy (S7-10); proper segmentectomy is permitted.","80 Years",{"count":272,"type":21},1200,[274],"NA","SOLID is a multicenter, open-label, randomized, controlled, phase III non-inferiority trial comparing anatomic segmentectomy with lobectomy in patients with deeply located, solid-dominant, clinical stage IA non-small cell lung cancer (NSCLC) measuring \\\u003C=2 cm. Eligible participants will undergo centralized imaging review and will be randomized preoperatively in a 1:1 ratio before induction of anesthesia.\n\nThe primary endpoint is 5-year overall survival. The key supportive secondary endpoint is 5-year recurrence-free survival. The study will enroll 1,200 participants and will use intention-to-treat analysis for the primary endpoint. An independent Data and Safety Monitoring Board and an independent Endpoint Adjudication Committee will oversee safety, surgical quality, data quality, and endpoint adjudication.",[67,277],"Stage IA Non-Small Cell Lung Cancer",[279,280,281,282,283,284,285,286],"segmentectomy","lobectomy","deep pulmonary nodule","solid-dominant nodule","early-stage NSCLC","non-inferiority trial","overall survival","recurrence-free survival","2026-07-07",{"date":45,"type":46},{"date":290,"type":21},"2026-07",{"date":292,"type":21},"2034-07",{"name":294,"class":190},"Shanghai Chest Hospital",{"id":296,"slug":4,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":225,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":310,"leadSponsor":312,"locationsCount":54},"100053709","NCT07699757","HSK41959 With Standard Therapy in Solid Tumors With MTAP Deletion","Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HSK41959 Tablets in Combination With Standard Therapy in Patients With MTAP Deletion Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Adult participants aged 18 years or older.\n2. ECOG performance status of 0 to 1.\n3. Life expectancy of at least 3 months.\n4. Histologically or cytologically confirmed advanced malignant tumor with MTAP deficiency identified by a validated assay.\n5. At least one measurable lesion according to RECIST version 1.1.\n6. For NSCLC cohorts: advanced or metastatic NSCLC meeting protocol-specified disease characteristics and prior treatment requirements.\n7. For PDAC cohorts: advanced or metastatic PDAC meeting protocol-specified disease characteristics and prior treatment requirements.\n8. Adequate bone marrow, hepatic, renal, and coagulation function.\n9. Willingness to provide tumor tissue and\u002For undergo protocol-required biomarker testing, if applicable.\n\nExclusion Criteria:\n\n1. Prior exposure to agents targeting the MAT2A or PRMT5 pathway.\n2. Prior antitumor therapy or unresolved toxicities not meeting protocol-defined washout\u002Frecovery requirements.\n3. Known actionable driver alterations or prior therapies excluded by the protocol for specific NSCLC cohorts (for example EGFR, ALK, ROS1, BRAF, NTRK, MET, RET, KRAS G12C, HER2, as applicable).\n4. Significant gastrointestinal disorders that may affect drug absorption.\n5. Clinically significant cardiovascular disease, including clinically relevant QTc prolongation, reduced left ventricular ejection fraction, or severe heart failure.\n6. Uncontrolled metabolic disease, uncontrolled hypertension, or active infection.\n7. Known HIV infection, active hepatitis B with significant viral replication, or active hepatitis C infection.\n8. Use of prohibited concomitant medications, including strong inhibitors or inducers of CYP3A4, P-gp, BCRP, or other protocol-specified transporters\u002Fenzymes within the required washout period.\n9. Other serious medical or psychiatric conditions that, in the investigator's judgment, would make study participation inappropriate.",{"count":302,"type":21},258,[24],"This is a Phase Ib, open-label, multicenter study of HSK41959 tablets in combination with standard therapy in patients with MTAP-deficient advanced solid tumors. The study consists of dose-escalation and dose-expansion parts and is intended to evaluate the safety, tolerability, dose-limiting toxicity, maximum tolerated dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HSK41959 tablets when used together with standard therapy.",[67,306,307],"Pancreatic Ductal Adenocarcinoma (mPDAC)","Advanced Solid Tumors",{"date":45,"type":46},{"date":290,"type":21},{"date":311,"type":21},"2029-11",{"name":313,"class":77},"Haisco Pharmaceutical Group Co., Ltd.",{"id":315,"slug":4,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":22,"phases":322,"briefSummary":323,"conditions":324,"keywords":331,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":380},"100607241","NCT07185997","Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations","A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)","Key Eligibility Criteria:\n\n* Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.\n* Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.\n* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).\n* Patients who have received prior neo-adjuvant and\u002For adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.\n* Patients with asymptomatic CNS metastases are eligible.",{"count":321,"type":21},480,[88],"Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.",[325,326,327,328,329,330],"Non-Small-Cell Lung Cancer","Metastatic Non-Small-Cell Lung Cancer","Advanced Non-Small-Cell Lung Cancer","EGFR P-Loop and Alpha C-Helix Compressing","EGFR PACC","EGFR Uncommon Mutations",[332,333,334,335,336,337,338,339,340,94,180,341,342,343,344,345,346,347,348,96,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370],"Non-Small Cell Lung Cancer (NSCLC)","PACC","Firmonertinib","Furmonertinib","AST2818","FURMO-006","Drug-Therapy","Metastatic Non-Small Cell Lung Cancer","Advanced Non-Small Cell Lung Cancer","Afatinib","metastatic NSCLC first-line treatment","Carcinoma NSCLC","Respiratory tract neoplasms","Bronchial Neoplasms","Protein Kinase Inhibitors","tyrosine kinase inhibitor (TKI)","Alflutinib","EGFR","EGFR kinase domain mutations","EGFR activating mutation","EGFR mutation of unknown significance","Non-classical EGFR mutation","EGFR uncommon mutations","EGFR atypical mutations","G719X","S768I","E709X","E709_T710delinsD","G779F","L747X","V774M","L747P\u002FS","R776C\u002FH","G724S","E736K","I740_K745dup","N771G","K757M\u002FR","V769L\u002FM","2026-07-01",{"date":373,"type":46},"2026-07-02",{"date":375,"type":46},"2025-12-17",{"date":377,"type":21},"2030-12",{"name":379,"class":77},"ArriVent BioPharma, Inc.",78,{"id":382,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":387,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":390,"leadSponsor":391,"locationsCount":54},"100569454",{"count":20,"type":21},[24,25],"Background:\n\nLung cancer is the leading cause of cancer-related death worldwide. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Surgery to remove the tumors is the standard treatment for people diagnosed with early stages of NSCLC. Despite complete removal of these tumors, many recur (happen again). An FDA-approved drug combination to treat early-stage NSCLC prior to the surgery is durvalumab plus standard chemotherapy. The FDA approved infusion drug azacytidine \\[AZA\\] is used to treat several diseases because it can rapidly kill dividing cells (including cancer cells) but it is not approved for NSCLC. An inhaled (aerosolized) form of AZA is also not approved for NSCLC. However, researchers want to know if an inhaled version of AZA can help improve treatment of people with NSCLC because inhaled AZA goes directly into the lungs with limited absorption into the bloodstream.\n\nObjective:\n\nTo find the safest and most effective dose of inhaled AZA in participants with early-stage non-small cell lung cancer (NSCLC) that can still be removed by surgery.\n\nEligibility:\n\nAdults aged 18 and older with operable early-stage NSCLC. Participants will be required to also enroll in NIH protocol 06C0014 which allows for pre- and post-treatment biopsies and bloodwork to be obtained for additional research studies.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. Their medical records will be reviewed. They will have imaging scans and tests of their heart and lung functions. Participants will be required to have a tissue sample (biopsy) taken of their tumor prior to receiving study drug and again during surgery after Cycle 3; airway tissue biopsies and collection of collect bronchial (lung) fluid may also be done.\n\nParticipants will receive the study treatment for 3 cycles. Each cycle is 21 days. They will need to come to the NIH Clinical Center (CC) on days 1-4 of Cycles 1-3.\n\nAZA will be given as a drug mist that can be inhaled (like the type of mist in an asthma inhaler) using a nebulizer at the NIH Clinical Center (CC) for 3 days in a row (consecutive days) during the first week of each cycle. The participant will inhale the AZA drug mist for 20 to 30 minutes each time. Participants will also receive durvalumab and a specific 2-drug assigned chemotherapy by intravenous (IV) infusion on day 4 of each cycle.\n\nParticipants will have a follow-up visit 2 weeks after their last dose of study drugs. Then they will have planned surgery to remove the tumors.\n\nParticipants will have additional follow-up visits at the NIH CC about 1 and 3 months after the surgery, and then for every 3 months for up to 3 years.\n\n...",[28,29,30,31,32],[34,35,36,37,38,39,40,41],{"date":373,"type":46},{"date":287,"type":21},{"date":50,"type":21},{"name":52,"class":53},{"id":393,"slug":4,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":22,"phases":401,"briefSummary":402,"conditions":403,"keywords":408,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":54},"100317456","NCT03412877","Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer","A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in Patients With Metastatic Cancer","* INCLUSION CRITERIA:\n* Metastatic, solid cancer that can be measured, and falls into one of five cohorts: (1) gastrointestinal and genitourinary cancers; (2) breast, ovarian, and other solid cancers; (3) non-small cell lung cancer (NSCLC); (4) endocrine tumors including neuroendocrine tumors; and, (5) multiple myeloma that includes measurable solid tumors (plasmacytomas). Participants with multiple myeloma are potentially eligible only if they have measurable multiple myeloma as defined in Section 16.7 after plasmacytoma resection.\n\nNote: NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas.\n\n* Documented diagnosis of cancer.\n* Refractory to approved standard systemic therapy. Specifically:\n\n  * Participants with metastatic colorectal cancer must have received oxaliplatin or irinotecan.\n  * Participants with breast and ovarian cancer must be refractory to first- line treatment and refractory to or have refused second-line treatments.\n  * Participants with NSCLC must have received at least one platinum-based chemotherapy regimen and at least one FDA-approved targeted treatment (when appropriate).\n* Participants with endocrine tumors including neuroendocrine tumors must be refractory to first-line therapy (e.g., lanreotide, octreotide) and must be refractory or have refused second-line treatments such as everolimus, sunitinib, or 177 Lu-Dotatate, if indicated.\n* Participants with multiple myeloma must have received at least four prior lines of therapy that included at least one exposure to an immunomodulatory drug such as lenalidomide, a proteosome inhibitor, an anti-CD38 antibody treatment, and an autologous stem cell transplant.\n* Participants with three (3) or fewer brain metastases that are \\\u003C 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the participant to be eligible. Participants with surgically resected brain metastases are eligible.\n* Age greater than or equal to 18 years and less than or equal to 72 years.\n* Clinical performance status of ECOG 0 or 1.\n* Participants of both sexes must be willing to practice birth control from the time of enrollment on this study and for and 12 months after the last dose of combined chemotherapy for individuals of child-bearing potential (IOCBP) and four months after treatment for participants who can father a child.\n* Individuals of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\nNOTE: Certain malignancies may secrete hormones that produce false positive pregnancy tests. Serial blood testing (e.g. HCG measurements) and\u002F or ultrasound may be performed for clarification.\n\n* Serology:\n\n  * Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who are HIV seropositive may have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)\n  * Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then participant must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n* Hematology:\n\n  * ANC \\> 1000\u002Fmm\\^3 without the support of filgrastim\n  * WBC greater than or equal to 2500\u002Fmm\\^3\n  * Platelet count greater than or equal to 80,000\u002Fmm\\^3\n  * Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n* Chemistry:\n\n  * Serum ALT\u002FAST less than or equal to 5.0 x ULN\n  * Serum creatinine less than or equal to 1.6 mg\u002FdL.\n  * Total bilirubin less than or equal to 2.0 mg\u002FdL, except in participants with Gilbert's Syndrome, who must have a total bilirubin less than or equal to 3.0 mg\u002FdL.\n* Participants must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Participants may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to grade 1 or less. In addition, participants with multiple myeloma may receive bridging therapy during the time between study enrollment and start of study therapy. This may be necessary due to the long time needed for cell production on this study. After bridging therapy and within 14 days of protocol treatment start, participants with multiple myeloma must still have measurable multiple myeloma.\n\n* For Cohort 3: More than two weeks must have elapsed since any prior palliation for major bronchial occlusion or bleeding at the time the patient receives the preparative regimen, and patient s toxicities must have recovered to a grade 1 or less.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willing to sign a durable power of attorney.\n* Subjects must be co-enrolled on protocol 03-C-0277.\n\nEXCLUSION CRITERIA:\n\n* Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.\n* Concurrent systemic steroid therapy.\n* Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.\n* For Cohort 3: Any major bronchial occlusion or bleeding not amenable to palliation.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).\n* History of major organ autoimmune disease.\n* For Arm 2: Grade 3 or 4 major organ irAEs following treatment with anti-PD-1\u002FPD-L1, including but not limited to myocarditis and pneumonitis.\n\nNote: Participants with grade 3 or 4 major organ irAEs may be enrolled on Arm 1 if all other eligibility criteria are met.\n\n* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n* For Cohorts 1, 2, 4. or 5: Clinically significant participant history which in the judgment of the Principal Investigator (PI) would compromise the participants ability to tolerate high-dose aldesleukin.\n\nNote: At the discretion of the PI, participants enrolled in Cohort 3 may receive low-dose aldesleukin.\n\n* History of coronary revascularization or ischemic symptoms.\n* For select participants with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.\n* For select participants with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50% predicted.\n* Participants who are receiving any other investigational agents.","72 Years",{"count":400,"type":21},285,[25],"Background:\n\nA person s tumor is studied for mutations. When cells are found that can attack the mutation in a person s tumor, the genes from those cells are studied to find the parts that make the attack possible. White blood cells are then taken from the person s body, and the gene transfer occurs in a laboratory. A type of virus is used to transfer the genes that make those white blood cells able to attack the mutation in the tumor. The gene transfer therapy is the return of those white blood cells back to the person.\n\nObjective:\n\nTo see if gene transfer therapy of white blood cells can shrink tumors.\n\nEligibility:\n\nPeople with certain metastatic cancer for which standard treatments have not worked.\n\nDesign:\n\nParticipants may complete screening under another protocol. Screening includes:\n\n* Getting tumor cells from a previous procedure\n* Medical history\n* Physical exam\n* Scans\n* Blood, urine, heart, and lung tests\n\nThe study has 8 stages:\n\n1. Screening tests repeated over 1-2 weeks. Participants will have leukapheresis: Blood is removed by a needle in one arm. A machine removes white blood cells. The rest of the blood is returned by a needle in the other arm.\n2. Care at home over approximately 12 weeks.\n3. Stopping therapy for 4-6 weeks while their cells are changed in a lab.\n4. Hospital stay approximately 3-4 weeks for treatment. An IV catheter will be placed in the chest to administer drugs.\n5. Patients on Arm 2 of the study will receive the first dose of pembrolizumab while in the hospital. Three additional doses will be given after the cell infusion 3 weeks apart.\n6. Receiving changed cells by catheter. Then getting a drug over 1-5 days to help the cells live longer.\n7. Recover in the hospital for 1-2 weeks. Participants will get drugs and have blood and urine tests.\n8. Participants will take an antibiotic and maybe an antiviral for at least 6 months after treatment. They will have repeat screening tests at visits every few months for the first year, every 6 months for the second year, then as determined.",[404,67,126,124,405,406,407],"Endocrine Tumors","Gastrointestinal\u002FGenitourinary Cancers","Neuroendocrine Tumors","Multiple Myeloma",[409,410,411,412],"Gene Therapy","Immunotherapy","Cell Therapy","Adoptive Cell Therapy",{"date":373,"type":46},{"date":415,"type":46},"2018-09-06",{"date":417,"type":21},"2029-03-23",{"name":52,"class":53},{"id":420,"slug":4,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":428,"briefSummary":429,"conditions":430,"keywords":431,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":443},"100600503","NCT07098338","A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)","An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)","LIBRA","Inclusion Criteria for All Sub-studies:\n\n* Participant must be ≥ 18 years of age at the time of signing the ICF\n* WHO\u002FECOG performance status of 0 or 1\n* At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.\n* Adequate bone marrow and organ function\n* Life expectancy ≥ 12 weeks\n* Provision of acceptable tumour tissue\n\nSpecific Inclusion Criteria for Sub-Study 1 and Sub-Study 2:\n\n* Histologically or cytologically documented advanced or metastatic NSCLC\n* PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2)\n* Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs)\n\nSpecific Inclusion Criteria for Sub-Study 3:\n\n* Histologically or cytologically documented advanced or metastatic non-squamous NSCLC\n* Documented positive AGA and had progressed on prior targeted therapy\n\nExclusion Criteria for All Sub-studies:\n\n* As judged by the investigator, any severe or uncontrolled systemic diseases, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol\n* Active or prior documented autoimmune or inflammatory disorders\n* Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.\n* Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2. Unstable spinal cord compression for sub-study 3\n* Unstable brain metastases\n* History of another primary malignancy.\n* Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.\n* Uncontrolled or significant cardiac disease\n* Receipt of prior systemic chemotherapy\u002Fchemoradiation\u002Fimmunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.\n* Prior exposure to immune-mediated therapy\n* History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation\n* Any concurrent anti-cancer treatment.\n* Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention.",{"count":427,"type":21},278,[25],"This is a Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC. The study will consist of several sub-studies, each evaluating the safety, tolerability, and preliminary antitumour activity of various treatment combinations. This study will be conducted in approximately 80 centers globally across 10 countries.",[67],[432,433,434,435],"Non-Small Cell Lung Cancer(NSCLC)","Antibody-Drug Conjugates (ADCs)","T-cell immunoreceptor with Ig and Immunoreceptor Tyrosine-based Inhibition Motif (ITIM) domains (TIGIT)","Programmed death-ligand 1 (PD-L1)","2026-06-30",{"date":371,"type":46},{"date":439,"type":46},"2025-08-07",{"date":441,"type":21},"2029-04-06",{"name":76,"class":77},83,{"id":445,"slug":4,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":453,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":465},"100585189","NCT06899126","Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer","A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS \u003C50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)","DESTINY-Lung06","Inclusion Criteria:\n\n1. Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trial-specific qualification procedures.\n\n   Sign and date the Optional PGx ICF (included in the Main ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Histologically documented non-squamous locally advanced unresectable or metastatic\n\n   NSCLC and meets all of the following criteria:\n\n   Has Stage IV NSCLC disease or Stage IIIB or IIIC disease but is not a candidate for surgical resection or definitive chemoradiation at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Has no known AGAs (based on the local test results obtained using validated or approved tests as required per local regulation) that have locally available therapies targeting their AGAs in the first-line advanced\u002Fmetastatic setting.\n\n   Has no known HER2 mutation based on existing test results (if approved or validated local test is available). Note: Participants with mixed histology are eligible if non-squamous NSCLC is the predominant histology. Mixed tumors will be classified based on the predominant cell type.\n4. Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Participants who received adjuvant or neoadjuvant therapy other than those listed below, including ICI (ie, anti-PD-1\u002FPD-L1) or a platinum-based regimen, are eligible if the last dose of adjuvant\u002Fneoadjuvant therapy was given at least 6 months before the date of the first trial dose if their disease has progressed at least 6 months after the last dose date of adjuvant\u002Fneoadjuvant therapy.\n\n   1. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I.\n   2. HER2-targeted antibody-based anticancer therapy.\n5. Has adequate tumor tissue sample (not previously irradiated) available for assessment of HER2 and PD-L1 expression by central or Sponsor-specified laboratory. A new biopsy is required if the participant's most recent archival tumor tissue sample cannot be supplied.\n\nDetails pertaining to tumor tissue submission can be found in the Trial Laboratory Manual.\n\nExclusion Criteria:\n\n1. Has a medical history of MI within 6 months before randomization\u002Fenrollment or symptomatic CHF (NYHA Class II to Class IV). Participants with troponin levels above the ULN at Screening (as defined by the manufacturer) and without any MI-related symptoms must be ruled out for MI. It is highly recommended that the investigator refer such participants for a cardiologic consultation during the Screening Period.\n2. Has a QTc prolongation to \\>480 ms based on the average of the Screening triplicate 12- lead ECG.\n3. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.\n4. Has clinically severe pulmonary compromise resulting from intercurrent, pulmonary illnesses including, but not limited to:\n\n   1. Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion).\n   2. Any auto immune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis).\n\n   Severe conditions are those defined as impacting daily activities and\u002For requiring use of supplemental oxygen.\n5. Had a prior complete pneumonectomy.",{"count":452,"type":21},686,[88],"This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \\\u003C50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced\u002Fmetastatic setting.",[91],[457,94],"DESTINY",{"date":373,"type":46},{"date":460,"type":46},"2025-10-24",{"date":462,"type":21},"2032-11-24",{"name":464,"class":77},"Daiichi Sankyo",160,{"id":467,"slug":4,"hasResults":11,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":22,"phases":474,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":491},"100570828","NCT06712316","Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer","A Phase II\u002FIII, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer","Key Inclusion Criteria:\n\n* Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer\u002FAmerican Joint Committee on Cancer staging system, 9th edition.\n* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Adequate organ function.\n\nKey Exclusion Criteria:\n\n* Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic or neuroendocrine component.\n* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:\n\n  * Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neo-adjuvant\u002Fadjuvant or locally advanced\u002Fmetastatic setting.\n  * Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1\u002FVEGF bispecific antibody\n  * Have received systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\\\u003C=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.\n* Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.\n* Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation\u002Ffistula and\u002For the underlying process causing fistula\u002Fperforation.\n* Participants with significant risk of hemorrhage (per investigator clinical judgment).\n* Have superior vena cava syndrome or symptoms of spinal cord compression.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":473,"type":21},1260,[25,88],"This is a Phase 2\u002F3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).\n\nThis study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.",[91],[478,479,480,481,435,482,410,483],"First-line treatment","Combination with chemotherapy","Combination with other investigational agents","Bispecific antibody","Vascular endothelial growth factor (VEGF) A","Programmed Death-1 monoclonal antibodies",{"date":371,"type":46},{"date":486,"type":46},"2025-01-07",{"date":488,"type":21},"2030-03",{"name":490,"class":77},"BioNTech SE",261,{"id":493,"slug":4,"hasResults":11,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":22,"phases":500,"briefSummary":501,"conditions":502,"keywords":507,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":145},"100532907","NCT06218914","Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Open-label, Phase 1, Multi-Center Master Protocol to Evaluate the Safety and Preliminary Anti-Tumor Activity of TCR-engineered T Cells Recognizing KRAS Mutations in Adult Subjects With Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor\n* Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C\\*08:02 positive, HLA-A\\*11:01 or HLA-A\\*11:02 positive in at least one allele\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Presence of at least 1 measurable lesion per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n\nKey Exclusion Criteria:\n\n* Any other primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of stroke or transient ischemic attack within the 12 months prior to enrollment.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)\n* Female of childbearing potential who is lactating or breast feeding at the time of enrollment\n* Prior treatment with pan-KRAS or KRAS G12D targeting agents unless presence of KRAS G12D mutation is confirmed after the completion of treatment with pan-KRAS or KRAS G12D targeting agents.",{"count":499,"type":21},108,[24],"Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and\u002For Metastatic Solid Tumors.",[91,122,503,504,505,506],"Pancreatic Ductal Adenocarcinoma","Endometrial Cancer","Solid Tumor, Adult","KRAS G12D",[508,509,506,510,511,94,247,131,503,512,513,514],"TCR-T cell therapy","KRAS","Autologous","PDAC","HLA-C*08:02","HLA-A*11:01","HLA-A*11:02",{"date":371,"type":46},{"date":517,"type":46},"2024-03-22",{"date":519,"type":21},"2043-11-18",{"name":76,"class":77},{"id":522,"slug":4,"hasResults":11,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":11,"sex":16,"minAge":527,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":531,"conditions":532,"keywords":545,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":443},"100480603","NCT05538130","A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors","A PHASE 1A\u002FB OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS","Phase 1b Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor (excluding colorectal cancer)\n* Measurable disease by RECIST version 1.1\n* Evidence of a BRAF V600 mutation\n* Prior therapy per tumor cohort\n* Adequate organ function per protocol\n\nPhase 1b Exclusion Criteria:\n\n* Other active malignancy within 3 years\n* Presence of leptomeningeal disease\n* History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)\n* Active gastrointestinal disease as defined per protocol\n* History of interstitial lung disease as defined per protocol","16 Years",{"count":529,"type":21},124,[24],"The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).\n\nPhase 1a is no longer open for enrollment. In Phase1b (noted as \"this study\"), we are seeking participants who have:\n\n* a solid tumor which is metastatic or recurrent (excluding colorectal cancer)\n* tumor with the mutation (abnormal gene) called \"BRAF V600\"\n* received required prior treatment for cancer per cohort assigned.\n\nAll participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.\n\nParticipants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.",[533,534,535,67,536,537,538,539,540,541,542,543,544],"Melanoma","Glioma","Thyroid Cancer","Malignant Neoplasms","Brain Neoplasms","Advanced or Metastatic Solid Tumors","HGG","LGG","Low Grade Glioma","High Grade Glioma","Differentiated Thyroid Cancer","NSCLC (Non-small Cell Lung Cancer)",[546,547,548,549,550,551,552],"solid tumors","BRAF","advanced solid tumors","B-Raf","MAPK","neoplasms","BRAF V600","2026-06-29",{"date":371,"type":46},{"date":556,"type":46},"2022-11-30",{"date":558,"type":21},"2029-06-18",{"name":560,"class":77},"Pfizer",{"id":562,"slug":4,"hasResults":11,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":11,"sex":16,"minAge":527,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":22,"phases":569,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":579},"100466589","NCT05355701","A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.","A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS","This study is seeking participants who meet the following key eligibility criteria:\n\nInclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor including primary brain tumor.\n* Qualifying BRAF alteration (V600 or non-V600 Class II\u002FClass III BRAF alteration), in tumor tissue and\u002For blood (ie circulating tumor deoxyribonucleic acid \\[DNA\\], or ctDNA).\n* Disease progressed during\u002Ffollowing last prior treatment and no satisfactory alternative treatment options (Part 1, Part 2 (doublet), and Part 3 (cohorts 2, 3, 6, 7)).\n* Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies\n* Part 3 (Cohort 1) (BRAF V600 mutant melanoma): Prior BRAF V600 inhibitor therapy required, prior MEK inhibitor therapy required, and immune checkpoint inhibitor therapy required.\n* Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required. No prior BRAF inhibitor\u002FEGFR inhibitor allowed. Participants with MSI-H\u002FdMMR mCRC should receive prior immune checkpoint inhibitor therapy.\n* Part 3 (Cohort 5) (BRAF V600E CRC): No more than 2 cycles of prior 5-FU based chemotherapy allowed. No prior BRAF inhibitor\u002FEGFR inhibitors allowed. Participants with MSI-H\u002FdMMR mCRC should receive prior immune checkpoint inhibitor therapy.\n\nExclusion Criteria:\n\n* Brain metastasis larger than 4 cm\n* Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; history of retinal degenerative disease.\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK).",{"count":568,"type":21},267,[24],"The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines in people with solid tumors.\n\nThis study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called \"BRAF\" and available treatments are no longer effective in controlling their cancer.\n\nAll participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 2 times a day. Depending on the part of the study, participants may also receive another study medicine:\n\n* People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day.\n* People with colorectal cancer may also receive cetuximab or cetuximab and mFOLFOX6 (Chemotherapy regimen). Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV).\n\nParticipants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.",[533,325,535,534,572],"Advanced Colorectal Cancer (Part 1)",{"date":371,"type":46},{"date":575,"type":46},"2022-07-05",{"date":577,"type":21},"2029-10-25",{"name":560,"class":77},40,{"id":581,"slug":4,"hasResults":11,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":599,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":617},"100431255","NCT04895709","A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria\n\n* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Radiographically documented progressive disease on or after the most recent therapy.\n* Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced\u002Fmetastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.\n* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.\n\nExclusion Criteria\n\n* Women who are pregnant or breastfeeding.\n* Primary central nervous system (CNS) malignancy.\n* Untreated CNS metastases.\n* Leptomeningeal metastases.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.\n* Active, known, or suspected autoimmune disease.\n* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.\n* Prior organ or tissue allograft.\n* Uncontrolled or significant cardiovascular disease.\n* Major surgery within 4 weeks of study drug administration.\n* History of or with active interstitial lung disease or pulmonary fibrosis.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":587,"type":21},1109,[24,25],"The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.",[591,592,593,325,594,595,596,123,533,597,598],"Cervical Cancer","Gastric\u002FGastroesophageal Junction Adenocarcinoma","Microsatellite Stable Colorectal Cancer","Squamous Cell Carcinoma of Head and Neck","Carcinoma, Renal Cell","Urothelial Carcinoma","Ovarian Neoplasms","Triple Negative Breast Neoplasms",[600,591,601,602,603,592,604,593,605,606,325,94,607,594,595,596,123,533,597,598,608,609],"BMS-986340","CRC","First-in-human","GEJ","HNSCC","MSS CRC","Nivolumab","SCCHN","Docetaxel","Pumitamig",{"date":436,"type":46},{"date":612,"type":46},"2021-05-27",{"date":614,"type":21},"2031-08-31",{"name":616,"class":77},"Bristol-Myers Squibb",47,{"id":619,"slug":4,"hasResults":11,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":624,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":626,"conditions":627,"keywords":632,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":54},"100220369","NCT02146170","Tissue Procurement and Natural History Study of People With Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Extrapulmonary Small Cell Cancer, Pulmonary Neuroendocrine Tumors, and Thymic Epithelial Tumors","Tissue Procurement and Natural History Study of Patients With Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Extrapulmonary Small Cell Cancer, Pulmonary Neuroendocrine Tumors, and Thymic Epithelial Tumors","* INCLUSION CRITERIA:\n* Individuals with histologically or cytologically confirmed NSCLC, SCLC, ESCC, PNET, and TET.\n* Individuals consulted in the Clinical Center without a definitive diagnosis, but clinically considered likely to have a malignancy of the above histologies, pending further tissue acquisition and\u002For pathology review.\n* Age greater than or equal to18 years. Children are excluded from the study, as the above thoracic malignancies are rare in this population.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.\n* Active concomitant medical or psychological illnesses that may increase the risk to the subject, at the discretion of the Principal Investigator.\n* Known HIV-positive individuals not on combination antiretroviral therapy are ineligible.",{"count":625,"type":21},2000,"Background:\n\n\\- Lung cancer is the leading cause of cancer-related death worldwide. It causes more than one million deaths every year. Researchers want to gather tissue samples from people with lung and thymic cancers to understand the disease better. This may lead to new ways to diagnose and treat it.\n\nObjective:\n\n\\- To collect tissue samples for use in the study of lung cancers.\n\nEligibility:\n\n\\- Adults over age 18 with non-small cell lung cancer, small cell lung cancer, extra pulmonary small cell cancer, pulmonary neuroendocrine tumors, and thymic epithelial tumors.\n\nDesign:\n\n* Participants will be screened with a medical history, physical exam, and blood tests. They will be asked about how they perform their daily tasks.\n* Participants may be asked to give urine and blood samples. They may give a saliva sample if they cannot give blood. They will also give a sample of their tumor from a biopsy they had. They may also be given the option to undergo a biopsy.\n* Participants may have MRI, CT, and\u002For PET scans of the body. They will lie in a machine that takes pictures of the body.\n* After visits to the Clinical Center end, researchers will contact participants by phone every year to check on their health.",[67,628,629,630,631],"Small Cell Lung Cancer","Extrapulmonary Small Cell Cancer","Pulmonary Neuroendocrine Tumors","Thymic Epithelial Tumors",[633,634,635,636,637,638],"Sample Acquisition","Genetic and Epigenetic Alterations","Mig6 Expression","Proteomic Analysis","Genomic Analysis","Natural History","2026-06-27",{"date":436,"type":46},{"date":642,"type":46},"2014-05-28",{"date":644,"type":21},"2029-12-31",{"name":52,"class":53},{"id":647,"slug":4,"hasResults":11,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":4,"eligibilityCriteria":651,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":652,"targetDuration":4,"studyType":22,"phases":654,"briefSummary":655,"conditions":656,"keywords":657,"overallStatus":225,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":669},"100645337","NCT07680790","Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)","A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB\u002FIIIC), metastatic (Stage IVA\u002FIVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment\n* Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)\n* Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator\n* Participants must have ECOG Performance Status 0-1\n\nExclusion Criteria:\n\n* Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and\u002For spinal cord compression\n* Participants must not have history of ILD\u002Fpneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD\u002Fpneumonitis\n* Participants must not have clinically significant cardiac disease\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":653,"type":21},850,[88],"The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy",[67],[94,349,658,659,180,660,661],"First line","Izalontamab brengitecan","ADC","IZABRIGHT-Lung02","2026-06-26",{"date":373,"type":46},{"date":665,"type":21},"2026-09-30",{"date":667,"type":21},"2031-12-30",{"name":616,"class":77},180,{"id":671,"slug":4,"hasResults":11,"nctId":672,"briefTitle":673,"officialTitle":674,"acronym":4,"eligibilityCriteria":675,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":676,"targetDuration":4,"studyType":22,"phases":678,"briefSummary":679,"conditions":680,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":681,"startDateStruct":682,"completionDateStruct":684,"leadSponsor":686,"locationsCount":687},"100548526","NCT06422143","Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]","Phase 3 Study of Pembrolizumab in Combination With Carboplatin\u002FTaxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) \\[Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8\\]\n* Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator\u002Fradiology\n* Has life expectancy ≥3 months\n* Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation\n* Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg)-positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible)\n* Has adequate organ function\n* For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12 or most recent scan before randomization\n* For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit\n* For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade ≤2 fatigue, Grade ≤2 peripheral neuropathy, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered\n* For Maintenance only (prior to randomization): has not experienced a pneumonitis\u002Finterstitial lung disease (ILD) event during the study-specified induction\n\nExclusion Criteria:\n\n* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n* History of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention\n* HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and\u002For radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC\n* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T lymphocyte-associated protein 4, OX-40, CD137). Note: Prior treatment with an anti-PD-1 or anti-PD-L1 agent for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC\n* Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antidrug conjugate (ADC)\n* Received radiation therapy to the lung that is \\>30 Gray within 6 months of start of study intervention\n* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications\n* Received prior treatment with a topoisomerase I inhibitor-containing ADC\n* Is currently receiving a strong inducer\u002Finhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks)\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has known central nervous system (CNS) metastases\u002Fcarcinomatous meningitis\n* Severe hypersensitivity (≥Grade 3) to study intervention and\u002For any of its excipients or to another biologic therapy\n* Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy \\[eg, thyroxine, insulin, or physiologic corticosteroid\\] is allowed)\n* Has a history of (noninfectious)pneumonitis\u002FILD that required steroids, has current pneumonitis\u002FILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening\n* Active infection requiring systemic therapy\n* History of allogeneic tissue\u002Fsolid organ transplant",{"count":677,"type":21},851,[88],"This is a phase 3 study of pembrolizumab in combination with carboplatin\u002Ftaxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).",[91,94],{"date":553,"type":46},{"date":683,"type":46},"2024-06-10",{"date":685,"type":21},"2031-02-12",{"name":211,"class":77},212,{"id":689,"slug":4,"hasResults":11,"nctId":690,"briefTitle":691,"officialTitle":692,"acronym":693,"eligibilityCriteria":694,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":695,"targetDuration":4,"studyType":22,"phases":697,"briefSummary":698,"conditions":699,"keywords":700,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":702,"startDateStruct":703,"completionDateStruct":705,"leadSponsor":707,"locationsCount":708},"100540076","NCT06312137","A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)","A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery","TroFuse-019","The key inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement \\[N2\\]) per AJCC eighth edition guidelines\n* Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy\n* Is able to undergo surgery based on opinion of investigator after consultation with surgeon\n* Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy\n* Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology.\n* Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period\n* Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest\u002Fabdomen\u002Fpelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization\n* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load at screening\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention\n\nExclusion Criteria:\n\n* Has one of the following tumor locations\u002Ftypes:\n\n  * NSCLC involving the superior sulcus\n  * Large cell neuro-endocrine cancer (LCNEC)\n  * Sarcomatoid tumor\n  * Diagnosis of SCLC or, for mixed tumors, presence of small cell elements\n* Has Grade ≥2 peripheral neuropathy\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to \\>480 ms, and\u002For other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention\n* Has received prior neoadjuvant therapy for their current NSCLC diagnosis\n* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication\n* Has a known additional malignancy that is progressing or has required active treatment within the past 5 years\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years\n* Has a history of (noninfectious) interstitial lung disease (ILD)\u002Fpneumonitis, has current ILD\u002Fpneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening\n* Has an active infection requiring systemic therapy\n* Is an HIV-infected participant with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has a concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection\n* Has a history of allogeneic tissue\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or have ongoing surgical complications\n* Severe hypersensitivity (≥Grade 3) to study intervention, any of its excipients, and\u002For to another biologic therapy",{"count":696,"type":21},780,[88],"This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).",[31],[701,95,132],"Carcinoma",{"date":553,"type":46},{"date":704,"type":46},"2024-04-03",{"date":706,"type":21},"2034-10-23",{"name":211,"class":77},266,""]