[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580727":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":55,"studyPopulation":19,"armGroups":56,"interventions":70,"overallOfficials":83,"centralContacts":87,"locations":94,"responsibleParty":379,"collaborators":381,"id":384,"slug":19,"hasResults":385,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":19,"eligibilityCriteria":389,"healthyVolunteers":385,"sex":390,"minAge":391,"maxAge":19,"enrollmentInfo":392,"targetDuration":19,"studyType":395,"phases":396,"briefSummary":398,"conditions":399,"keywords":401,"overallStatus":97,"whyStopped":19,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":418},{"fullName":5,"class":6},"BioNTech SE","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":19},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Part 1 - Occurrence of dose limiting toxicities (DLTs)","During the DLT evaluation period by dose level","Up to 21 days after first dose of investigational medicinal product (IMP)",{"measure":14,"description":15,"timeFrame":16},"Part 1 and Part 2 - Occurrence of pumitamig treatment emergent adverse events, treatment-related adverse events, treatment emergent serious adverse events, treatment-related serious adverse events, and adverse events of special interest","Graded according to the (United States) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)","From initiation of the first dose of IMP to the 90-day Follow-Up visit",{"measure":18,"description":19,"timeFrame":20},"Part 1 and Part 2 - Occurrence of dose interruption, dose reduction, and\u002For participant discontinuation due to adverse events",null,"From initiation of the first dose of IMP until the 90-day Safety Follow-up visit",{"measure":22,"description":23,"timeFrame":24},"Part 1 and Part 2 - Objective response rate","Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) based on investigator's review) is observed as best overall response.","Up to approximately 2 years",[26,29,32,35,38,41,44,47],{"measure":27,"description":28,"timeFrame":24},"Part 1 and Part 2 - Duration of Response","Defined as the time from first objective response (CR or PR per RECIST v1.1 based on the investigator's assessment) to first occurrence of objective tumor progression (progressive disease, per RECIST v1.1 based on the investigator's assessment) or death from any cause, whichever occurs first.",{"measure":30,"description":31,"timeFrame":24},"Part 1 and Part 2- Progression-free Survival","Based on the investigator's assessment defined as the time from first dose of IMP to the first objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first.",{"measure":33,"description":34,"timeFrame":24},"Part 1 and Part 2 - Depth of Response","Defined as the maximum percent reduction from baseline in tumor size measured by sum of target lesion diameter (including nodal \\[short axis\\] and non-nodal \\[longest axis\\] lesions).",{"measure":36,"description":37,"timeFrame":24},"Part 1 and Part 2 - Disease Control Rate","Defined as the proportion of participants with confirmed CR, confirmed PR, or stable disease (per RECIST v1.1 based on the investigator's assessment) as best overall response.",{"measure":39,"description":40,"timeFrame":24},"Part 1 and Part 2 - Time to Response","Defined as the time from first dose of IMP to first objective response (CR or PR per RECIST v1.1 based on the investigator's assessment).",{"measure":42,"description":43,"timeFrame":24},"Part 1 and Part 2 - Overall Survival","Defined as the time from first dose of IMP to death from any cause",{"measure":45,"description":19,"timeFrame":46},"Part 1 and Part 2 - Pharmacokinetic assessment: Maximum concentration (Cmax) derived from serum concentration of pumitamig","From pre-dose to the end of study treatment (up to approximately 2 years)",{"measure":48,"description":19,"timeFrame":46},"Part 1 and Part 2 - Number of participants developing detectable anti-pumitamig antibodies in serum",{"allocation":50,"interventionModel":51,"interventionModelDescription":19,"primaryPurpose":52,"observationalModel":19,"timePerspective":19,"maskingInfo":53},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":54,"maskingDescription":19,"whoMasked":19},"NONE","If the dose level (either from Part 1A or 1B) seems tolerable, an internal review committee will decide if the study can proceed to Part 2 and enroll additional participants.\n\nIn Part 2, participants who consent will be included in a separate cohort in which they will receive the same treatment as the other participants in Part 2, but in addition to a fresh baseline tumor biopsy, they will be required to provide an on-treatment tumor biopsy sample for additional analyses.\n\nStudy participants will receive pumitamig in combination with docetaxel until disease progression, the occurrence of intolerable toxicity, study participant withdrawal, death, study termination or 2-year limit (whichever comes first).\n\nAfter completion of study treatment, except for participants who withdraw informed consent, a long-term follow-up will be conducted for all participants to record disease progression, subsequent new anticancer treatments, and survival status.",[57,63,66],{"label":58,"type":59,"description":19,"interventionNames":60},"Part 1A - Pumitamig Dose 1 + docetaxel","EXPERIMENTAL",[61,62],"Drug: Pumitamig","Drug: Docetaxel",{"label":64,"type":59,"description":19,"interventionNames":65},"Part 1B - Pumitamig Dose 2 + docetaxel",[61,62],{"label":67,"type":59,"description":68,"interventionNames":69},"Part 2: Selected doses of pumitamig + docetaxel","Pumitamig and docetaxel will be administered at the dose level recommended by an internal review committee based on the observed safety profile from Part 1.",[61,62],[71,80],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"DRUG","Pumitamig","Intravenous infusion",[58,64,67],[77,78,79],"BNT327","PM8002","BMS-986545",{"type":72,"name":81,"description":74,"armGroupLabels":82,"otherNames":19},"Docetaxel",[58,64,67],[84],{"name":85,"affiliation":5,"role":86},"BioNTech Responsible Person","STUDY_DIRECTOR",[88],{"name":89,"role":90,"phone":91,"phoneExt":92,"email":93},"BioNTech clinical trials patient information","CONTACT","+49 6131 9084","0","patients@biontech.de",[95,109,119,129,138,149,161,171,181,191,201,212,221,230,239,245,256,265,271,280,289,299,308,314,323,332,341,352,361,370],{"facility":96,"status":97,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":19},"The University of Alabama at Birmingham Hospital","RECRUITING","Birmingham","Alabama","35249","United States","US",{"type":104,"coordinates":105},"Point",[106,107],-86.80249,33.52066,{"lat":107,"lon":106},{"facility":110,"status":97,"city":111,"state":112,"zip":113,"country":101,"countryCode":102,"cosmosGeoPoint":114,"geoPoint":118,"contacts":19},"Moffitt Cancer Center","Tampa","Florida","33612",{"type":104,"coordinates":115},[116,117],-82.45843,27.94752,{"lat":117,"lon":116},{"facility":120,"status":97,"city":121,"state":122,"zip":123,"country":101,"countryCode":102,"cosmosGeoPoint":124,"geoPoint":128,"contacts":19},"Baptist Health Hardin","Elizabethtown","Kentucky","42701",{"type":104,"coordinates":125},[126,127],-85.85913,37.69395,{"lat":127,"lon":126},{"facility":130,"status":97,"city":131,"state":131,"zip":132,"country":101,"countryCode":102,"cosmosGeoPoint":133,"geoPoint":137,"contacts":19},"NYU Langone - NYU Grossman School of Medicine","New York","10016",{"type":104,"coordinates":134},[135,136],-74.00597,40.71427,{"lat":136,"lon":135},{"facility":139,"status":140,"city":141,"state":142,"zip":143,"country":101,"countryCode":102,"cosmosGeoPoint":144,"geoPoint":148,"contacts":19},"Texas Oncology, P.A.","COMPLETED","Houston","Texas","77090",{"type":104,"coordinates":145},[146,147],-95.36327,29.76328,{"lat":147,"lon":146},{"facility":150,"status":97,"city":151,"state":152,"zip":153,"country":154,"countryCode":155,"cosmosGeoPoint":156,"geoPoint":160,"contacts":19},"Liverpool Cancer Therapy Centre","Liverpool","New South Wales","2170","Australia","AU",{"type":104,"coordinates":157},[158,159],150.92588,-33.91938,{"lat":159,"lon":158},{"facility":162,"status":97,"city":163,"state":164,"zip":165,"country":154,"countryCode":155,"cosmosGeoPoint":166,"geoPoint":170,"contacts":19},"Metro South Health - Princess Alexandra Hospital (PAH)","Woolloongabba","Queensland","4102",{"type":104,"coordinates":167},[168,169],153.03655,-27.48855,{"lat":169,"lon":168},{"facility":172,"status":97,"city":173,"state":174,"zip":175,"country":154,"countryCode":155,"cosmosGeoPoint":176,"geoPoint":180,"contacts":19},"Cancer Research SA (CRSA)","Adelaide","South Austraila","5000",{"type":104,"coordinates":177},[178,179],138.59863,-34.92866,{"lat":179,"lon":178},{"facility":182,"status":97,"city":183,"state":184,"zip":185,"country":154,"countryCode":155,"cosmosGeoPoint":186,"geoPoint":190,"contacts":19},"Hobart Hospital-Royal Hobart Hospital","Hobart","Tasmania","7000",{"type":104,"coordinates":187},[188,189],147.32941,-42.87936,{"lat":189,"lon":188},{"facility":192,"status":97,"city":193,"state":194,"zip":195,"country":154,"countryCode":155,"cosmosGeoPoint":196,"geoPoint":200,"contacts":19},"One Clinical Research - Hollywood Private Hospital","Nedlands","Western Australia","6009",{"type":104,"coordinates":197},[198,199],115.8073,-31.98184,{"lat":199,"lon":198},{"facility":202,"status":97,"city":203,"state":204,"zip":205,"country":206,"countryCode":19,"cosmosGeoPoint":207,"geoPoint":211,"contacts":19},"Gyeongsang National University Hospital (GNUH)","Jinju","Gyeongsangnam-do","52727","South Korea",{"type":104,"coordinates":208},[209,210],128.08472,35.19278,{"lat":210,"lon":209},{"facility":213,"status":97,"city":214,"state":19,"zip":215,"country":206,"countryCode":19,"cosmosGeoPoint":216,"geoPoint":220,"contacts":19},"Chungbuk National University Hospital","Cheongju-si","28644",{"type":104,"coordinates":217},[218,219],127.48972,36.63722,{"lat":219,"lon":218},{"facility":222,"status":97,"city":223,"state":19,"zip":224,"country":206,"countryCode":19,"cosmosGeoPoint":225,"geoPoint":229,"contacts":19},"Gachon University Gil Medical Center","Incheon","21565",{"type":104,"coordinates":226},[227,228],126.70515,37.45646,{"lat":228,"lon":227},{"facility":231,"status":97,"city":232,"state":19,"zip":233,"country":206,"countryCode":19,"cosmosGeoPoint":234,"geoPoint":238,"contacts":19},"Severance Hospital, Yonsei University Health System","Seoul","03722",{"type":104,"coordinates":235},[236,237],126.9784,37.566,{"lat":237,"lon":236},{"facility":240,"status":97,"city":232,"state":19,"zip":241,"country":206,"countryCode":19,"cosmosGeoPoint":242,"geoPoint":244,"contacts":19},"Samsung Medical Center","06351",{"type":104,"coordinates":243},[236,237],{"lat":237,"lon":236},{"facility":246,"status":97,"city":247,"state":19,"zip":248,"country":249,"countryCode":250,"cosmosGeoPoint":251,"geoPoint":255,"contacts":19},"Institut dInvestigacio Biomedica de Bellvitge (IDIBELL)","Barcelona","08908","Spain","ES",{"type":104,"coordinates":252},[253,254],2.15899,41.38879,{"lat":254,"lon":253},{"facility":257,"status":97,"city":258,"state":19,"zip":259,"country":249,"countryCode":250,"cosmosGeoPoint":260,"geoPoint":264,"contacts":19},"Hospital Universitario Ramón y Cajal","Madrid","28034",{"type":104,"coordinates":261},[262,263],-3.70256,40.4165,{"lat":263,"lon":262},{"facility":266,"status":97,"city":258,"state":19,"zip":267,"country":249,"countryCode":250,"cosmosGeoPoint":268,"geoPoint":270,"contacts":19},"Hospital Universitario Fundacion Jimenez Diaz","28040",{"type":104,"coordinates":269},[262,263],{"lat":263,"lon":262},{"facility":272,"status":97,"city":273,"state":19,"zip":274,"country":249,"countryCode":250,"cosmosGeoPoint":275,"geoPoint":279,"contacts":19},"Hospital Universitario Virgen del Rocio","Seville","41013",{"type":104,"coordinates":276},[277,278],-5.97317,37.38283,{"lat":278,"lon":277},{"facility":281,"status":97,"city":282,"state":19,"zip":283,"country":249,"countryCode":250,"cosmosGeoPoint":284,"geoPoint":288,"contacts":19},"Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)","Valencia","46026",{"type":104,"coordinates":285},[286,287],-0.37966,39.47391,{"lat":287,"lon":286},{"facility":290,"status":97,"city":291,"state":19,"zip":292,"country":293,"countryCode":19,"cosmosGeoPoint":294,"geoPoint":298,"contacts":19},"Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus","Adana","01250","Turkey (Türkiye)",{"type":104,"coordinates":295},[296,297],35.32531,36.98615,{"lat":297,"lon":296},{"facility":300,"status":97,"city":301,"state":19,"zip":302,"country":293,"countryCode":19,"cosmosGeoPoint":303,"geoPoint":307,"contacts":19},"Memorial Ankara Hospital","Ankara","06520",{"type":104,"coordinates":304},[305,306],32.85427,39.91987,{"lat":306,"lon":305},{"facility":309,"status":97,"city":301,"state":19,"zip":310,"country":293,"countryCode":19,"cosmosGeoPoint":311,"geoPoint":313,"contacts":19},"Ankara Bilkent City Hospital","06800",{"type":104,"coordinates":312},[305,306],{"lat":306,"lon":305},{"facility":315,"status":97,"city":316,"state":19,"zip":317,"country":293,"countryCode":19,"cosmosGeoPoint":318,"geoPoint":322,"contacts":19},"Memorial Antalya Hospital","Antalya","07090",{"type":104,"coordinates":319},[320,321],30.69556,36.90812,{"lat":321,"lon":320},{"facility":324,"status":97,"city":325,"state":19,"zip":326,"country":293,"countryCode":19,"cosmosGeoPoint":327,"geoPoint":331,"contacts":19},"Yeditepe University Hospital","Istanbul","34752",{"type":104,"coordinates":328},[329,330],28.94966,41.01384,{"lat":330,"lon":329},{"facility":333,"status":97,"city":334,"state":19,"zip":335,"country":293,"countryCode":19,"cosmosGeoPoint":336,"geoPoint":340,"contacts":19},"Koc Universitesi Hastanesi (Koc University Hospital)","Zeytinburnu","34010",{"type":104,"coordinates":337},[338,339],28.90417,40.99441,{"lat":339,"lon":338},{"facility":342,"status":97,"city":343,"state":19,"zip":344,"country":345,"countryCode":346,"cosmosGeoPoint":347,"geoPoint":351,"contacts":19},"Velindre NHS Trust, Velindre Cancer Centre","Cardiff","CF14 2TL","United Kingdom","UK",{"type":104,"coordinates":348},[349,350],-3.18,51.48,{"lat":350,"lon":349},{"facility":353,"status":97,"city":354,"state":19,"zip":355,"country":345,"countryCode":346,"cosmosGeoPoint":356,"geoPoint":360,"contacts":19},"St James's University Hospital - Leeds Teaching Hospitals NHS Trust","Leeds","LS9 7TF",{"type":104,"coordinates":357},[358,359],-1.54785,53.79648,{"lat":359,"lon":358},{"facility":362,"status":97,"city":363,"state":19,"zip":364,"country":345,"countryCode":346,"cosmosGeoPoint":365,"geoPoint":369,"contacts":19},"Sarah Cannon Research Institute","London","W1G 6AD",{"type":104,"coordinates":366},[367,368],-0.12574,51.50853,{"lat":368,"lon":367},{"facility":371,"status":97,"city":372,"state":19,"zip":373,"country":345,"countryCode":346,"cosmosGeoPoint":374,"geoPoint":378,"contacts":19},"The Christie NHS Foundation Trust","Manchester","M20 4BX",{"type":104,"coordinates":375},[376,377],-2.23743,53.48095,{"lat":377,"lon":376},{"type":380,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[382],{"name":383,"class":6},"BioNTech (Shanghai) Pharmaceuticals Co., Ltd.","100580727",false,"NCT06841055","Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment","A Phase II, Multisite, Open-label Trial of Pumitamig (BNT327) in Combination With Standard-of-care Chemotherapy in First-line and Second-line Non-small Cell Lung Cancer (NSCLC)","Key Inclusion Criteria:\n\n* Have histologically or cytologically confirmed diagnosis of Stage IV NSCLC that has documented radiographic progression on one or after one prior line of systemic treatment (programmed death-1 \\[PD-1\\]\u002F programmed death ligand-1 \\[PD-L1\\] inhibitor and platinum-based chemotherapy concomitantly) in advanced\u002Fmetastatic setting per the American Joint Committee on Cancer staging system, 9th edition.\n\n  * Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this study.\n  * Only one prior line of immunotherapy containing regimen is allowed in an advanced\u002Fmetastatic setting. If participant had received adjuvant immunotherapy the disease-free interval (after the last dose of adjuvant immunotherapy) should be at least 6 months.\n  * Historical PD-L1 results must be available.\n  * Participants with actionable genetic alterations may be enrolled if they received locally approved and available targeted agent in combination with immunotherapy in first-line advanced\u002Fmetastatic setting.\n  * Enrollment of participants with primary resistance (best response being radiological progression to prior immunochemotherapy) will be kept below 30% in the overall study population.\n* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been documented after irradiation. Historical images within 28 days of the screening visit may be accepted as a screening image if deemed acceptable in the opinion of the investigator.\n* Participants must provide tumor tissue samples obtained ≤18 months prior to enrollment. For the additional cohort in Part 2, both baseline (freshly obtained) and on-treatment tumor biopsy samples are required.\n* Eastern cooperative oncology group performance status of 0 or 1.\n* Adequate organ function as defined in the protocol.\n\nKey Exclusion Criteria:\n\n* Have a known or suspected hypersensitivity to the study treatments, their metabolites or formulation of excipients including polysorbate 80 (see Docetaxel label).\n* Participants who received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or anti-PD-(L)-1\u002FaVEGF bispecific antibody or docetaxel as monotherapy or in combination with other agents.\n* Have received more than one prior lines of therapies in advanced\u002Fmetastatic setting.\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 (except for docetaxel premedication). Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤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* Participants who have received prior radiotherapy may be enrolled if they have no acute toxicity related to this therapy.\n* Have uncontrolled hypertension or poorly controlled diabetic conditions within 7 days prior to the first dose of 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, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation\u002Ffistula and\u002For the underlying process causing the fistula\u002Fperforation.\n* Participants with significant risk of hemorrhage as defined in the protocol.\n* Have superior vena cava syndrome or symptoms of spinal cord compression.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years",{"count":393,"type":394},60,"ESTIMATED","INTERVENTIONAL",[397],"PHASE2","This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced\u002Fmetastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the combination of pumitamig (also known as BNT327, BMS-986545 or PM8002) with standard of care.\n\nPart 1 is a safety run-in with pumitamig (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants in total to be treated in Part 1A and 1B sequentially.\n\nPart 2 is a dose expansion at the deemed safe dose of pumitamig plus docetaxel and will include up to 54 participants.",[400],"Non-small Cell Lung Cancer",[402,403,404,405,406,407,408],"Second-line treatment","Immunotherapy","Combination with other investigational agents","Bispecific antibody","Vascular endothelial growth factor (VEGF) A","Programmed death-ligand 1 (PD-L1)","Combination with chemotherapy","2026-04-23",{"date":411,"type":412},"2026-04-24","ACTUAL",{"date":414,"type":412},"2025-03-03",{"date":416,"type":394},"2028-10",{"name":5,"class":6},30]