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)
Recruiting now Phase 3 NCT05920356
Run by Amgen · for 18 to 100 · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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
🚫 You may not be able to join if…
- 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
Where this trial is running
- Sansum Clinic, Santa Barbara, California, United States
- Medical Oncology Hematology Consultants Helen F Graham Cancer Center, Newark, Delaware, 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
- Alliance Cancer Specialists - Media, Media, Pennsylvania, United States
+ 371 more sites.
Who to contact
Amgen Call Center · 866-572-6436 · medinfo@amgen.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05920356.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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