A Phase 3 Study of Front-line Platinum Doublet Therapy With Sotorasib Versus Pembrolizumab in PD-L1 Negative KRAS p.G12C Positive Advanced/Metastatic NSCLC (CodeBreaK 202)
- Conditions
- Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non–Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12CMedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-501863-41-00
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 723
Men or women greater than or equal to 18 years old, 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, ECOG = 1
Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology, Subjects 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method