Phase 3Recruiting
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
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)
- Sponsor
- Mirati Therapeutics Inc. (Industry)
- Enrolment
- 630 planned
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Adagrasib; Pembrolizumab; Carboplatin; Pemetrexed; Placebo; Cisplatin
- Ages
- adults, older adults
- Registry
- NCT06875310, CTIS2024-515698-85-00
Full record on ClinicalTrials.gov
From the registry
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
Primary outcomes
- Progression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR)
- Overall Survival (OS)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered