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

Description

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

Conditions

Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer

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Study Overview

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Study Details

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

A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

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

Condition
Advanced Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Goodyear

Local Institution - 007-556-A, Goodyear, Arizona, United States, 85395

Prescott Valley

USOR - Arizona Oncology - Prescott Valley, Prescott Valley, Arizona, United States, 86301

Safford

Local Institution - 007-568-A, Safford, Arizona, United States, 85546

Safford

Local Institution - 007-568-B, Safford, Arizona, United States, 85546

Safford

Local Institution - 007-568-C, Safford, Arizona, United States, 85546

Safford

Local Institution - 007-568-D, Safford, Arizona, United States, 85546

Safford

Local Institution - 007-568-E, Safford, Arizona, United States, 85546

Tucson

Arizona Clinical Research Center, Tucson, Arizona, United States, 85715

Springdale

Highlands Oncology Group - Springdale, Springdale, Arkansas, United States, 72762

Anaheim

Providence - Saint Joseph Home Health - Anaheim, Anaheim, California, United States, 92805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mirati Therapeutics Inc.,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2029-10-31