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

NCT04685135

Active Not RecruitingPhase 3

Sponsor: Mirati Therapeutics Inc.

Conditions: Metastatic Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer

Interventions: MRTX849, Docetaxel

Countries: United States, Australia, Austria, Belgium, China, Czechia, France, Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 (380)
  • Cerritos, California, United States
  • Duarte, California, United States
  • Glendale, California, United States
  • Huntington Beach, California, United States
  • Irvine, California, United States
  • Long Beach, California, United States
  • Long Beach, California, United States
  • Newport Beach, California, United States
  • Santa Ana, California, United States
  • Santa Rosa, California, United States
  • Torrance, California, United States
  • Denver, Colorado, United States
  • Lafayette, Colorado, United States
  • Lone Tree, Colorado, United States
  • Wheat Ridge, Colorado, United States
  • Fleming Island, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Miami Beach, Florida, United States
  • Orlando, Florida, United States
  • Pensacola, Florida, United States
  • Plantation, Florida, United States
  • Athens, Georgia, United States
  • + 350 more on CT.gov