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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

Sponsor: Eli Lilly and Company · Participants: 700 · Started: Mar 27, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06890598

Locations in the U.S.

AlabamaClearview Cancer Institute, Huntsville
Infirmary Cancer Care, Mobile (Not yet recruiting)
ArizonaCity of Hope, Phoenix, Phoenix (Not yet recruiting)
The University of Arizona Cancer Center - North Campus, Tucson
ArkansasHighlands Oncology Group, Springdale
CaliforniaUCLA 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
ConnecticutHartford Hospital (HH), Hartford
District of ColumbiaSibley Memorial Hospital, Washington D.C.
FloridaBoca 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
GeorgiaUniversity Cancer & Blood Center, LLC, Athens
Winship Cancer Institute, Atlanta
City of Hope National Medical Center, Atlanta Cancer Center, Newnan (Not yet recruiting)
IllinoisCity 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
IndianaParkview Research Center at Parkview Regional Medical Center, Fort Wayne
Franciscan Health, Indianapolis
KentuckyBaptist Health Hamburg, Lexington
Baptist Health Lexington, Lexington
LouisianaMary Bird Perkins Cancer Center, Baton Rouge
Ochsner Health Ochsner Cancer Center - Baton Rouge, Baton Rouge
Ochsner Clinic Foundation, New Orleans
MaineNew England Cancer Specialists, Westbrook
MarylandJohns Hopkins Bayview Medical Center, Baltimore
University of Maryland, Baltimore
James M Stockman Cancer Institute, Frederick (Not yet recruiting)
MassachusettsLahey Hospital & Medical Center, Burlington (Not yet recruiting)
Reliant Medical Group, Worcester
MichiganKarmanos Cancer Institute, Detroit
MissouriMissouri Baptist Medical Center, St Louis
New HampshireDartmouth-Hitchcock Medical Center, Lebanon (Not yet recruiting)
New JerseyJefferson Health - Cherry Hill, Cherry Hill
Sidney Kimmel Cancer Center - Washington Township, Sewell
New YorkColumbia University Irving Medical Center, New York
Memorial Sloan Kettering Cancer Center, New York
Northport VA Medical Center, Northport (Not yet recruiting)
North CarolinaWakeMed Raleigh Campus, Raleigh (Not yet recruiting)
OhioAultman 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)
OregonKaiser Permanente Interstate Medical Office Central, Portland
Oregon Health and Science University, Portland
Providence Portland Medical Center, Portland
Providence St. Vincent Medical Center, Portland
PennsylvaniaJefferson Hospital Northeast, Philadelphia
Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office, Philadelphia
AHN Allegheny General Hospital, Pittsburgh
South CarolinaMedical University of South Carolina, Charleston
Lexington Medical Center, West Columbia
South DakotaAvera Cancer Institute- Research, Sioux Falls
TennesseeTennessee Oncology Chattanooga, Chattanooga
University of Tennessee Medical Center, Knoxville
SCRI Oncology Partners, Nashville
Sarah Cannon Research Institute, Nashville
Tennessee Oncology, Nashville
TexasThe 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
VermontThe University of Vermont Medical Center Inc., Burlington
VirginiaUniversity of Virginia Health System, Charlottesville
VCU Health Adult Outpatient Pavillion, Richmond
WashingtonSwedish Cancer Institute - Edmonds, Edmonds
Swedish Medical Center, Seattle
Cancer Care Northwest - Vercler, Spokane Valley
Northwest Cancer Specialists PC, Vancouver
WisconsinUniversity 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.