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Active Not Recruiting
NCT04685135
Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Conditions: Metastatic Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 453
Sponsor: Mirati Therapeutics Inc.
Location: Local Institution - 012-898 Cerritos California
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.
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.
Source: ClinicalTrials.gov (NCT04685135). StuddyBuddy aggregates publicly available trial information.
