CTIS2022-501863-41-00RecruitingPhase 1
A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non small Cell Lung Cancers, Negative for PD L1, and Positive for KRAS p.G12C (CodeBreaK 202) - 20190341
Amgen Inc.0 sites723 target enrollmentStarted: July 3, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 723
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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