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
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.
Checked against the public recordLast updated Aug 25, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2 / Phase 3
- Sponsor
- Mirati Therapeutics Inc.
- Interventions being studied
- Drug: Adagrasib; Drug: Adagrasib; Drug: Adagrasib; Drug: Adagrasib; Drug: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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 Exclusion Criteria: * Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510). * Phase 2: Active brain metastases * Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following: 1. Any untreated brain lesions \> 2.0 cm in size 2. Any brainstem lesions 3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \> 10 mg of prednisone (or equivalent) prior to randomization. 4. Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy * Phase 3: Radiation to the lung \> 30 Gy within 6 months prior to the first dose of study treatment
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Local Institution - 007-556-AGoodyear, Arizona
- USOR - Arizona Oncology - Prescott ValleyPrescott Valley, Arizona
- Local Institution - 007-568-ASafford, Arizona
- Local Institution - 007-568-BSafford, Arizona
- Local Institution - 007-568-CSafford, Arizona
- Local Institution - 007-568-DSafford, Arizona
- Local Institution - 007-568-ESafford, Arizona
- Arizona Clinical Research CenterTucson, Arizona
- Highlands Oncology Group - SpringdaleSpringdale, Arkansas
- Providence - Saint Joseph Home Health - AnaheimAnaheim, California
- The Oncology Institute of Hope and Innovation - Corporate OfficeCerritos, California
- Local Institution - 007-777Fountain Valley, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 25, 2026. Always confirm current availability with the study team.