Clinical Trial

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

Recruiting Phase 2/3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 7 changes
notable Primary completion moved earlier: 2032-06-09 -> 2028-10-31 2026-07-10
minor Completion moved earlier: 2032-06-09 -> 2029-10-31 2026-07-10
notable Trial sites expanded: 767 -> 770 locations 2026-06-09
notable Enrollment reduced: 806 -> 626 participants 2026-05-21
notable Trial sites expanded: 764 -> 767 locations 2026-05-21
notable Primary completion pushed: 2028-10-31 -> 2032-06-09 2026-05-21
minor Completion pushed: 2029-10-31 -> 2032-06-09 2026-05-21
Trial Details
NCT Number NCT04613596
Lead Sponsor Mirati Therapeutics Inc.
Conditions Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
Enrollment 626 participants
Start Date 2020-12-02
Primary Completion 2028-10-31 (estimated)
Study Completion 2029-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-05