A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
LY3537982: Administered orally.
Pembrolizumab: Administered IV.
Placebo: Administered orally.
Cisplatin: Administered IV.
Carboplatin: Administered IV.
Pemetrexed: Administered IV.
Study summary
The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.
Eligibility
Primary outcome measure(s)
- Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE) — Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Dose Optimization and Safety Lead-In Part B: Number of Participants with a TEAE - Part A and Part B: Progression-Free Survival (PFS) — Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
Trial sites (416)
| Facility | City | Region | Status |
|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | Recruiting |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | Recruiting |
| Banner University Medical Center Phoenix | Phoenix | Arizona | Recruiting |
| The University of Arizona Cancer Center - North Campus | Tucson | Arizona | Recruiting |
| Highlands Oncology Group | Springdale | Arkansas | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | Recruiting |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | Completed |
| BASS Cancer Center | Walnut Creek | California | Recruiting |
| USO - Rocky Mountain Cancer Centers | Lone Tree | Colorado | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | Recruiting |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | Recruiting |
| Millennium Oncology Research Clinic | Hollywood | Florida | Recruiting |
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | Recruiting |
| Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala | Ocala | Florida | Recruiting |
| Orlando Health Cancer Institute | Orlando | Florida | Recruiting |
| Comprehensive Hematology Oncology | St. Petersburg | Florida | Recruiting |
| University Cancer & Blood Center, LLC | Athens | Georgia | Recruiting |
| Emory University School of Medicine- Grady Campus | Atlanta | Georgia | Recruiting |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | Recruiting |
| University of Illinois at Chicago | Chicago | Illinois | Recruiting |
| University of Chicago Hospital | Chicago | Illinois | Recruiting |
| Springfield Clinic Main Campus | Springfield | Illinois | Recruiting |
| Parkview Research Center at Parkview Regional Medical Center | Fort Wayne | Indiana | Recruiting |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | Recruiting |
| Franciscan Health | Indianapolis | Indiana | Recruiting |
| Community Cancer Center North | Indianapolis | Indiana | Recruiting |
| The University of Kansas Cancer Center - Westwood | Westwood | Kansas | Recruiting |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | Recruiting |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | Recruiting |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | Recruiting |
| USO - Maryland Oncology Hematology | Columbia | Maryland | Recruiting |
| Boston Medical Center | Boston | Massachusetts | Recruiting |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| The Cancer & Hematology Centers | Grand Rapids | Michigan | Recruiting |
| Allina Health Cancer Institute - Abbott Northwestern Hospital | Minneapolis | Minnesota | Recruiting |
| HealthPartners Cancer Research Center | Saint Paul | Minnesota | Recruiting |
| North Mississippi Hematology and Oncology Associates | Tupelo | Mississippi | Recruiting |
| Oncology Hematology Associates | Springfield | Missouri | Recruiting |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | Recruiting |
+ 376 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Eli Lilly and Company trials in South Korea
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 NCT06119581 on ClinicalTrials.gov ↗ ← All trials in South Korea