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RECRUITING
NCT05920356
PHASE3

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

Official title: A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

750

Start Date

2023-11-16

Completion Date

2032-06-29

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

DRUG

Sotorasib

Oral administration

DRUG

Pembrolizumab

Intravenous administration

Locations (424)

Sansum Clinic

Santa Barbara, California, United States

Medical Oncology Hematology Consultants Helen F Graham Cancer Center

Newark, Delaware, United States

Boca Raton Clinical Research Coral Springs

Coral Springs, Florida, United States

Regis Clinical Research LLC

Miami, Florida, United States

Florida Clinical Trials Group Plantation

Plantation, Florida, United States

Florida Clinical Trials Group Tamarac

Tamarac, Florida, United States

University of Illinois Chicago

Chicago, Illinois, United States

Illinois Cancer Specialists

Niles, Illinois, United States

Norton Cancer Institute - Brownsboro

Louisville, Kentucky, United States

Reliant Medical Group Inc

Worcester, Massachusetts, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Messino Cancer Centers Asheville

Asheville, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

FirstHealth Cancer Center

Pinehurst, North Carolina, United States

Dayton Physician's Network

Dayton, Ohio, United States

Alliance Cancer Specialists - Media

Media, Pennsylvania, United States

University of Pittsburgh Medical Center Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Guthrie Medical Group

Sayre, Pennsylvania, United States

Medical University of South Carolina

Florence, South Carolina, United States

Medical University of South Carolina Health Lancaster Medical Center

Lancaster, South Carolina, United States

University of Tennessee Medical Center Knoxville

Knoxville, Tennessee, United States

Regional One Health

Memphis, Tennessee, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, United States

Oncology Consultants PA

Houston, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

US Oncology Research Investigational Products Center

Irving, Texas, United States

Vista Oncology Inc PS

Olympia, Washington, United States

Mercyhealth

Janesville, Wisconsin, United States

Hospital Britanico de Buenos Aires

CABA, Buenos Aires, Argentina

Instituto Alexander Fleming

Capital Federal, Buenos Aires, Argentina

Instituto Argentino de Diagnostico y Tratamiento IADT

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

Fundacion Ars Medica

San Salvador de Jujuy, Jujuy Province, Argentina

Clinica Viedma

Viedma, Río Negro Province, Argentina

Fundacion Estudios Clinicos

Rosario, Santa Fe Province, Argentina

Sanatorio Parque SA

Rosario, Santa Fe Province, Argentina

Centro Oncologico Korben

Buenos Aires, Argentina

Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer

La Rioja, Argentina

Centro de Diagnostico Investigacion y Tratamiento

Salta, Argentina

Campbelltown Hospital

Campbelltown, New South Wales, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Nepean Cancer Centre

Kingswood, New South Wales, Australia

Port Macquarie Base Hospital

Port Macquarie, New South Wales, Australia

GenesisCare -North Shore Oncology

St Leonards, New South Wales, Australia

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

Toowoomba Hospital

Toowoomba, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Cancer Research South Australia

Adelaide, South Australia, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Medizinische Universitaet Graz

Graz, Austria

Klinikum Klagenfurt am Woerthersee

Klagenfurt, Austria

Universitaetsklinikum Krems

Krems, Austria

Klinik Oberwart

Oberwart, Austria

Landeskrankenhaus Salzburg

Salzburg, Austria

Standort Penzing der Klinik Ottakring

Vienna, Austria

Klinikum Wels - Grieskirchen GmbH

Wels, Austria

Chirec - Delta Ziekenhuis

Auderghem, Belgium

Algemeen Ziekenhuis Maria Middelares

Ghent, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Belgium

Centre Hospitalier Regional de la Citadelle

Liège, Belgium

Algemeen Ziekenhuis Sint Maarten-Emmaus vzw

Mechelen, Belgium

Hospital Evangelico de Cachoeiro de Itapemirim

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Núcleo de Oncologia da Bahia

Salvador, Estado de Bahia, Brazil

Hospital Sirio Libanes Brasilia

Brasília, Federal District, Brazil

Oncoclinicas Onco Vida Distrito Federal

Brasília, Federal District, Brazil

Cenantron Centro Avançado de Tratamento Oncologico Ltda

Belo Horizonte, Minas Gerais, Brazil

Nucleo de Ensino Pesquisa e Inovacao Mario Penna

Belo Horizonte, Minas Gerais, Brazil

Centro de Tratamento Oncologico - Cto

Belém, Pará, Brazil

Instituto Medicina Integral Imip

Recife, Pernambuco, Brazil

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, Brazil

Associação Beneficente de Canoas

Canoas, Rio Grande do Sul, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Centro de pesquisa em oncologia Hospital Ana Nery

Santa Cruz do Sul, Rio Grande do Sul, Brazil

Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, Brazil

Fundacao pio xII Barretos

Barretos, São Paulo, Brazil

Santa Casa de Misericordia de Santos - Iscms

Santos, São Paulo, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Beneficencia Portuguesa de Sao Paulo - Bp

São Paulo, São Paulo, Brazil

Fundacao Antonio Prudente

São Paulo, São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, São Paulo, Brazil

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, Brazil

Instituto de Ensino e Pesquisa Sao Lucas Iep Sao Lucas

São Paulo, Brazil

Instituto Cancer Sao Paulo Icesp

São Paulo, Brazil

Multiprofile Hospital for Active Treatment - Uni Hospital OOD

Panagyurishte, Bulgaria

University Multiprofile Hospital for Active Treatment Sveta Marina - Pleven OOD

Pleven, Bulgaria

Multiprofile Hospital for Active Treatment for Womens Health - Nadezhda OOD

Sofia, Bulgaria

Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

Sofia, Bulgaria

Queen Elizabeth II, Health Sciences Centre

Halifax, Nova Scotia, Canada

Sunnybrook Research Institute Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

McGill University Health Centre Glen Site

Montreal, Quebec, Canada

CIUSSS - du Nord-de-lIle-de-Montreal / Hopital Sacre-Coeur de Montreal

Montreal, Quebec, Canada

Institut Universitaire de cardiologie et de pneumologie de Quebec

Québec, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

And 324 more locations on ClinicalTrials.gov