drugset / Trial / NCT04613596

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

NCT04613596

Phase 2/3 Recruiting 626 enrolled Mirati Therapeutics Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.

Timeline

Start
2020-12-02
Primary completion
2028-10-31
Completion
2029-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Adagrasib Small molecule 400 mg Oral
Subject Adagrasib Small molecule 600 mg Oral
Comparator Pembrolizumab Monoclonal antibody 200 mg Intravenous