Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Mirati Therapeutics Inc.

Conditions:

Metastatic Non Small Cell Lung Cancer

Advanced Non Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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 mutat...

Eligibility Criteria

Inclusion

  • Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
  • Candidacy to receive treatment with docetaxel.
  • Crossover
  • Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
  • ECOG performance status 0-2

Exclusion

  • Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib).
  • Active brain metastases.
  • Crossover

Key Trial Info

Start Date :

February 23 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 2 2026

Estimated Enrollment :

453 Patients enrolled

Trial Details

Trial ID

NCT04685135

Start Date

February 23 2021

End Date

July 2 2026

Last Update

January 22 2025

Active Locations (343)

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Page 1 of 86 (343 locations)

1

Local Institution - 012-898

Cerritos, California, United States, 90703

2

City of Hope - Duarte (Main Campus)

Duarte, California, United States, 91010

3

Local Institution - 012-898 D

Glendale, California, United States, 91204

4

Local Institution - 012-910-A

Huntington Beach, California, United States, 92648