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)
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)
- Non-Small Cell Lung Cancer (NSCLC)
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Amgen
- Enrolment target
- 750
- Started
- 16 November 2023
- Main results due
- 30 June 2027
- Study sites
- 420
- Registry updated
- 25 September 2026
Can you take part?
- Ages 18 years to 100 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing * No history of systemic anticancer therapy in metastatic/non-curable settings * Eastern Cooperative Oncology Group (ECOG) ≤ 1 Exclusion Criteria: * Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology * Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy * Symptomatic (treated or untreated) brain metastases * Gastrointestinal (GI) tract disease causing the inability to take oral medication * Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina * Prior therapy with a KRAS G12C inhibitor
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(420)
Sansum Clinic
Santa Barbara, California, United States
Recruiting
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware, United States
Recruiting
Boca Raton Clinical Research Coral Springs
Coral Springs, Florida, United States
Recruiting
Florida Clinical Trials Group Plantation
Plantation, Florida, United States
Recruiting
Florida Clinical Trials Group Tamarac
Tamarac, Florida, United States
Recruiting
University of Illinois Chicago
Chicago, Illinois, United States
Recruiting
Illinois Cancer Specialists
Niles, Illinois, United States
Recruiting
Norton Cancer Institute - Brownsboro
Louisville, Kentucky, United States
Completed
Reliant Medical Group Inc
Worcester, Massachusetts, United States
Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Terminated
Messino Cancer Centers Asheville
Asheville, North Carolina, United States
Recruiting
Duke University Medical Center
Durham, North Carolina, United States
Recruiting
FirstHealth Cancer Center
Pinehurst, North Carolina, United States
Recruiting
Dayton Physician's Network
Dayton, Ohio, United States
Recruiting
Alliance Cancer Specialists - Media
Media, Pennsylvania, United States
Recruiting
University of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Terminated
Guthrie Medical Group
Sayre, Pennsylvania, United States
Recruiting
Medical University of South Carolina
Florence, South Carolina, United States
Recruiting
Medical University of South Carolina Health Lancaster Medical Center
Lancaster, South Carolina, United States
Recruiting
University of Tennessee Medical Center Knoxville
Knoxville, Tennessee, United States
Terminated
Regional One Health
Memphis, Tennessee, United States
Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Recruiting
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, United States
Recruiting
Oncology Consultants PA
Houston, Texas, United States
Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
US Oncology Research Investigational Products Center
Irving, Texas, United States
Recruiting
Vista Oncology Inc PS
Olympia, Washington, United States
Recruiting
Mercyhealth
Janesville, Wisconsin, United States
Recruiting
Hospital Britanico de Buenos Aires
CABA, Buenos Aires, Argentina
Terminated
Instituto Alexander Fleming
Capital Federal, Buenos Aires, Argentina
Recruiting
Instituto Argentino de Diagnostico y Tratamiento IADT
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Terminated
Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina
Recruiting
Fundacion Ars Medica
San Salvador de Jujuy, Jujuy Province, Argentina
Terminated
Clinica Viedma
Viedma, Río Negro Province, Argentina
Recruiting
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, Argentina
Recruiting
Sanatorio Parque SA
Rosario, Santa Fe Province, Argentina
Recruiting
Centro Oncologico Korben
Buenos Aires, Argentina
Recruiting
Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer
La Rioja, Argentina
Terminated
Centro de Diagnostico Investigacion y Tratamiento
Salta, Argentina
Recruiting
Campbelltown Hospital
Campbelltown, New South Wales, Australia
Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Recruiting
Nepean Cancer Centre
Kingswood, New South Wales, Australia
Recruiting
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia
Recruiting
GenesisCare -North Shore Oncology
St Leonards, New South Wales, Australia
Completed
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia
Terminated
Toowoomba Hospital
Toowoomba, Queensland, Australia
Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Completed
Cancer Research South Australia
Adelaide, South Australia, Australia
Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Recruiting
The Alfred Hospital
Melbourne, Victoria, Australia
Completed
Medizinische Universitaet Graz
Graz, Austria
Recruiting
Klinikum Klagenfurt am Woerthersee
Klagenfurt, Austria
Recruiting
Universitaetsklinikum Krems
Krems, Austria
Recruiting
Klinik Oberwart
Oberwart, Austria
Recruiting
Landeskrankenhaus Salzburg
Salzburg, Austria
Completed
Klinikum Wels - Grieskirchen GmbH
Wels, Austria
Recruiting
Chirec - Delta Ziekenhuis
Auderghem, Belgium
Completed
Algemeen Ziekenhuis Maria Middelares
Ghent, Belgium
Recruiting
Universitair Ziekenhuis Gent
Ghent, Belgium
Recruiting
Showing 60 of 420 sites — filter to narrow it down. 324 of the 420 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05920356. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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