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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Local Institution - 007-556-A, Goodyear, Arizona, United States
• USOR - Arizona Oncology - Prescott Valley, Prescott Valley, Arizona, United States
• Local Institution - 007-568-A, Safford, Arizona, United States
• Local Institution - 007-568-B, Safford, Arizona, United States
• Local Institution - 007-568-C, Safford, Arizona, United States
• Local Institution - 007-568-D, Safford, Arizona, United States
• Local Institution - 007-568-E, Safford, Arizona, United States
• Arizona Clinical Research Center, Tucson, Arizona, United States
• Highlands Oncology Group - Springdale, Springdale, Arkansas, United States
• Providence - Saint Joseph Home Health - Anaheim, Anaheim, California, United States
• The Oncology Institute of Hope and Innovation - Corporate Office, Cerritos, California, United States
• Local Institution - 007-777, Fountain Valley, California, United States

+ 758 more sites.

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04613596.