Overview
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
Recruiting
Trial end date:
2031-03-01
2031-03-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AmgenTreatments:
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