Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
NCT ID: NCT06712316
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
1260 participants
INTERVENTIONAL
2025-01-07
2030-03-31
Brief Summary
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This 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.
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Detailed Description
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The planned study duration per study participant is up to 64 months.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Substudy A Phase 2 - Pumitamig Dose 1 + Carboplatin + Pemetrexed
Pumitamig
Intravenous infusion
Carboplatin
Intravenous infusion
Pemetrexed
Intravenous infusion
Substudy A Phase 2 - Pumitamig Dose 2 + Carboplatin + Pemetrexed
Pumitamig
Intravenous infusion
Carboplatin
Intravenous infusion
Pemetrexed
Intravenous infusion
Substudy A Phase 3 - Pumitamig + Carboplatin + Pemetrexed
Pumitamig dose 3 for Phase 3
Pumitamig
Intravenous infusion
Carboplatin
Intravenous infusion
Pemetrexed
Intravenous infusion
Substudy A Phase 3 - Pembrolizumab + Carboplatin + Pemetrexed
Pembrolizumab
Intravenous infusion
Carboplatin
Intravenous infusion
Pemetrexed
Intravenous infusion
Substudy B Phase 2 - Pumitamig Dose 1 + Carboplatin + Paclitaxel
Pumitamig
Intravenous infusion
Carboplatin
Intravenous infusion
Paclitaxel
Intravenous infusion
Substudy B Phase 2 - Pumitamig Dose 2 + Carboplatin + Paclitaxel
Pumitamig
Intravenous infusion
Carboplatin
Intravenous infusion
Paclitaxel
Intravenous infusion
Substudy B Phase 3 - Pumitamig + Carboplatin + Paclitaxel
Pumitamig dose 3 for Phase 3
Pumitamig
Intravenous infusion
Carboplatin
Intravenous infusion
Paclitaxel
Intravenous infusion
Substudy B Phase 3 - Pembrolizumab + Carboplatin + Paclitaxel
Pembrolizumab
Intravenous infusion
Carboplatin
Intravenous infusion
Paclitaxel
Intravenous infusion
Interventions
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Pumitamig
Intravenous infusion
Pembrolizumab
Intravenous infusion
Carboplatin
Intravenous infusion
Pemetrexed
Intravenous infusion
Paclitaxel
Intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Adequate organ function.
Exclusion Criteria
* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
* Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neo-adjuvant/adjuvant or locally advanced/metastatic setting.
* Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody
* Have received systemic corticosteroids (at a dosage greater than 10 mg/day 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 (\<=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.
* Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
* 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/fistula and/or the underlying process causing fistula/perforation.
* Participants with significant risk of hemorrhage (per investigator clinical judgment).
* Have superior vena cava syndrome or symptoms of spinal cord compression.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
BioNTech SE
INDUSTRY
Responsible Party
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Principal Investigators
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BioNTech Responsible Person
Role: STUDY_DIRECTOR
BioNTech SE
Locations
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Alaska Oncology and Hematology, LLC
Anchorage, Alaska, United States
Clermont Oncology Center
Clermont, Florida, United States
H. Lee Moffit Cancer center and research institute
Tampa, Florida, United States
Physicians Clinic of Iowa
Cedar Rapids, Iowa, United States
Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Baptist Health Hardin
Elizabethtown, Kentucky, United States
SSM Health Cancer Care - St. Clare
Fenton, Missouri, United States
Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC)
Hastings, Nebraska, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
Paramus, New Jersey, United States
White Plains Hospital
White Plains, New York, United States
Fletcher Hospital, Inc. dba AdventHealth Hendersonville
Hendersonville, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Baptist Cancer Center
Memphis, Tennessee, United States
Millennium Research and Clinical Development, LLC
Houston, Texas, United States
Cancer Research SA (CRSA)
Adelaide, , Australia
Royal Adelaide Hospital
Adelaide, , Australia
Flinders Medical Centre
Bedford Park, , Australia
Cairns Hospital
Cairns, , Australia
Dubbo Hospital
Dubbo, , Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, , Australia
Icon Cancer Centre Kurralta Park
Kurralta Park, , Australia
Western Health Sunshine Hospital
St Albans, , Australia
ICON Cancer Care - Townsville
Townsville, , Australia
Cancer Care Wollongong Pty Limited
Wollongong, , Australia
Universitair Ziekenhuis Leuven
Leuven, , Belgium
CHU HELORA, Hopital de Mons - Site Kennedy
Mons, , Belgium
Shandong University - Jinan Central Hospital
Jinan, , China
Jiangsu Peoples Hospital
Nanjing, , China
Shanghai Chest Hospital
Shanghai, , China
Cancer Hospital of Shantou University Medical College
Shantou, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
Chongqing University Three Gorges Hospital
Wanzhou, , China
Centre Hospitalier Universitaire d'Angers (CHU Angers)
Angers, , France
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, , France
CHU Caen Normandie
Caen, , France
Centre Francois Baclesse
Caen, , France
Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)
Créteil, , France
Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau
Saint-Herblain, , France
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
Toulon, , France
Klinikum Esslingen GmbH
Esslingen am Neckar, , Germany
Asklepios Fachkliniken Muenchen Gauting
Gauting, , Germany
Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen
Immenhausen, , Germany
MVZ for oncology and hematology Rhein-Kreis Neuss GmbH
Neuss, , Germany
Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
Wesseling, , Germany
Helios Klinikum Wuppertal-Universitaet Witten-Herdecke
Wuppertal, , Germany
Azienda Ospedaliera San Giuseppe Moscati
Avellino, , Italy
Centro di Riferimento Oncologico
Aviano, , Italy
Ospedale San Luca
Lucca, , Italy
IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori (IRST)
Meldola, , Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, , Italy
Casa Di Cura Polispecialistica Dott Pederzoli
Peschiera del Garda, , Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, , Italy
Fondazione Ospedale Isola Tiberina - Gemelli Isola
Rome, , Italy
Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
Siena, , Italy
Tokyo Metropolitan Komagome Hospital
Bunkyō City, , Japan
Instytut MSF Sp. z o.o.
Lodz, , Poland
NZOZ Medpolonia Sp. Z o.o.
Poznan, , Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, , Poland
Coltea Clinical Hospital
Bucharest, , Romania
SC Gral Medical SRL
Bucharest, , Romania
Cardiomed
Cluj-Napoca, , Romania
S.C. Medisprof S.R.L, Oncologie medicala
Cluj-Napoca, , Romania
Radiotherapy Center Cluj
Cluj-Napoca, , Romania
Onco Clinic Consult SA
Craiova, , Romania
Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center)
Craiova, , Romania
Ovidius Clinical Hospital
Ovidiu, , Romania
Oncomed
Timișoara, , Romania
Chungbuk National University Hospital
Cheongju-si, , South Korea
Chungnam National University Hospital (CNUH)
Daejeon, , South Korea
National Cancer Center
Goyang-si, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Gyeongsang National University Hospital (GNUH)
Jinju, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center (AMC)
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
The Catholic University Of Korea, St. Vincent's Hospital
Suwon, , South Korea
Ajou University Hospital
Suwon, , South Korea
Consorcio Hospitalario Provincial de Castellón
Castellon, , Spain
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, , Spain
Hospital Universitari de Lleida Arnau de Villanova
Lleida, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario Nuestra Senora De Valme
Seville, , Spain
Hospital Universitario Miguel Servet de Zaragoza
Zaragoza, , Spain
Adana City Training and Research Hospital
Adana, , Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, , Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, , Turkey (Türkiye)
Hacettepe University Medicine Faculty
Ankara, , Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, , Turkey (Türkiye)
Liv Hospital Ankara
Ankara, , Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Akdeniz University Hospital
Antalya, , Turkey (Türkiye)
Gaziantep Sanko University Medical Faculty
Gaziantep, , Turkey (Türkiye)
Bezmialem Foundation University Medical Faculty
Istanbul, , Turkey (Türkiye)
Istinye University Bahcesehir Liv Hospital
Istanbul, , Turkey (Türkiye)
Yeditepe University Kosuyolu Hospital
Istanbul, , Turkey (Türkiye)
Medical Point Izmir Hospital
Izmir, , Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Kadıköy, , Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, , Turkey (Türkiye)
Medical Park Florya Hospital
Küçükçekmece, , Turkey (Türkiye)
Sakarya University - Faculty of Medicine
Sakarya, , Turkey (Türkiye)
Ondokuz Mayis University Health Practice and Research Hospital
Samsun, , Turkey (Türkiye)
Acibadem Adana Hospital
Seyhan, , Turkey (Türkiye)
Medical Park Seyhan Hospital
Seyhan, , Turkey (Türkiye)
Gazi University Faculty of Medicine
Yenimahalle, , Turkey (Türkiye)
Koc Universitesi Hastanesi (Koc University Hospital)
Zeytinburnu, , Turkey (Türkiye)
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
Brighton, , United Kingdom
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, , United Kingdom
Hull University Teaching Hospitals NHS Trust
Cottingham, , United Kingdom
University College Hospital
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals
Oxford, , United Kingdom
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-515764-31-00
Identifier Type: CTIS
Identifier Source: secondary_id
BNT327-06
Identifier Type: -
Identifier Source: org_study_id
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