Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Olomorasib: Administered orally.
Pembrolizumab: Administered intravenously (IV).
Durvalumab: Administered IV.
Placebo: Administered orally.
Study summary
The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.
Eligibility
Primary outcome measure(s)
- Part A: Disease-Free Survival (DFS) by Investigator Assessment — Randomization to disease recurrence or death from any cause (Estimated as approximately 4 years).
DFS by Investigator Assessment - Part B: Progression-Free Survival (PFS) by BICR — Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
Trial sites (366)
| Facility | City | Region | Status |
|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | Recruiting |
| Infirmary Cancer Care | Mobile | Alabama | Not Yet Recruiting |
| City of Hope, Phoenix | Phoenix | Arizona | Not Yet Recruiting |
| The University of Arizona Cancer Center - North Campus | Tucson | Arizona | Recruiting |
| Highlands Oncology Group | Springdale | Arkansas | Recruiting |
| UCLA Hematology/Oncology - Santa Monica | Los Angeles | California | Recruiting |
| Profound Research LLC | Oceanside | California | Recruiting |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center | Orange | California | Recruiting |
| Stanford Cancer Center | Palo Alto | California | Recruiting |
| Kaiser Permanente San Diego Mission Road | San Diego | California | Recruiting |
| BASS Cancer Center | Walnut Creek | California | Recruiting |
| Hartford Hospital (HH) | Hartford | Connecticut | Recruiting |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | Recruiting |
| Boca Raton Regional Hospital | Boca Raton | Florida | Recruiting |
| Florida Cancer Specialists - South | Fort Myers | Florida | Recruiting |
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | Recruiting |
| Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala | Ocala | Florida | Recruiting |
| Florida Cancer Specialists North | St. Petersburg | Florida | Recruiting |
| Comprehensive Hematology Oncology | St. Petersburg | Florida | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| Florida Cancer Specialists East | West Palm Beach | Florida | Recruiting |
| University Cancer & Blood Center, LLC | Athens | Georgia | Recruiting |
| Winship Cancer Institute | Atlanta | Georgia | Recruiting |
| City of Hope National Medical Center, Atlanta Cancer Center | Newnan | Georgia | Not Yet Recruiting |
| City of Hope, Chicago | Chicago | Illinois | Not Yet Recruiting |
| Northwestern Memorial Hospital | Chicago | Illinois | Suspended |
| University of Illinois at Chicago | Chicago | Illinois | Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | Recruiting |
| Captain James A. Lovell Federal Health Care Center | North Chicago | Illinois | Recruiting |
| OSF Saint Francis Medical Center | Peoria | Illinois | Not Yet Recruiting |
| Springfield Clinic Main Campus | Springfield | Illinois | Recruiting |
| Parkview Research Center at Parkview Regional Medical Center | Fort Wayne | Indiana | Recruiting |
| Franciscan Health | Indianapolis | Indiana | Recruiting |
| Baptist Health Lexington | Lexington | Kentucky | Recruiting |
| Baptist Health Hamburg | Lexington | Kentucky | Recruiting |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | Recruiting |
| Ochsner Health Ochsner Cancer Center - Baton Rouge | Baton Rouge | Louisiana | Recruiting |
| Ochsner Clinic Foundation | New Orleans | Louisiana | Recruiting |
| New England Cancer Specialists | Westbrook | Maine | Recruiting |
| University of Maryland | Baltimore | Maryland | Recruiting |
+ 326 more sites — see the full list on the official registry below.
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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 NCT06890598 on ClinicalTrials.gov ↗ ← All trials in Japan