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)
Phase 3
630
about 7 years
18+
47 sites in AL, AR, CA +17
What this study is about
Researchers are testing a treatment of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in people with previously untreated non-squamous non-small cell lung cancer who have a KRAS G12C mutation. The trial will last for 2563 days.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Adagrasib
- 2.Take Carboplatin
- 3.Take Cisplatin
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
adagrasib, carboplatin, cisplatin (Platinum chemotherapy; crosslinks DNA to stop replication), pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer), pemetrexed
oral (Oral Tablet), injection, intravenous, infusion, injection (Injection)
Primary: Overall Survival (OS), Progression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR)
Secondary: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scale/item Score, Duration of Response (DOR) as Assessed per RECIST 1.1 by BICR, Number of Deaths, Number of Participants With AEs Leading to Dose Interruption, Number of Participants With AEs Leading to Dose Reduction, Number of Participants With AEs Leading to Treatment Discontinuation, Number of Participants With Adverse Events (AEs), Number of Participants With Serious Adverse Events (SAEs)
Oncology