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NCT04685135PHASE3ACTIVE_NOT_RECRUITING

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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Key Facts

Study type
INTERVENTIONAL
Conditions
Metastatic Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer
Interventions
MRTX849, Docetaxel
Enrollment
453 participants
Primary completion
Dec 2023
Study completion
Jul 2026
First posted
Dec 2020
Last updated
Jan 2025

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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Source

Open on ClinicalTrials.gov

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