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:

    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

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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Page 1 of 191 (764 locations)

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