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RECRUITING
NCT06712316
PHASE2/PHASE3

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)

Sponsor: BioNTech SE

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1580

Start Date

2025-01-07

Completion Date

2031-12

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

DRUG

Pumitamig

Intravenous infusion

DRUG

Pembrolizumab

Intravenous infusion

DRUG

Carboplatin

Intravenous infusion

DRUG

Pemetrexed

Intravenous infusion

DRUG

Paclitaxel

Intravenous infusion

Locations (366)

Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology

Birmingham, Alabama, United States

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

Vail Health

Vail, Colorado, United States

MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)

Washington D.C., District of Columbia, United States

MEDSTAR Washington Hospital Center (MedStar Health Research Institute)

Washington D.C., District of Columbia, United States

Clermont Oncology Center

Clermont, Florida, United States

SSAK Partners, LLC.

Coral Springs, Florida, United States

Baptist Medical Center Jacksonville

Jacksonville, Florida, United States

Mid Florida Cancer Centers

Orange City, 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

Northwest Georgia Oncology Centers, P.C.

Marietta, Georgia, United States

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, United States

Indiana University Health University Hospital

Indianapolis, Indiana, 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

Baptist Health Lexington

Lexington, Kentucky, United States

University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center)

Lexington, Kentucky, United States

Frederick Health Hospital- James M Stockman Cancer Institute

Frederick, Maryland, United States

Missouri Cancer Associates

Columbia, Missouri, 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

Nuvance Health

Poughkeepsie, New York, 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

Dayton Physicians Network

Dayton, 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

Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center

Nashville, Tennessee, United States

Millennium Research and Clinical Development, LLC

Houston, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Inova Schar Cancer

Fairfax, Virginia, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Cancer Institute

Richmond, Virginia, United States

VCU Massey Cancer Center

Richmond, Virginia, United States

Shenandoah Oncology

Winchester, Virginia, United States

West Virginia University Hospitals - Mary Babb Randolph Cancer Center

Morgantown, West Virginia, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)

Buenos Aires, Argentina

Instituto Argentino de Diagnóstico y Tratamiento (IADT)

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Sanatorio Allende

Córdoba, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Exelsus SRL

San Miguel de Tucumán, Argentina

Centro de Investigaciones Clinicas. Clinica Viedma S. A

Viedma, Argentina

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

Joondalup Health campus

Joondalup, 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

Clinical Trial Center-Tasman Oncology Research Ltd

Southport, Australia

Western Health Sunshine Hospital

St Albans, Australia

ICON Cancer Care - Townsville

Townsville, Australia

Cancer Care Wollongong Pty Limited

Wollongong, Australia

Universitair Ziekenhuis Gent (Uz Gent)

Ghent, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

CHU HELORA, Hopital de Mons - Site Kennedy

Mons, Belgium

Algemeen Ziekenhuis Delta

Roeselare, Belgium

VITAZ

Sint-Niklaas, Belgium

Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Belgium

Fundacao Pio XII - Hospital de Cancer de Barretos

Barretos, Brazil

CIONC - Centro Integrado de Oncologia de Curitiba

Curitiba, Brazil

Centro Regional Integrado de Oncologia

Fortaleza, Brazil

Oncosite Centro De Pesquisa Clinica Em Oncologia

Ijuí, Brazil

Clinica de Neoplasias Litoral LTDA / Catarina Pesquisa Clínica

Itajaí, Brazil

Bruno Born Hospital

Lajeado, Brazil

Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL

Londrina, Brazil

Liga Norte Riograndense Contra o Cancer - CECAN

Natal, Brazil

Hospital Sao Vicente de Paulo (HSVP)

Passo Fundo, Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Centro Gaucho Integrado de Oncologia e Hematologia - Hospital Mae de Deus/AESC

Porto Alegre, Brazil

Centro Clinico do Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, Brazil

Oncoclinicas Rio de Janeiro S.A (Centro de Tratamento de Tumores Botafogo)

Rio de Janeiro, Brazil

OC Oncoclínicas - Núcleo de Oncologia da Bahia-Ondina (OC Oncoclinicas-NOB Ondina)

Salvador, Brazil

CEON Pesquisas

São Caetano do Sul, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base de Sao Jose do Rio Preto

São José do Vale do Rio Preto, Brazil

IEP Sao Lucas Instituto de Ensino e Pesquisa Sao Lucas

São Paulo, Brazil

And 266 more locations on ClinicalTrials.gov