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)
- Trial number:
-
NCT05920356
- Trial phase:
- 3
- Study type:
- Chemotherapy, Targeted therapy
- Overall status:
- Not yet recruiting
Study start date
Scientific title
Summary
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 testingNo history of systemic anticancer therapy in metastatic/non-curable settings Eastern Cooperative Oncology Group (ECOG) ≤ 1
Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histologyParticipants 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