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)
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.
Checked against the public recordLast updated Aug 27, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Amgen
- Interventions being studied
- Drug: Sotorasib; Drug: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Sansum ClinicSanta Barbara, California
- Medical Oncology Hematology Consultants Helen F Graham Cancer CenterNewark, Delaware
- Florida Clinical Trials Group PlantationPlantation, Florida
- Florida Clinical Trials Group TamaracTamarac, Florida
- University of Illinois ChicagoChicago, Illinois
- Illinois Cancer SpecialistsNiles, Illinois
- Norton Cancer Institute - BrownsboroLouisville, Kentucky
- Reliant Medical Group IncWorcester, Massachusetts
- University of New Mexico Cancer CenterAlbuquerque, New Mexico
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Messino Cancer Centers AshevilleAsheville, North Carolina
- Duke University Medical CenterDurham, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 27, 2026. Always confirm current availability with the study team.