Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Sponsor: Mirati Therapeutics Inc.

Sponsor score: 40

ClinicalTrials ID:NCT04685135

This Phase 3 trial assesses MRTX849 (adagrasib) against docetaxel in previously treated metastatic NSCLC patients with KRAS G12C mutation. Eligible participants must have confirmed NSCLC with this mutation and be candidates for docetaxel. Interventions include 21-day cycles of either MRTX849 or docetaxel. Crossover is allowed upon disease progression per RECIST 1.1 and ECOG status 0-2.

Patient Parameters

Program Overview

This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.

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.

Locations

FACILITYZIPCITYSTATE
Local Institution - 012-89890703CerritosCalifornia
City of Hope - Duarte (Main Campus)91010DuarteCalifornia
Local Institution - 012-898 D91204GlendaleCalifornia
Local Institution - 012-910-A92648Huntington BeachCalifornia
Local Institution - 012-910-C92618IrvineCalifornia
City Of Hope90808Long BeachCalifornia
Local Institution - 012-910-F90813Long BeachCalifornia
Local Institution - 012-910-D92663Newport BeachCalifornia
Local Institution - 012-898 C92705Santa AnaCalifornia
Providence Medical Group - Santa Rosa95403Santa RosaCalifornia

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