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Trial ID CA239-0009  |   NCT04613596

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

Summary

  • Phase 2/Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 265
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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 nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
    1. Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50%
      1. Phase 3: Presence of evaluable or measurable disease per RECIST
        1. Phase 3: CNS Inclusion
          1. 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

            Exclusion Criteria Icon
            :
            • 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).
              1. Phase 2: Active brain metastases
                1. 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
                  1. Phase 3: Radiation to the lung > 30 Gy within 6 months prior to the first dose of study treatment
                    Additional Information *

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: Phase 2 Cohort 1a: PD-L1 TPS <1%

                    ASSIGNED INTERVENTION
                    • Drug: Adagrasib

                    Study Arms

                    Experimental: Phase 2 Cohort 1b: PD-L1 TPS <1%

                    ASSIGNED INTERVENTION
                    • Drug: Adagrasib

                    Study Arms

                    Experimental: Phase 2 Cohort 2: PD-L1 TPS ≥1%

                    ASSIGNED INTERVENTION
                    • Drug: Adagrasib

                    Study Arms

                    Experimental: Phase 3 Cohort 3 Investigational Arm

                    ASSIGNED INTERVENTION
                    • Drug: Adagrasib

                    Study Arms

                    Active Comparator: Phase 3 Cohort 4 Comparator Arm

                    ASSIGNED INTERVENTION
                    • Drug: Pembrolizumab
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