Status:
RECRUITING
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
Lead Sponsor:
Mirati Therapeutics Inc.
Conditions:
Advanced Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
The Phase 2 portion of this study will evaluate the efficacy and safety of MRTX849 as monotherapy and in combination with pembrolizumab. There will be 3 cohorts of patients, all of whom have KRAS G12C...
Eligibility Criteria
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 evaluable or measurable disease per RECIST
-
Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:
- No evidence of brain metastases
- Untreated brain metastases not needing immediate local therapy
- 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
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Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:
- Any untreated brain lesions > 1.0 cm in size
- Any brainstem lesions
- 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.
- 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
Key Trial Info
Start Date :
December 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2029
Estimated Enrollment :
806 Patients enrolled
Trial Details
Trial ID
NCT04613596
Start Date
December 2 2020
End Date
October 31 2029
Last Update
March 18 2026
Active Locations (764)
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1
Local Institution - 007-556-A
Goodyear, Arizona, United States, 85395
2
USOR - Arizona Oncology - Prescott Valley
Prescott Valley, Arizona, United States, 86301
3
Local Institution - 007-568-A
Safford, Arizona, United States, 85546
4
Local Institution - 007-568-B
Safford, Arizona, United States, 85546