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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
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
Conditions
Interventions
Sotorasib
Oral administration
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