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

Recruiting now · Phase 2/Phase 3

Conditions studied: Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT04613596

Run by

Mirati Therapeutics Inc.

People needed

626

Starts

2020-12-02

Expected to finish

2029-10-31

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 measurable disease per RECIST1.1
• Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:
• No evidence of brain metastases
• Untreated brain metastases not needing immediate local therapy
• Previously treated brain metastases not needing immediate local therapy

You may not qualify if…

• 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:
• Any untreated brain lesions > 2.0 cm in size
• Any brainstem lesions
• 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.
• 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

Where it is running

• SCRI - Florida Cancer Specialists - South Region Research Office — Fort Myers, Florida, United States (enrolling)
• SCRI - Florida Cancer Specialists - West Palm Beach — West Palm Beach, Florida, United States (enrolling)
• Eastern Connecticut Hematology and Oncology Associates — Norwich, Connecticut, United States (enrolling)
• Bay Pines Veterans Affairs Healthcare System — Bay Pines, Florida, United States (enrolling)
• USOR - Woodlands Medical Specialists — Pensacola, Florida, United States (enrolling)
• James A. Haley Veterans Hospital — Tampa, Florida, United States (enrolling)
• USOR - Arizona Oncology - Prescott Valley — Prescott Valley, Arizona, United States (enrolling)
• USOR - Rocky Mountain Cancer Centers - Lone Tree — Lone Tree, Colorado, United States (enrolling)
• GenesisCare USA — Aventura, Florida, United States (enrolling)
• The Oncology Institute of Hope and Innovation - Corporate Office — Cerritos, California, United States (enrolling)
• Miami Veterans Affairs Healthcare System — Miami, Florida, United States (enrolling)
• AdventHealth Orlando — Orlando, Florida, United States (enrolling)
• SCRI - Florida Cancer Specialists - Tallahassee Cancer Center — Tallahassee, Florida, United States (enrolling)
• MemorialCare - Long Beach Medical Center — Long Beach, California, United States (enrolling)
• TRIO - Cancer & Blood Specialty Clinic - Los Alamitos — Los Alamitos, California, United States (enrolling)
• Arizona Clinical Research Center — Tucson, Arizona, United States (enrolling)
• Highlands Oncology Group - Springdale — Springdale, Arkansas, United States (enrolling)
• San Francisco Veterans Affairs Medical Center — San Francisco, California, United States (enrolling)
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States (enrolling)
• Providence - Saint Joseph Home Health - Anaheim — Anaheim, California, United States (enrolling)
• Providence Medical Group - Santa Rosa — Santa Rosa, California, United States (enrolling)
• Stockton Hematology Oncology Medical Group (SHOMG) - Stockton (Suite B) — Stockton, California, United States (enrolling)
• 21st Century Oncology of Jacksonville - North Lee Street — Jacksonville, Florida, United States (enrolling)
• Cancer Specialists of North Florida - Southpoint — Jacksonville, Florida, United States (enrolling)
• University Cancer & Blood Center (UCBC) - Athens — Athens, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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