Phase 2 Trial of MRTX849 Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Advanced Non-Small Cell Lung Cancer focused on measuring KRAS G12C, Non-small cell lung cancer, NSCLC, Metastatic Non-Small Cell Lung Cancer, Adagrasib, Krazati, TPS
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 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
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Active Comparator
Phase 2 Cohort 1a: PD-L1 TPS <1%
Phase 2 Cohort 1b: PD-L1 TPS <1%
Phase 2 Cohort 2: PD-L1 TPS ≥1%
Phase 3 Cohort 3 Investigational Arm
Phase 3 Cohort 4 Comparator Arm
Cohort 1a: Adagrasib twice daily (BID) in combination with pembrolizumab
Cohort 1b: Adagrasib BID monotherapy
Cohort 2: Adagrasib BID in combination with pembrolizumab
Adagrasib BID in combination with pembrolizumab
Pembrolizumab