Study to Compare AMG 510 Proposed INN Sotorasib With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200)
Phase 1
- Conditions
- Previously treated locally advanced and unresectable or metastaticnon-small cell lung cancer (NSCLC) with KRAS p.G12C mutationMedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-508214-42-00
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 571
Inclusion Criteria
Men or women greater than or equal to 18 years old., ECOG = 1, Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment
Exclusion Criteria
Active brain metastases, Myocardial infarction within 6 months of study day 1, Gastrointestinal (GI) tract disease causing the inability to take oral medication
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