ClinicaliQ Trial Snapshot
- 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 II • Respiratory / COPD / Asthma • NCT04613596.
- What is being tested: Adagrasib (MRTX849), a KRAS G12C inhibitor, evaluated as monotherapy and combined with pembrolizumab (anti-PD-L1 immunotherapy) in patients with advanced non-small cell lung cancer harbouring KRAS G12C mutations.
- Patient eligibility overview: Adults with advanced NSCLC confirmed to have KRAS G12C mutation, regardless of PD-L1 expression levels, who are suitable candidates for systemic therapy and have not received prior treatment with KRAS or checkpoint inhibitor agents.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS * Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS>=50% * Phase 3: Presence of measurable disease per RECIST1.1 * Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following: 1. No evidence of brain metastases 2. Untreated brain metastases not needing immediate local therapy 3. Previously treated brain metastases not needing immediate local therapy
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.