A Randomized Phase 3 Study of MRTX849 versus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation
Trial 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.
Receptor status / problem studied:
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 BICR
- ECOG performance status 0-2
Exclusion criteria
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.
Open for recruitment
Trial Title
KRYSTAL-12
Diagnosis
Lung cancer
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
III
Locations
Investigators
Principal Investigator