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

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.

Trial Details

NCT ID
NCT04613596
Phase
PHASE2 / PHASE3
Sponsor
Mirati Therapeutics Inc.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Adagrasib
  • Pembrolizumab
Locations (sample)
  • Goodyear, Arizona, United States|33.43532,-112.35821
  • Prescott Valley, Arizona, United States|34.61002,-112.31572
  • Safford, Arizona, United States|32.83395,-109.70758
  • Safford, Arizona, United States|32.83395,-109.70758
  • Safford, Arizona, United States|32.83395,-109.70758

Key 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 measurable disease per RECIST1.1
  • Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:

For full eligibility, visit ClinicalTrials.gov.

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