A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Mirati Therapeutics Inc.
Summary
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA). * Locally advanced or metastatic disease. * Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion. * No prior systemic anti-cancer therapy given for advanced or metastatic disease. * Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection). * Participants with brain metastases are el…
Interventions
- DrugAdagrasib
Specified dose on specified days
- DrugPembrolizumab
Specified dose on specified days
- DrugCarboplatin
Specified dose on specified days
- DrugPemetrexed
Specified dose on specified days
- DrugPlacebo
Specified dose on specified days
- DrugCisplatin
Specified dose on specified days
Locations (351)
- Local Institution - 0347Birmingham, Alabama
- Local Institution - 0686Springdale, Arkansas
- Local Institution - 0581Fullerton, California
- Local Institution - 0682Loma Linda, California
- Helios Clinical ResearchLong Beach, California
- Local Institution - 0442Denver, Colorado