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

Trial number:
Trial phase:
Study type:
Targeted therapy, Chemotherapy, Biomarker
Overall status:

Study start date

April, 2021

Scientific title

A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation


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.

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 BICRECOG 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.

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: None (Open Label),


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

Other study ID numbers


Choose trial site (196)

National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting
Farrer Park
Farrer Park Recruiting