A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Divarasib: Divarasib will be administered orally QD
Pembrolizumab: Pembrolizumab will be administered via IV infusion Q3W
Pemetrexed: Pemetrexed will be administered via IV infusion Q3W
Carboplatin: Carboplatin will be administered via IV infusion Q3W
Cisplatin: Cisplatin will be administered via IV infusion Q3W
Study summary
The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) — Up to approximately 5 years
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause (whichever occurs first) - Overall Survival (OS) — Up to approximately 5 years
OS is defined as the time from randomization to death from any cause
Trial sites (288)
| Facility | City | Region | Status |
|---|---|---|---|
| Alaska Oncology and Hematology | Anchorage | Alaska | Recruiting |
| City of Hope - Phoenix | Goodyear | Arizona | Recruiting |
| Community Cancer Institute (CCI) | Clovis | California | Recruiting |
| Marin Cancer Care Inc | Greenbrae | California | Recruiting |
| UCI Health-CIACC | Irvine | California | Recruiting |
| UCLA Oncology Center | Los Angeles | California | Recruiting |
| Hoag Memorial Hospital | Newport Beach | California | Recruiting |
| University of California Irvine | Orange | California | Recruiting |
| Palo Alto Medical Foundation Research Center | Palo Alto | California | Recruiting |
| Sutter Institute for Medical Research | Roseville | California | Recruiting |
| California Pacific Medical Center | San Francisco | California | Recruiting |
| UC Health Oncology Research | Colorado Springs | Colorado | Recruiting |
| Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System | Fort Collins | Colorado | Recruiting |
| Hartford Hospital | Hartford | Connecticut | Recruiting |
| Florida Cancer Specialists - SOUTH - SCRI - PPDS | Fort Myers | Florida | Recruiting |
| University of Florida Health at Shands | Gainesville | Florida | Recruiting |
| BioResearch Partner | Hialeah | Florida | Recruiting |
| Memorial Healthcare System - Memorial Regional Hospital | Hollywood | Florida | Recruiting |
| Sylvester Comprehensive Cancer Center | Miami | Florida | Recruiting |
| Advent Health Orlando | Orlando | Florida | Recruiting |
| Ascension Sacred Heart | Pensacola | Florida | Recruiting |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | St. Petersburg | Florida | Recruiting |
| Florida Cancer Specialists - EAST - SCRI - PPDS | West Palm Beach | Florida | Recruiting |
| Piedmont Cancer Institute, PC | Atlanta | Georgia | Recruiting |
| City of Hope® Atlanta | Newnan | Georgia | Recruiting |
| Summit Cancer Care PC | Savannah | Georgia | Recruiting |
| St. Luke's Cancer Institute | Boise | Idaho | Recruiting |
| Affiliated Oncologists, LLC | Chicago Ridge | Illinois | Recruiting |
| Hope and Healing Cancer Services | Hinsdale | Illinois | Withdrawn |
| City of Hope® Cancer Center Chicago | Zion | Illinois | Recruiting |
| Mission Cancer + Blood - IMMC | Des Moines | Iowa | Recruiting |
| University of Iowa | Iowa City | Iowa | Recruiting |
| Saint Agnes Hospital - Baltimore - Hunt - PPDS | Baltimore | Maryland | Recruiting |
| Walter Reed National Military Medical Center | Bethesda | Maryland | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | Recruiting |
| Profound Research, LLC | Farmington Hills | Michigan | Recruiting |
| Metro-Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | Recruiting |
| Missouri Baptist Medical Center | St Louis | Missouri | Recruiting |
| NHO Revive Research Institute | Lincoln | Nebraska | Recruiting |
+ 248 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Hoffmann-La Roche trials in Italy
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 NCT06793215 on ClinicalTrials.gov ↗ ← All trials in Italy