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)
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
Arms & 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
Outcome measures
Primary
Progression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR)
Time frame: Up to 7 years
Overall Survival (OS)
Time frame: Up to 7 years
Secondary
Overall Response (OR) as Assessed per RECIST v1.1 by BICR
Time frame: Up to 7 years
Duration of Response (DOR) as Assessed per RECIST 1.1 by BICR
Time frame: Up to 7 years
PFS as Assessed per RECIST v1.1 by Investigator
Time frame: Up to 7 years
Number of Participants With Adverse Events (AEs)
Time frame: Up to 90 days from last dose
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 90 days from last dose
Number of Participants With AEs Leading to Dose Interruption
Time frame: Up to 90 days from last dose
Number of Participants With AEs Leading to Dose Reduction
Time frame: Up to 90 days from last dose
Number of Participants With AEs Leading to Treatment Discontinuation
Time frame: Up to 90 days from last dose
Number of Deaths
Time frame: Up to 90 days from last dose
Time to Definitive Deterioration by Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score
Time frame: Up to 7 years
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scale/item Score
Time frame: Up to 90 days from last dose
Eligibility criteria
Study locations (54)
Local Institution - 0347
Birmingham, Alabama, 35294
Local Institution - 0686
Springdale, Arkansas, 72762
Local Institution - 0581
Fullerton, California, 92835
Local Institution - 0682
Loma Linda, California, 92354
Helios Clinical Research
Long Beach, California, 90805
Local Institution - 0442
Denver, Colorado, 80206
Local Institution - 0701
Newark, Delaware, 19713
Local Institution - 0694
Clearwater, Florida, 33756
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
Local Institution - 0696
Miami, Florida, 33176
Local Institution - 0680
Ocala, Florida, 34474
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, 32901
Florida Clinical Trials Group.
Plantation, Florida, 33322
Local Institution - 0695
St. Petersburg, Florida, 33705
Florida Clinical Trials Group.
Tamarac, Florida, 33321
Local Institution - 0647
Tampa, Florida, 33612
Local Institution - 0699
Tampa, Florida, 33612
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
Local Institution - 0676
Chicago, Illinois, 60612
Local Institution - 0683
Springfield, Illinois, 62703
Local Institution - 0454
Dyer, Indiana, 46311
Local Institution - 0684
Fort Wayne, Indiana, 46845
Local Institution - 0423
Munster, Indiana, 46321
Mercy Medical Center
Cedar Rapids, Iowa, 52403
Local Institution - 0366
Edgewood, Kentucky, 41017
Local Institution - 0566
Louisville, Kentucky, 40202
Local Institution - 0693
Owensboro, Kentucky, 42303
Local Institution - 0698
Paducah, Kentucky, 42003
Local Institution - 0644
Shreveport, Louisiana, 71103
Local Institution - 0702
Annapolis, Maryland, 21401
Maryland Oncology Hematology - Columbia
Columbia, Maryland, 21044
Local Institution - 0019
Boston, Massachusetts, 02215
Local Institution - 0293
Detroit, Michigan, 48201
Local Institution - 0685
Fenton, Missouri, 63026
Local Institution - 0678
Cooperstown, New York, 13326
Local Institution - 0689
Rochester, New York, 14642
Ellis Hospital
Schenectady, New York, 12308
Local Institution - 0618
White Plains, New York, 10601
Local Institution - 0624
Asheville, North Carolina, 28806
Local Institution - 0672
Salisbury, North Carolina, 28144
Local Institution - 0688
Easton, Pennsylvania, 18045
Local Institution - 0376
Hershey, Pennsylvania, 17033
WellSpan Oncology Research
York, Pennsylvania, 17403
Local Institution - 0681
Greenville, South Carolina, 29605
Local Institution - 0658
Greenville, South Carolina, 29607
SCRI Oncology Partners
Nashville, Tennessee, 37203
Local Institution - 0697
Nashville, Tennessee, 37212
Local Institution - 0034
Dallas, Texas, 75246
Local Institution - 0692
Galveston, Texas, 77555
Local Institution - 0652
Laredo, Texas, 78041
Texas Oncology - San Antonio
San Antonio, Texas, 78217
Local Institution - 0700
Tyler, Texas, 75702