NCT04685135

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

Trial number:: NCT04685135

Trial phase:: 3

Study type:: Targeted therapy, Chemotherapy, Biomarker

Overall status:: Recruiting

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

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 mutation.

Inclusion 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 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),

Conditions

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

Other study ID numbers

849-012

Choose trial site (196)

National Cancer Centre Singapore Recruiting

Farrer Park Recruiting