Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation
Sponsor: Mirati Therapeutics Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression-Free Survival (PFS) as Per Blinded Independent Central Review
Time frame: From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks)
Secondary Endpoints
Overall Survival (OS)
Objective Response Rate (ORR) as Per Blinded Independent Central Review
Duration of Response (DOR) as Per Blinded Independent Central Review
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation. * Candidacy to receive treatment with docetaxel. Crossover Inclusion Criteria: * Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR * ECOG performance status 0-2 Exclusion Criteria: * Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib). * Active brain metastases. Crossover Exclusion Criteria: * Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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