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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Adagrasib: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
Carboplatin: Specified dose on specified days
Pemetrexed: Specified dose on specified days
Placebo: Specified dose on specified days
Cisplatin: Specified dose on specified days
Study 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
Primary outcome measure(s)
- Progression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR) — Up to 7 years
- Overall Survival (OS) — Up to 7 years
Trial sites (317)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| Highlands Oncology Group - Springdale | Springdale | Arkansas | Recruiting |
| Providence Medical Foundation | Fullerton | California | Recruiting |
| Local Institution - 0682 | Loma Linda | California | Not Yet Recruiting |
| Helios Clinical Research | Long Beach | California | Recruiting |
| National Jewish Health Medical Center | Denver | Colorado | Recruiting |
| Medical Oncology Hematology Consultants, PA | Newark | Delaware | Recruiting |
| Morton Plant Hospital - BayCare Health System | Clearwater | Florida | Recruiting |
| Cancer Specialists of North Florida | Jacksonville | Florida | Recruiting |
| Local Institution - 0696 | Miami | Florida | Not Yet Recruiting |
| Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala | Ocala | Florida | Recruiting |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | Recruiting |
| Cancer Care Centers of Brevard, Inc. | Palm Bay | Florida | Recruiting |
| Florida Clinical Trials Group. | Plantation | Florida | Recruiting |
| St. Anthony's Hospital | St. Petersburg | Florida | Recruiting |
| Florida Clinical Trials Group. | Tamarac | Florida | Recruiting |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | Recruiting |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | Marietta | Georgia | Recruiting |
| Illinois Cancer Specialists | Arlington Heights | Illinois | Recruiting |
| University of Illinois at Chicago | Chicago | Illinois | Recruiting |
| Springfield Clinic Main Campus | Springfield | Illinois | Recruiting |
| Northwest Cancer Centers, P.C. | Dyer | Indiana | Recruiting |
| Parkview Research Center at Parkview Regional Medical Center | Fort Wayne | Indiana | Recruiting |
| Mercy Medical Center | Cedar Rapids | Iowa | Recruiting |
| Saint Elizabeth Medical Center Edgewood | Edgewood | Kentucky | Recruiting |
| The University of Louisville, James Graham Brown Cancer Center | Louisville | Kentucky | Recruiting |
| Owensboro Medical Health System | Owensboro | Kentucky | Recruiting |
| Mercy Health-Paducah Medical Oncology and Hematology | Paducah | Kentucky | Recruiting |
| Louisiana State University Health Sciences Shreveport | Shreveport | Louisiana | Recruiting |
| Velocity Clinical Research, Annapolis | Annapolis | Maryland | Recruiting |
| Maryland Oncology Hematology - Columbia | Columbia | Maryland | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | Recruiting |
| SSM Health Cancer Care - Fenton | Fenton | Missouri | Recruiting |
| Local Institution - 0678 | Cooperstown | New York | Not Yet Recruiting |
| Ellis Hospital | Schenectady | New York | Recruiting |
| White Plains Hospital | White Plains | New York | Recruiting |
| WellSpan Oncology Research | York | Pennsylvania | Recruiting |
| St Francis Cancer Center | Greenville | South Carolina | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | Recruiting |
+ 277 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Mirati Therapeutics Inc. trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06875310 on ClinicalTrials.gov ↗ ← All trials in the UK