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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)

RecruitingPhase 3

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)

Who can join

Ages 18 to 100 · All sexes

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

About the study

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.

What is being tested

Sotorasib (drug)
Pembrolizumab (drug)

Sponsor: Amgen · Participants: 750 · Started: Nov 16, 2023

Contact the study team

Amgen Call Center · Phone: 866-572-6436

Official record on ClinicalTrials.gov — NCT05920356

Locations in the U.S.

California	Sansum Clinic, Santa Barbara
Delaware	Medical Oncology Hematology Consultants Helen F Graham Cancer Center, Newark
Florida	Boca Raton Clinical Research Coral Springs, Coral Springs Florida Clinical Trials Group Plantation, Plantation Florida Clinical Trials Group Tamarac, Tamarac
Illinois	University of Illinois Chicago, Chicago Illinois Cancer Specialists, Niles
Massachusetts	Reliant Medical Group Inc, Worcester
New Mexico	University of New Mexico Cancer Center, Albuquerque
North Carolina	Messino Cancer Centers Asheville, Asheville Duke University Medical Center, Durham FirstHealth Cancer Center, Pinehurst
Ohio	Dayton Physician's Network, Dayton
Pennsylvania	Alliance Cancer Specialists - Media, Media Guthrie Medical Group, Sayre
South Carolina	Medical University of South Carolina, Florence Medical University of South Carolina Health Lancaster Medical Center, Lancaster
Tennessee	Regional One Health, Memphis Sarah Cannon Research Institute, Nashville United States Oncology Regulatory Affairs Corporate Office, Nashville
Texas	Oncology Consultants PA, Houston University of Texas MD Anderson Cancer Center, Houston US Oncology Research Investigational Products Center, Irving
Washington	Vista Oncology Inc PS, Olympia
Wisconsin	Mercyhealth, Janesville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.