Recruiting

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

About This Trial
Key Eligibility Criteria
Trial Site Locations

Summary

Phase 2/Phase 3
18+

Age Range
265

Locations
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.

Nearest Recruiting Site

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

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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Trial ID CA239-0009 | NCT04613596

Summary

Overview

Nearest Recruiting Site

Key Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Treatment Options

Study Arms

ASSIGNED INTERVENTION

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