Home › Non-Small Cell Lung Cancer › NCT06890598
Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
RecruitingPhase 3
A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria:
* Histological or cytological confirmation of NSCLC.
* Part A
1. Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.
2. Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection.
* Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.
* Must have disease with evidence of KRAS G12C mutation.
* Must have known programmed death-ligand 1 (PD-L1) expression
* Must have an ECOG performance status of 0 or 1.
* Able to swallow oral medication.
* Must have adequate laboratory parameters.
* Contraceptive use should be consistent with local regulations for those participating in clinical studies.
* Women of childbearing potential must
* Have a negative pregnancy test.
* Not be breastfeeding during treatment
Exclusion Criteria:
* Have known, actionable changes in the EGFR or ALK genes.
* Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.
* Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
* Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.About the study
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.
What is being tested
- Olomorasib (drug)
- Pembrolizumab (drug)
- Durvalumab (drug)
- Placebo (drug)
Sponsor: Eli Lilly and Company · Participants: 700 · Started: Mar 27, 2025
Contact the study team
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 1-317-615-4559
Official record on ClinicalTrials.gov — NCT06890598
Locations in the U.S.
| Alabama | Clearview Cancer Institute, Huntsville Infirmary Cancer Care, Mobile (Not yet recruiting) |
| Arizona | City of Hope, Phoenix, Phoenix (Not yet recruiting) The University of Arizona Cancer Center - North Campus, Tucson |
| Arkansas | Highlands Oncology Group, Springdale |
| California | UCLA Hematology/Oncology - Santa Monica, Los Angeles Profound Research LLC, Oceanside University of California, Irvine (UCI) Health - UC Irvine Medical Center, Orange Stanford Cancer Center, Palo Alto Kaiser Permanente San Diego Mission Road, San Diego BASS Cancer Center, Walnut Creek |
| Connecticut | Hartford Hospital (HH), Hartford |
| District of Columbia | Sibley Memorial Hospital, Washington D.C. |
| Florida | Boca Raton Regional Hospital, Boca Raton Florida Cancer Specialists - South, Fort Myers Miami Cancer Institute at Baptist Health, Inc., Miami Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala, Ocala Comprehensive Hematology Oncology, St. Petersburg Florida Cancer Specialists North, St. Petersburg Moffitt Cancer Center, Tampa Florida Cancer Specialists East, West Palm Beach |
| Georgia | University Cancer & Blood Center, LLC, Athens Winship Cancer Institute, Atlanta City of Hope National Medical Center, Atlanta Cancer Center, Newnan (Not yet recruiting) |
| Illinois | City of Hope, Chicago, Chicago (Not yet recruiting) University of Chicago Medical Center, Chicago University of Illinois at Chicago, Chicago Captain James A. Lovell Federal Health Care Center, North Chicago OSF Saint Francis Medical Center, Peoria (Not yet recruiting) Springfield Clinic Main Campus, Springfield |
| Indiana | Parkview Research Center at Parkview Regional Medical Center, Fort Wayne Franciscan Health, Indianapolis |
| Kentucky | Baptist Health Hamburg, Lexington Baptist Health Lexington, Lexington |
| Louisiana | Mary Bird Perkins Cancer Center, Baton Rouge Ochsner Health Ochsner Cancer Center - Baton Rouge, Baton Rouge Ochsner Clinic Foundation, New Orleans |
| Maine | New England Cancer Specialists, Westbrook |
| Maryland | Johns Hopkins Bayview Medical Center, Baltimore University of Maryland, Baltimore James M Stockman Cancer Institute, Frederick (Not yet recruiting) |
| Massachusetts | Lahey Hospital & Medical Center, Burlington (Not yet recruiting) Reliant Medical Group, Worcester |
| Michigan | Karmanos Cancer Institute, Detroit |
| Missouri | Missouri Baptist Medical Center, St Louis |
| New Hampshire | Dartmouth-Hitchcock Medical Center, Lebanon (Not yet recruiting) |
| New Jersey | Jefferson Health - Cherry Hill, Cherry Hill Sidney Kimmel Cancer Center - Washington Township, Sewell |
| New York | Columbia University Irving Medical Center, New York Memorial Sloan Kettering Cancer Center, New York Northport VA Medical Center, Northport (Not yet recruiting) |
| North Carolina | WakeMed Raleigh Campus, Raleigh (Not yet recruiting) |
| Ohio | Aultman Hospital, Canton Miami Valley Hospital South, Centerville (Not yet recruiting) Cleveland Clinic, Cleveland Fairview Hospital, Cleveland (Not yet recruiting) OhioHealth Riverside Methodist Hospital, Columbus The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T, Columbus (Not yet recruiting) Cleveland Clinic - Hillcrest Hospital, Mayfield Heights (Not yet recruiting) |
| Oregon | Kaiser Permanente Interstate Medical Office Central, Portland Oregon Health and Science University, Portland Providence Portland Medical Center, Portland Providence St. Vincent Medical Center, Portland |
| Pennsylvania | Jefferson Hospital Northeast, Philadelphia Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office, Philadelphia AHN Allegheny General Hospital, Pittsburgh |
| South Carolina | Medical University of South Carolina, Charleston Lexington Medical Center, West Columbia |
| South Dakota | Avera Cancer Institute- Research, Sioux Falls |
| Tennessee | Tennessee Oncology Chattanooga, Chattanooga University of Tennessee Medical Center, Knoxville SCRI Oncology Partners, Nashville Sarah Cannon Research Institute, Nashville Tennessee Oncology, Nashville |
| Texas | The Center for Cancer and Blood Disorders, Fort Worth Houston Methodist Hospital, Houston Kelsey-Seybold Clinic, Houston (Not yet recruiting) University of Texas MD Anderson Cancer Center, Houston USO - Texas Oncology - San Antonio, San Antonio USO - Texas Oncology Gulf Coast, Sugar Land USO - US Oncology Research Network, The Woodlands |
| Vermont | The University of Vermont Medical Center Inc., Burlington |
| Virginia | University of Virginia Health System, Charlottesville VCU Health Adult Outpatient Pavillion, Richmond |
| Washington | Swedish Cancer Institute - Edmonds, Edmonds Swedish Medical Center, Seattle Cancer Care Northwest - Vercler, Spokane Valley Northwest Cancer Specialists PC, Vancouver |
| Wisconsin | University Hospital and UW Health Clinics, Madison Medical College of Wisconsin, Milwaukee |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.