Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
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
- Carcinoma, Non-Small-Cell Lung
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Eli Lilly and Company
- Enrolment target
- 700
- Started
- 27 March 2025
- Main results due
- May 2029
- Study sites
- 368
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the 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.What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(368)
Clearview Cancer Institute
Huntsville, Alabama, United States
Recruiting
Infirmary Cancer Care
Mobile, Alabama, United States
Not yet recruiting
City of Hope, Phoenix
Phoenix, Arizona, United States
Not yet recruiting
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
Recruiting
Highlands Oncology Group
Springdale, Arkansas, United States
Recruiting
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States
Recruiting
Profound Research LLC
Oceanside, California, United States
Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, United States
Recruiting
Stanford Cancer Center
Palo Alto, California, United States
Recruiting
Kaiser Permanente San Diego Mission Road
San Diego, California, United States
Recruiting
BASS Cancer Center
Walnut Creek, California, United States
Recruiting
Hartford Hospital (HH)
Hartford, Connecticut, United States
Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Recruiting
Boca Raton Regional Hospital
Boca Raton, Florida, United States
Recruiting
Florida Cancer Specialists - South
Fort Myers, Florida, United States
Recruiting
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States
Recruiting
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala
Ocala, Florida, United States
Recruiting
Florida Cancer Specialists North
St. Petersburg, Florida, United States
Recruiting
Comprehensive Hematology Oncology
St. Petersburg, Florida, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Florida Cancer Specialists East
West Palm Beach, Florida, United States
Recruiting
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Recruiting
Winship Cancer Institute
Atlanta, Georgia, United States
Recruiting
City of Hope National Medical Center, Atlanta Cancer Center
Newnan, Georgia, United States
Not yet recruiting
City of Hope, Chicago
Chicago, Illinois, United States
Not yet recruiting
Northwestern Memorial Hospital
Chicago, Illinois, United States
Suspended
University of Illinois at Chicago
Chicago, Illinois, United States
Recruiting
University of Chicago Medical Center
Chicago, Illinois, United States
Recruiting
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois, United States
Recruiting
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Not yet recruiting
Springfield Clinic Main Campus
Springfield, Illinois, United States
Recruiting
Parkview Research Center at Parkview Regional Medical Center
Fort Wayne, Indiana, United States
Recruiting
Franciscan Health
Indianapolis, Indiana, United States
Recruiting
Baptist Health Lexington
Lexington, Kentucky, United States
Recruiting
Baptist Health Hamburg
Lexington, Kentucky, United States
Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Recruiting
Ochsner Health Ochsner Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States
Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Recruiting
New England Cancer Specialists
Westbrook, Maine, United States
Recruiting
University of Maryland
Baltimore, Maryland, United States
Recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Recruiting
James M Stockman Cancer Institute
Frederick, Maryland, United States
Not yet recruiting
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Not yet recruiting
Reliant Medical Group
Worcester, Massachusetts, United States
Recruiting
Karmanos Cancer Institute
Detroit, Michigan, United States
Recruiting
Missouri Baptist Medical Center
St Louis, Missouri, United States
Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Not yet recruiting
Jefferson Health - Cherry Hill
Cherry Hill, New Jersey, United States
Recruiting
Sidney Kimmel Cancer Center - Washington Township
Sewell, New Jersey, United States
Recruiting
Columbia University Irving Medical Center
New York, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
Northport VA Medical Center
Northport, New York, United States
Not yet recruiting
WakeMed Raleigh Campus
Raleigh, North Carolina, United States
Not yet recruiting
Aultman Hospital
Canton, Ohio, United States
Recruiting
Miami Valley Hospital South
Centerville, Ohio, United States
Not yet recruiting
Fairview Hospital
Cleveland, Ohio, United States
Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, United States
Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, United States
Not yet recruiting
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
Recruiting
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, United States
Not yet recruiting
Showing 60 of 368 sites — filter to narrow it down. 343 of the 368 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06890598. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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