[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lung-cancer-non-small-cell-cancer-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lung-cancer-non-small-cell-cancer-nsclc":188},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,79,112,141,165],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100643728",false,"NCT07637448","EGFR-TKIs Plus PD-1 in EGFR-Mutant Advanced NSCLC","A Clinical Study Evaluating the Preliminary Antitumor Activity and Safety of EGFR-TKIs Combined With PD-1 Monoclonal Antibody as First-Line Therapy in Patients With EGFR-Mutant Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Patients with histologically or cytologically confirmed, previously untreated EGFR-mutant (19del\u002FL858R) locally advanced or metastatic (stage IIIB\u002FIIIC or IV) non-small cell lung cancer (NSCLC), according to the 9th edition of the TNM staging system for lung cancer jointly issued by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC);\n2. Male or female patients aged ≥ 18 years;\n3. Patients who are willing to receive third-generation EGFR-TKI targeted therapy, followed by maintenance therapy with a PD-1 antibody during the stable phase of the disease (defined as no further tumor shrinkage for at least two consecutive assessments based on RECIST v1.1 criteria);\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n5. At least one measurable or non-measurable but evaluable lesion according to RECIST version 1.1;\n6. Adequate organ function;\n7. Female or male patients of childbearing potential must agree to use highly effective contraceptive measures throughout the study period;\n8. Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements as specified in the visit schedule.\n\nExclusion Criteria:\n\n1. Patients who are ineligible for standard anti-tumor therapy according to routine clinical practice;\n2. Prior treatment with anti-PD-1\u002FPD-L1 immunotherapy;\n3. Concurrent enrollment in another clinical study;\n4. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n5. Receipt of systemic corticosteroids or other immunosuppressive therapy within 2 weeks prior to the first dose of study drug;\n6. Receipt of any live vaccine within 4 weeks prior to the first dose of study drug, or planned receipt of live vaccine during the study period;\n7. Presence of brainstem, leptomeningeal, spinal cord metastasis, or spinal cord compression;\n8. Presence of uncontrolled concomitant diseases, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, etc.;\n9. History of severe gastrointestinal ulcer, gastrointestinal perforation, fistula or obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose, or other gastrointestinal diseases that, in the investigator's opinion, may predispose to bleeding or perforation;\n10. Presence of severe uncontrolled cardiovascular disease;\n11. Interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis) requiring corticosteroid therapy, or current ILD\u002Fnon-infectious pneumonitis;\n12. Concomitant pulmonary disease resulting in clinically severe impairment of respiratory function;\n13. Chronic autoimmune disease or inflammatory disease requiring systemic therapy or receiving systemic therapy within 2 years prior to the first dose;\n14. Active or history of documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea), intestinal obstruction, or extensive bowel resection;\n15. Diagnosis of Gilbert's syndrome;\n16. Severe infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;\n17. Known active pulmonary tuberculosis;\n18. Known active syphilis infection;\n19. Known history of immunodeficiency, or positive test for human immunodeficiency virus (HIV) antibody;\n20. Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;\n21. Known allergy to any component of any study drug, history of severe allergic reactions (e.g., anaphylactic shock), history of severe hypersensitivity to other monoclonal antibodies or recombinant protein-based substances, or history of severe infusion reactions;\n22. Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study period;\n23. Any disease, medical condition, organ system dysfunction, or social circumstance (including but not limited to psychiatric illness, substance\u002Falcohol abuse, history of drug abuse, etc.) that, in the investigator's opinion, may interfere with the subject's ability to provide informed consent, adversely affect the subject's cooperation and participation in the study, or confound the interpretation of study results.","ALL","18 Years",{"count":18,"type":19},32,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This study is an open-label, multicenter, single-arm clinical study.",[25,26,27],"Lung Cancer Non-Small Cell Cancer (NSCLC)","EGFR Activating Mutation","PD-1 Antibody",[29,30,31,32],"Non-Small Cell Cancer (NSCLC)","EGFR-Mutant","EGFR-TKIs","PD-1 Monoclonal Antibody","RECRUITING","2026-06-04",{"date":36,"type":37},"2026-06-09","ACTUAL",{"date":39,"type":37},"2026-05-21",{"date":41,"type":19},"2030-03-01",{"name":43,"class":44},"Nanfang Hospital, Southern Medical University","OTHER",1,{"id":47,"slug":4,"hasResults":10,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":45},"100635138","NCT07548788","A Lay Navigation Intervention for Patients With Lung Cancer","Feasibility and Acceptability of the Care and Connect Program for Patients With Lung Cancer","Inclusion Criteria:\n\n* Patient with diagnosis of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) of any stage\n* Age ≥ 18\n* Have completed their first medical appointment at the Medical Oncology Lung Cancer Clinic at Princess Margaret Cancer Centre (PM), University Health Network\n* Cognitive capacity to consent and complete questionnaires\n\nExclusion Criteria:\n\n* Behavioural safety alert on medical record that would make their participation in Care \\& Connect inappropriate\n* Enrolment in another navigation study within University Health Network\n* Patients who come to PM for a clinical trial visit\n* Inability to communicate and read in English",{"count":53,"type":19},50,[55],"NA","Background: In Canada, lung cancer accounts for approximately 25% of cancer deaths each year. There are also known sociodemographic and racial inequities in the diagnosis and treatment of lung cancer. Studies have consistently found that patients with cancer have a high number of unmet needs, including psychological, physical, and informational. Navigation programs represent a potentially promising, equitable, and cost-effective approach to address the unmet needs of patients with lung cancer, but there is limited evidence about their effectiveness in patients with lung cancer. The investigators developed and have implemented a volunteer lay navigator program, Care and Connect (C\\&C), which aims to proactively reduce distress in patients, provide information and support, and increase access to treatment and supportive care resources. The proposed pilot randomized controlled trial (RCT) project plans to 1) assess the feasibility and acceptability of referral to C\\&C and, 2) examine the preliminary effectiveness of C\\&C.\n\nMethods: The current study is a 2-arm, parallel group, mixed methods, pilot RCT with a 1:1 allocation ratio and 3 timepoints: baseline (T0), 3 months (T1), 6 months (T2). It is designed to test the trial feasibility and acceptability of the C\\&C intervention in patients with lung cancer. In total, 50 participants will be randomized to receive the C\\&C intervention or usual care only (25 per arm). At each timepoint, data will be collected on participants' access to psychosocial (PSO) services, psychological wellbeing, and satisfaction with care through participant medical record and a survey. To gain additional insights regarding the acceptability, feasibility, and impact of C\\&C, a subset of 15 participants from the intervention group will be contacted for qualitative exit interviews.\n\nExpected outcomes: There is limited evidence about the effects of lay navigation programs on access to PSO services among patients with lung cancer. This work addresses this knowledge gap by evaluating the feasibility, acceptability, and preliminary impact of C\\&C on patients with lung cancer. The findings of the proposed work will expand the body of evidence supporting lay navigation to the lung cancer population, contributing to the evidence base for patient-centred care.",[25,58,59],"Lung Cancer Small Cell Lung Cancer (SCLC)","Patient Navigation",[61,62,63,64,65,66,67,68],"Lay navigation","Lung cancer","Access to care","Patient navigation","Feasibility","RCT","Pilot","Acceptability","NOT_YET_RECRUITING","2026-04-21",{"date":72,"type":37},"2026-04-23",{"date":74,"type":19},"2026-04-01",{"date":76,"type":19},"2027-12-01",{"name":78,"class":44},"University Health Network, Toronto",{"id":80,"slug":4,"hasResults":10,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":20,"phases":87,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100624096","NCT07405190","Ivonescimab Alone And With Carboplatin\u002FPemetrexed For NSCLC","A Phase II Study of Ivonescimab as Monotherapy or in Combination With Platinum\u002FPemetrexed Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring Actionable Genomic Alterations (AGAs)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC not amenable to curative resection or radiation.\n* AGA requirements as follows:\n\nIvonescimab monotherapy: Tumor harboring classical EGFR sensitizing mutation (i.e., L858R, exon 19 deletion), or ALK, ROS1, RET, or NTRK1-3 fusion, per local testing. Note: The number of patients with EGFR mutation-positive NSCLC enrolled will be capped at maximum of 10 (in order to ensure the assessment of non-EGFR disease subsets). Ivonescimab plus carboplatin\u002Fpemetrexed: Tumor harboring ALK, ROS1, RET, or NTRK1-3 fusion, per local testing.\n\n* Prior therapy requirements as follows:\n\n  a. Prior genotype-specific standard-of-care targeted therapy must have included at least one genotype-appropriate TKI(s) specified below: i. EGFR sensitizing mutation: a third-generation EGFR TKI such as osimertinib or lazertinib ii. ALK fusion: a third- or fourth-generation ALK TKI such as lorlatinib or neladalkib (NVL-655) iii. ROS1 fusion: crizotinib, entrectinib, repotrectinib, or taletrectinib iv. RET fusion: selpercatinib or pralsetinib v. NTRK1-3 fusion: entrectinib, larotrectinib, or repotrectinib Ivonescimab monotherapy: Must have received platinum\u002Fpemetrexed chemotherapy. No limitations on the number of prior lines of systemic therapy including the number of lines of chemotherapy or TKI(s). Ivonescimab plus carboplatin\u002Fpemetrexed: May not have received any prior chemotherapy. No limitations on the number of prior TKI(s).\n* At least 1 measurable lesion as assessed by investigator per the RECIST v1.1 criteria for both cohorts.\n* Participants must be willing to undergo the mandatory pre-treatment and post-progression tissue biopsies. If archival pre-treatment tissue is available from within 6 months of study enrollment, with no new intervening systemic therapy since the biopsy, a repeat pre-treatment biopsy may be omitted upon discussion with the principal investigator. On-treatment tissue biopsy (obtained within 7 days prior to Cycle 2 Day 1) will be mandatory for patients in Cohort 1 and optional for patients in Cohort 2. In select cases, if medically deemed unsafe\u002Fnot feasible, exception may be granted upon discussion with the principal investigator.\n* Clinically asymptomatic treated or untreated brain metastases are allowed if they have not required increasing doses of steroids within 2 weeks prior to study entry for CNS symptoms.\n* Age ≥18 years old.\n* ECOG performance status of 0 or 1.\n* Adequate Organ Function:\n\n  a. Hematology (no blood transfusions or growth factor therapy used within 7 days of the screening CBC): i. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL ii. Platelet count ≥ 100 × 109\u002FL iii. Hemoglobin ≥ 9.0 g\u002FdL b. Kidneys: i. Creatinine clearance (CrCl) ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula (Cohorts 1 and 2) or estimated glomerular filtration rate (eGFR) value ≥ 60 mL\u002Fmin (for Cohort 1) or ≥30 mL\u002Fmin (for Cohort 2) using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) ii. Urine protein \\\u003C 2+ or 24 hour urine protein quantification \\\u003C 1.0 g c. Liver: i. Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 × ULN ii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\n  * 2.5 × ULN; for patients with liver metastases, AST and ALT ≤ 5 × ULN d. Coagulation: prothrombin time (PT) or international normalized ratio (INR)\n  * 1.5 x 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 for at least one month prior to study enrollment.\n* Female patients of childbearing age must have negative serum pregnancy test results before first ivonescimab drug dose or per region-specific guidance documented in the informed consent 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 until 6 months after the last doses of carboplatin and pemetrexed.\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) for the duration of the treatment period until 90 days after the last dose of ivonescimab and until 90 days after the last doses of carboplatin and pemetrexed. 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 until 90 days after the last doses of carboplatin and pemetrexed.\n\nExclusion Criteria:\n\n* Participants previously treated with immune checkpoint inhibitors or other T cell immune-modulating antibodies, including anti-CTLA-4, anti-PD-1 and\u002For anti-PD-L1 agents.\n* Major surgical procedures or serious trauma within 4 weeks prior to first ivonescimab dose or plans for major surgical procedures within 4 weeks after the first ivonescimab dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to first ivonescimab dose.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to first ivonescimab dose, including but not limited to:\n\n  1. 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  2. Nasal bleeding\u002Fepistaxis (bloody nasal discharge is allowed)\n  3. Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to first ivonescimab dose is not allowed; stability of anti-coagulation dosing will be defined by remaining on the same dose for at least one month prior to study enrollment.\n  4. 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* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.\n* Active autoimmune or lung disease requiring systemic therapy (eg, with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to first ivonescimab dose; however, the following will be allowed:\n\n  1. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n  2. Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted.\n* History of major diseases before first ivonescimab dose, specifically:\n\n  1. 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 6 months prior to first ivonescimab dose, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n  2. History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before first ivonescimab dose\n  3. History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 6.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to first ivonescimab dose\n  4. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before first ivonescimab dose\n  5. 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 prior to first ivonescimab dose\n* Imaging during the screening period shows that the patient has:\n\n  1. 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  2. 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* Symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to first ivonescimab dose, potential need for CNS radiation within the first cycle, or 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 planned first ivonescimab dose, 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 dose, 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 ivonescimab dose (excluding antiviral therapy for hepatitis B or C)\n* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 6\n* Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic Note: Patients managed with indwelling catheters (eg, PleurX) are allowed.\n* Any evidence of current ILD or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring systemic corticosteroids\n* Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Known history of human immunodeficiency virus (HIV) whose viral load is not controlled.\n* Current use of systemic corticosteroids (\\>10 mg daily prednisone or equivalent)\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 ivonescimab dose. 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\n* Patient is breastfeeding or plans to breastfeed during the study",{"count":86,"type":19},46,[22],"The goal of this clinical trial is to assess the efficacy of ivonescimab monotherapy in patients with advanced non-small cell lung cancer harboring actionable genomic alterations who have received prior targeted therapies and chemotherapy. This clinical trial also aims to assess the efficacy of ivonescimab plus carboplatin\u002Fpemetrexed chemotherapy in patients with advanced non-small cell lung cancer harboring actionable genomic alterations other than epidermal growth factor receptor mutations who have received prior targeted therapies but no chemotherapy. The main questions it aims to answer are:\n\n* Will ivonescimab alone or together with carboplatin\u002Fpemetrexed chemotherapy shrink tumors in the clinical trial's patients?\n* Will ivonescimab alone or together with carboplatin\u002Fpemetrexed chemotherapy effectively influence if the patients' cancer grows, how long the treatment takes to start working, how long the treatment keeps working after it first starts to help, how long the treatment keeps the cancer from getting worse, and overall survival of patients?\n* How many patients receiving ivonescimab alone or together with carboplatin\u002Fpemetrexed chemotherapy will experience treatment-emergent, treatment-related, immune-related, and especially interesting side effects? Patients receiving ivonescimab alone will receive an intravenous infusion of ivonescimab every 3 weeks for up to 24 months. Patients receiving ivonescimab together with carboplatin\u002Fpemetrexed chemotherapy will receive separate intravenous infusions of ivonescimab, pemetrexed, and carboplatin every 3 weeks for 4 cycles (each cycle is 21 days). These patients will continue to receive infusions of ivonescimab and pemetrexed every 3 weeks for up to 24 total months.",[90,25,91,92,93,94],"Lung Cancer (NSCLC)","Lung Cancer (Non-Small Cell)","Lung Cancer - Non Small Cell","Lung Cancer Non Small Cell","Genomic Alterations",[96,97,98,99,100,101],"NSCLC","AGAs","lung cancer","non-small cell","chemotherapy","ivonescimab","2026-02-05",{"date":104,"type":37},"2026-02-12",{"date":106,"type":19},"2026-08-04",{"date":108,"type":19},"2029-03-01",{"name":110,"class":44},"Massachusetts General Hospital",3,{"id":113,"slug":4,"hasResults":10,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":20,"phases":122,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100578385","NCT06810609","Immunochemotherapy, Surgery or Chemoradiation, and Durvalumab for Stage IIIA\u002FB NSCLC","Prospective Randomized Phase II Trial on Induction Immunochemotherapy Followed by Surgery or Definitive Chemoradiation and Consolidation Durvalumab (MEDI4736) in Resectable and Borderline Resectable Stage IIIA\u002FB NSCLC","InDuRanS","Inclusion Criteria:\n\n1\\. Patient is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (European Union \\[EU\\] Data Privacy Directive in the EU) obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n\n2\\. Patient is willing and able to comply with the protocol for the duration of the study 3. Age ≥ 18 years and \\\u003C 75 years. 4. All sex and gender. 5. Female patients of childbearing potential as well as male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to the Clinical Trials Facilitation and Coordination Group (CTFG) during the course of this study and for at least 90 days after the last dose of durvalumab or 6 months after the last dose of chemotherapy, whichever occurs last.\n\n6\\. Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause.\n\n7\\. Histologically and \u002F or cytologically proven NSCLC (EGFRm-, ALK-). 8.\n\nSelected patients with NSCLC stage IIIA\u002FB:\n\n1. IIIA: one or more lymph node levels involved at EBUS\u002Fmediastinoscopy T1\u002FT2 N2.\n2. IIIB: one or more lymph node levels involved at EBUS\u002Fmediastinoscopy T3\u002FT4 N2. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 10. Given technical\u002Foncologic complete resectability (R0) at the time of inclusion. 11. Sufficient functional reserves for the planned surgery 12. Fulfilment of adequate criteria for functional and medical resectability as described in the European Respiratory Society (ERS)\u002F European Society of Thoracic Surgeons (ESTS) guidelines (Brunelli et al. 2009) and acceptable general clinical condition for multimodality treatment (interdisciplinary committee).\n\n   13\\. Life expectancy of \\> 12 weeks. 14. Body weight \\> 30 kg. 15.\n\n   Adequate normal organ and bone marrow function as defined below:\n\na. Hemoglobin ≥ 9.0 g\u002FdL. b. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL. c. Platelet count ≥ 100 × 109\u002FL. d. Serum bilirubin ≤ 1.5 × institutional upper limit of normal (ULN). (This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\n\ne. Alanine aminotransferase (ALT\u002FSGPT) and aspartate aminotransferase (AST\u002FSGOT) ≤ 2.5 × institutional ULN.\n\nf. Measured creatinine clearance (CL) ≥ 60 mL\u002Fmin or calculated creatinine CL ≥ 60 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.\n\n16\\. Stable cardiac function (no myocardial infarction (MI) within 6 months, no heart failure NYHA III-IV).\n\n17\\. Discussion in a multidisciplinary tumor board which supports participation in this clinical trial, indicating that both chemoradiotherapy and surgery are possible local treatments.\n\nPatients should only be randomized if all of the following inclusion criteria are fulfilled at the time of randomization:\n\n1. Given technical\u002Foncologic complete resectability (R0) at the time of randomization.\n2. Sufficient functional reserves for the planned surgery\n3. Adequate normal organ and bone marrow function as defined before\n\n   Exclusion Criteria:\n\n1\\. Unresectable disease. 2. Mixed histology with areas of small cell carcinoma (neuroendocrine markers). 3. ALK+\u002F EGFRm disease. 4. Clinically symptomatic vena cava superior syndrome. 5. Diffuse mediastinal involvement. 6. Patients with N3 tumors (IASLC\u002FUICC 8). 7. Invasion of the thoracic aorta (T4 - aorta) or the heart (except left atrium - T4 - heart) or the esophagus (T4 - esophagus), or invasion of spine (T4 - spine) NOTE: T4 with invasion of diaphragm are eligible. 8. Pancoast-syndrome in tumors of the superior sulcus (T3-4 Nx). 9. Metastatic disease (M1). 10. Endobronchial tumor extension to the contralateral main stem bronchus. 11. Lung or heart function not allowing the intended surgical procedure at the time of inclusion.\n\n12\\. Prior treatments including prior mediastinal irradiation. 13. Insufficient patients' compliance (e.g., symptomatic psychiatric disorder) or missing written informed consent or definitive refusal for participation.\n\n14\\. Prior randomization of treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n\n15\\.\n\nPatients who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:\n\n1. Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n2. All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n3. Must not have experienced a ≥ Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy.\n\n   NOTE: Patients with endocrine AE of ≤ Grade 2 are permitted to be enrolled if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n4. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.\n\n   16\\. Participation in another clinical study with an investigational product during the last 12 months.\n\n   17\\. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n\n   18\\. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan.\n\n   19\\. Any concurrent chemotherapy (other than study therapy), Investigational Product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n\n   20\\. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of durvalumab.\n\n   21\\. History of allogenic organ transplantation or a stem cell transplantation. 22.\n\n   Active 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\na. Vitiligo or alopecia b. Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement c. Any chronic skin condition that does not require systemic therapy d. Celiac disease controlled by diet alone e. Patients without active disease in the last 5 years may be included but only after consultation with the study physician 23. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n\n24\\. History of another primary malignancy except for\n\na. Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of durvalumab and of low potential risk for recurrence b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease c. Adequately treated carcinoma in situ without evidence of disease 25. History of active primary immunodeficiency. 26. History of leptomeningeal carcinomatosis. 27. Known active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B, hepatitis C, or human immunodeficiency virus (positive HIV-1 or HIV-2). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n\n28\\.\n\nCurrent or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n2. Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 29. Current or prior use of immunostimulatory agents within 14 days before the first dose of durvalumab 30. Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 90 days after the last dose of study treatment.\n\n   31\\. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab or 6 months after the last dose of chemotherapy, whichever occurs last.\n\n   32\\. Known allergy or hypersensitivity to any of the study drugs or any of the study drugs excipient.\n\n   33\\. Any medical contraindication to treatment with platin-based doublet chemotherapy as listed in the applying SmPCs.\n\n   34\\. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.\n\n   Patients should not be randomized if any of the following exclusion criteria are fulfilled at the time of randomization:\n\n   1\\. Complete remission after induction immunochemotherapy. 2.\n\n   Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous immunochemotherapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria:\n\na. Patients with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n\nb. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician (exception: alopecia).\n\n3\\. Allergy or hypersensitivity to durvalumab or concurrent chemotherapy drugs or any excipient appearing for the first time during previous immunochemotherapy.","74 Years",{"count":121,"type":19},176,[22],"The hypothesis of the study is that induction immunochemotherapy, followed by surgery or chemoradiation and consolidation Durvalumab immunotherapy, can significantly improve event-free survival in patients with resectable or borderline resectable NSCLC at stage IIIA\u002FB compared to existing treatment methods.",[25],[117,126,127,128,129,130],"Non-Small Cell Lung Cancer","Chemoradiation","Resectable NSCLC","Durvalumab","Induction Immunochemotherapy","2026-01-25",{"date":133,"type":37},"2026-01-27",{"date":135,"type":37},"2025-04-20",{"date":137,"type":19},"2030-09-30",{"name":139,"class":44},"University Hospital, Bonn",5,{"id":142,"slug":4,"hasResults":10,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":10,"sex":15,"minAge":146,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":162,"locationsCount":4},"100583143","NCT06872489","Expanded Access Protocol for the Use of SL-28 in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n* Subjects with locally advanced or metastatic solid tumor confirmed by histopathology;\n* Having at least one evaluable or measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1);\n* For patients with relapsed\u002Frefractory neuroblastoma with original diagnosis based on tumor histopathology, Karnofsky or Lansky performance status of ≥ 50%;\n* ECOG Performance Status from 0 or 3;\n* The expected survival time is more than 12 weeks;\n* 2 to 65+ old, gender is not limited;\n* The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;\n* Be able to comply with trial and follow-up procedures;\n* Adequate bone marrow and organ function;\n* Patients who have progressed, recurrent or refractory disease after first-line treatment (failure to obtain complete or partial remission after recent treatment);\n* Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse)or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug.\n* The blood HCG test must be negative within 7 days before the start of the study treatment, and must be non-lactating;\n* For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception.\n* Immunotherapy: At least 42 days after completing any type of immunotherapy, including immune checkpoint;\n* Radiation therapy: 60 days should have elapsed in the case of completing radiation.\n* Cytokine therapy (e.g. G-CSF, GM-CSF, IL-6, IL-2): must be discontinued a minimum of 7 days prior to SL-28 therapy.\n\nExclusion Criteria:\n\n* Untreated or active primary central nervous system (CNS) tumor or metastasis;\n* Patients diagnosed of having primary and secondary immunodeficiencies;\n* Patients with disease of any major organ system that would compromise their ability to withstand therapy.\n* Arterial\u002Fvenous thrombosis events that occurred in the 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n* Known allergy to any of the agents or their ingredients used in this study;\n* Patients who are on hemodialysis;\n* Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures;\n* Patients with untreated positive blood cultures or progressive infections.","2 Years","EXPANDED_ACCESS","This is an Expanded Access Program (EAP) that will give the participants access to the drug SL-28 before it is approved by the FDA. Participants in this study will have Advanced Solid Tumors who failed to respond to standard therapy (chemotherapy, immunotherapy) or developed progressive disease at any phase of standard therapy.\n\nResearchers think the SL-28 will be effective because SL-28 has a direct activity against different types of tumors.\n\nSL-28 is a cell-based therapy, based on leukocytes isolated from healthy donors and are activated through the proprietary process. After quality assessment (sterility, viable cell count, purity, and absence of infectious diseases), they are stored at -80°C until use. Upon need, the SL-28 is thawed, followed by checking their viability, count, and sterility. Adult and older adult patients aged 18 to 65+ who meet the eligibility criteria will be included in the study. Patients receive SL-28 IV once daily on days 1-5 and 8-12. Based on the patient's response, the need for additional injections will be evaluated. If improvements in the patient's condition are confirmed by MRI, further injections can continue on a rate 5 days a week.",[150,151,152,153,154,25,92,155,156,157],"Neuroblastoma in Children","Neuroblastoma, Recurrent, Refractory","Advanced Cancer","Advanced Malignant Neoplasm","Prostate Cancer Patients With Bone Metastasis","Gastrointestinal Cancers","Head and Neck Cancer","Pancreatic Cancer","AVAILABLE","2025-07-17",{"date":161,"type":37},"2025-07-23",{"name":163,"class":164},"Second Life Therapeutics","INDUSTRY",{"id":166,"slug":4,"hasResults":10,"nctId":167,"briefTitle":168,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":20,"phases":172,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":45},"100570301","NCT06705465","Cross-sectorial Rehabilitation of Patients with Lung Cancer","Inclusion Criteria:\n\n* patients diagnosed with NSCLC\n* 1\\. line systemic treatment\n\nExclusion Criteria:\n\n* cannot speak, understand, and\u002For read Danish\n* cognitive\u002Fpsychologically unfit to give consent",{"count":171,"type":19},130,[55],"Four thousand seven hundred patients are diagnosed with lung cancer in Denmark every year. Even though cigarette smoking has declined for decades a decline in lung cancer incidence is still at least a decade away. Only 16% of these patients with lung cancer started in a municipal rehabilitation program.\n\nAim: To investigate if the intervention \"early contact conference\" can facilitate acceptance of and participation in municipal rehabilitation in patients with lung cancer. Further, to investigate whether the rehabilitation improve the patients' physical ability and quality of life.\n\nThirteen municipalities from Region Hovedstaden have agreed to participate in this cluster randomized controlled trial. The intervention will focus on creating early contact between the Department of Oncology and the municipalities. The conference call will be planned when the patient is at the hospital for the second systemic treatment and a written status will be sent to the GP after the conference video call so that hospital, municipality, and GP will all have the newest knowledge about the patient's general condition\n\nThe intervention will be easy to implement in clinical practice afterwards if it is a success and the cost of the intervention is low.",[25],[176,177,178],"rehabilitation","cross-sectorial collaboration","video conference","2024-12-13",{"date":181,"type":37},"2024-12-18",{"date":183,"type":37},"2024-10-07",{"date":185,"type":19},"2027-01-01",{"name":187,"class":44},"Camilla Balle",""]