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)

• Status: Recruiting
• Trial end date: 2031-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Pembrolizumab; Sotorasib

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