Codebreak 202

Brief Summary

The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

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
• 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