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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 - CA239-0009

Updated: 1 October, 2024   |   ClinicalTrials.gov

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Trial Details

  • Phase 2/Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 267

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Phase 2 Cohort 1a: PD-L1 TPS <1%
Drug: Adagrasib
Experimental: Phase 2 Cohort 1b: PD-L1 TPS <1%
Drug: Adagrasib
Experimental: Phase 2 Cohort 2: PD-L1 TPS ≥1%
Drug: Adagrasib
Experimental: Phase 3 Cohort 3 Investigational Arm
Drug: Adagrasib
Active Comparator: Phase 3 Cohort 4 Comparator Arm
Drug: Pembrolizumab

Key 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: 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 > 1.0 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

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