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Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)
Sponsor: BioNTech SE
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
Conditions
Interventions
Pumitamig
Intravenous infusion
Pembrolizumab
Intravenous infusion
Carboplatin
Intravenous infusion
Pemetrexed
Intravenous infusion
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