RecruitingPhase 2Phase 3NCT06712316

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

A Phase II/III, 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


Sponsor

BioNTech SE

Enrollment

1,260 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new immunotherapy drug called BNT327 — which blocks two immune checkpoint proteins (PD-L1 and VEGF) — combined with chemotherapy or other agents as a first-line treatment for advanced non-small cell lung cancer (NSCLC). **You may be eligible if...** - You have Stage IIIB, IIIC, or Stage IV non-small cell lung cancer that cannot be cured with surgery or radiation - You have not received any prior systemic (drug) treatment for your lung cancer - You have at least one measurable tumor on scans **You may NOT be eligible if...** - You have already received systemic treatment for advanced NSCLC - Your cancer does not have a measurable target lesion on imaging - You do not meet health or organ function requirements per the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPumitamig

Intravenous infusion

DRUGPembrolizumab

Intravenous infusion

DRUGCarboplatin

Intravenous infusion

DRUGPemetrexed

Intravenous infusion

DRUGPaclitaxel

Intravenous infusion


Locations(206)

Alaska Oncology and Hematology, LLC

Anchorage, Alaska, United States

John Muir Clinical Research Center

Concord, California, United States

University Of California - San Diego Moores Cancer Center

La Jolla, California, United States

Clermont Oncology Center

Clermont, Florida, United States

Cleveland Clinic Florida - Martin North Hospital

Stuart, Florida, United States

H. Lee Moffit Cancer center and research institute

Tampa, Florida, United States

Cleveland Clinic Weston Hospital

Weston, 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

Frederick Health Hospital- James M Stockman Cancer Institute

Frederick, Maryland, 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

Summit Medical Group PA

Florham Park, New Jersey, United States

The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion

Paramus, New Jersey, United States

Suny-Stony Brook University Cancer Center

Stony Brook, New York, United States

White Plains Hospital

White Plains, New York, United States

Fletcher Hospital, Inc. dba AdventHealth Hendersonville

Hendersonville, North Carolina, United States

Gabrail Cancer Center Research

Canton, Ohio, United States

The Christ Hospital Cancer Center

Cincinnati, Ohio, 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

Kettering Medical Center

Kettering, Ohio, United States

Cleveland Clinic - Hillcrest Hospital

Mayfield Heights, Ohio, United States

INTEGRIS Cancer Institute of Oklahoma

Oklahoma City, Oklahoma, 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

Virginia Cancer Specialists

Fairfax, Virginia, United States

VCU Massey Cancer Center

Richmond, Virginia, 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

Peter MacCallum Cancer Centre

Melbourne, Australia

Monash University - Monash Health -Monash Medical Centre

Melbourne, Australia

Central West Cancer Care Centre

Orange, 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

VITAZ

Sint-Niklaas, Belgium

Affiliated Hospital of Hebei University

Baoding, China

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Jilin Cancer Hospital

Changchun, China

Zhejiang Medical University, Zhejiang Cancer Hospital

Hangzhou, China

Shandong University - Jinan Central Hospital

Jinan, China

Yunnan Provincial Cancer Hospital

Kunming, 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

Zhongnan Hospital of Wuhan University

Wuhan, China

Northern Jiangsu Peoples Hospital (NJPH)

Yangzhou, China

Taizhou Hospital of Zhejiang Province

Zhejiang, 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 Paoli-Calmettes

Marseille, France

Institut Curie - Centre de Recherche

Paris, France

CHU de Rennes, Hopital de Pontchaillou

Rennes, 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

Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

Villejuif, France

Uniklinik RWTH Aachen Medizinische Klinik IV

Aachen, Germany

Evangelische Lungenklinik Berlin

Berlin, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Klinikum Esslingen GmbH

Esslingen am Neckar, Germany

Asklepios Fachkliniken Muenchen Gauting

Gauting, Germany

SRH Wald-Kliniken Gera GmbH

Gera, Germany

Thoraxklinik-Heidelberg Ggmbh

Heidelberg, Germany

Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen

Immenhausen, Germany

University Medical Center of Johannes Gutenberg-University Mainz

Mainz, Germany

MVZ for oncology and hematology Rhein-Kreis Neuss GmbH

Neuss, Germany

Onkologische Tagesklinik Remscheid

Remscheid, 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

Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi

Bologna, Italy

Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona)

Cremona, 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

UOC Oncoematologia AOU Luigi Vanvitelli

Naples, Italy

Casa Di Cura Polispecialistica Dott Pederzoli

Peschiera del Garda, Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, Italy

Istituti di Ricovero e Cura A Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)

Roma, Italy

Fondazione Ospedale Isola Tiberina - Gemelli Isola

Rome, Italy

Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte

Siena, Italy

Ageo Central General Hospital

Ageo, Japan

Tokyo Metropolitan Komagome Hospital

Bunkyō City, Japan

National Hospital Organization Himeji Medical Center

Himeji, Japan

National Hospital Organization Iwakuni Clinical Center

Iwakuni, Japan

Matsusaka Municipal Hospital

Matsusaka, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Japan

National Hospital Organization Tokyo Medical Center

Meguro City, Japan

Iwate Medical University Hospital

Morioka, Japan

Shizuoka Cancer Center

Nagaizumi-chō, Japan

National Hospital Organization Nagoya Medical Center

Nagoya, Japan

Nagoya University Hospital

Nagoya, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Osaka Prefectural Hospital Organization Osaka International Cancer Institute

Osaka, Japan

NHO Kinki Chuo Chest Medical Center

Sakai, Japan

Sendai Kousei Hospital

Sendai, Japan

Wakayama Medical University Hospital

Wakayama, Japan

Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii

Gdansk, Poland

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

Municipal Hospital Ploiesti

Ploieşti, 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

Hospital Universitario de Badajoz

Badajoz, Spain

Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol

Badalona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Consorcio Hospitalario Provincial de Castellón

Castellon, Spain

Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas de Gran Canaria, Spain

Hospital Universitario De Leon

León, Spain

Hospital Universitari de Lleida Arnau de Villanova

Lleida, Spain

Hospital General Universitario Gregorio Maranon (HGUGM)

Madrid, Spain

Clinica MD Anderson International

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitario Nuestra Senora De Valme

Seville, Spain

Fundacion Instituto Valenciano de Oncologia

Valencia, Spain

Hospital General Universitario De Valencia

Valencia, Spain

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

Valencia, Spain

Hospital Alvaro Cunqueiro

Vigo, Spain

Hospital Universitario Miguel Servet de Zaragoza

Zaragoza, Spain

Faculty of Medicine Vajira Hospital, Navamindradhiraj University

Bangkok, Thailand

Chulalongkorn University

Bangkok, Thailand

Chiangrai Prachanukroh Hospital

Chiang Rai, Thailand

Lampang Cancer Hospital

Lampang, Thailand

HRH Princess MahaChakri Sirindhorn Medical Center - Srinakharinwirot University

Nakhon Nayok, Thailand

Rajavithi Hospital

Ratchathewi, Thailand

Baskent Universitesi Tip Fakultesi Adana Hastanesi

Adana, Turkey (Türkiye)

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)

Dicle University Faculty of Medicine Hospital

Diyarbakır, 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)

Karadeniz Technical University Faculty of Medicine

Ortahisar, 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)

Mersin City Training and Research Hospital

Toroslar, 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

Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust

Chelsea, United Kingdom

Hull University Teaching Hospitals NHS Trust

Cottingham, United Kingdom

Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board

Glasgow, United Kingdom

Clatterbridge Cancer Centre

Liverpool, United Kingdom

University College Hospital

London, United Kingdom

Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, 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

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NCT06712316


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