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
SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 years
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding olomorasib to pembrolizumab, with or without chemotherapy, works better than standard treatment alone. It is for people with advanced non-small cell lung cancer (NSCLC) that has a KRAS G12C gene change and has not yet been treated. Taking part, including follow-up visits, could last up to 3 years.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have NSCLC confirmed by a tissue or cell test, at stage IIIB, IIIC, or IV. Surgery or radiation cannot be used to try to cure it.
- Have the KRAS G12C gene change. For Part B and its safety lead-in, the cancer must be mostly the non-squamous type.
- Have a known PD-L1 level, a protein measured in the cancer: at least 50% for Part A, any level for Part B, or below 50% for Part C.
- Have cancer that can be measured using the study’s rules.
- Be fully active or able to do light work despite limits on hard physical activity. Be expected to live at least 12 weeks.
- Be able to swallow capsules and have lab test results that meet the study’s rules.
- Follow local birth control rules for people in clinical studies.
- If able to become pregnant, have a negative pregnancy test and do not breastfeed during treatment.
Who can't join
- Have another confirmed cancer-driving gene change that can be treated with a targeted drug, such as certain changes in EGFR, ALK, BRAF, HER2, MET, ROS1, RET, or NTRK.
- Have already had drug treatment for advanced or spread NSCLC. One cycle of standard treatment is allowed if treatment was needed right away.
- Have known active cancer spread to the brain or spinal cord, or cancer in the tissues covering them.
- For Part B and its safety lead-in: have mostly squamous-type NSCLC.
- For Part B and its safety lead-in, if you have mild to moderate kidney problems: cannot avoid aspirin, ibuprofen, or similar drugs around pemetrexed treatment. You must stop them 2 days before, on the treatment day, and 2 days after; long-acting drugs must stop 5 days before.
- For Part B and its safety lead-in: cannot or will not take folic acid or vitamin B12 supplements.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy. * Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label). * Must have disease with evidence of KRAS G12C mutation. * Must have known programmed death-ligand 1 (PD-L1) expression * Part A: Greater than or equal to (≥)50 percent (%). * Part B: 0% to 100%. * Part C: \<50%. * Must have measurable disease per RECIST v1.1. * Must have an ECOG performance status of 0 or 1. * Estimated life expectancy ≥12 weeks. * Ability to swallow capsules. * 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 a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1/2/3. * Have had any of the following prior to randomization: \-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC. \--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated: * Have known active central nervous system metastases and/or carcinomatous meningitis. Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B) * Have predominantly squamous cell histology for NSCLC * Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed * Is unable or unwilling to take folic acid or vitamin B12 supplementation.
Study sites (87)
AL
- Clearview Cancer Institute · Huntsville, AL 35805 · Study contact · 256-705-4224Marshall Schreeder · Principal investigatorMore trials in Huntsville
AR
- Highlands Oncology Group · Springdale, AR 72762 · Study contact · 479-872-8130Eric Schaefer · Principal investigatorMore trials in Springdale
AZ
- Banner MD Anderson Cancer Center · Gilbert, AZ 85234 · Study contact · 602-521-3700Todd Erickson · Principal investigatorMore trials in Gilbert
- Banner University Medical Center Phoenix · Phoenix, AZ 85006Jiaxin Niu · Principal investigatorMore trials in Phoenix
- The University of Arizona Cancer Center - North Campus · Tucson, AZ 85719 · Study contact · 520-626-3434Linda Garland · Principal investigatorMore trials in Tucson
CA
- Cedars-Sinai Medical Center · Los Angeles, CA 90048Kamya Sankar · Principal investigatorMore trials in Los Angeles
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Torrance, CA 90502More trials in Torrance
- BASS Cancer Center · Walnut Creek, CA 94598Jewel Johl · Principal investigatorMore trials in Walnut Creek
CO
- USO - Rocky Mountain Cancer Centers · Lone Tree, CO 80124 · Study contact · 303-925-0700Robert Jotte · Principal investigatorMore trials in Lone Tree
CT
- Yale University School of Medicine · New Haven, CT 06510 · Study contact · 475-306-2658So Yeon Kim · Principal investigatorMore trials in New Haven
DC
- Sibley Memorial Hospital · Washington D.C., DC 20016Kristen Marrone · Principal investigatorMore trials in Washington D.C.
FL
- Millennium Oncology Research Clinic · Hollywood, FL 33024 · Study contact · 954-450-1808Isaac Levy · Principal investigatorMore trials in Hollywood
- Miami Cancer Institute at Baptist Health, Inc. · Miami, FL 33176Bruna Pellini · Principal investigatorMore trials in Miami
- Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala · Ocala, FL 34474 · Study contact · 352-732-4032Ketan Doshi · Principal investigatorMore trials in Ocala
- Orlando Health Cancer Institute · Orlando, FL 32806Yuanbin Chen · Principal investigatorMore trials in Orlando
- Comprehensive Hematology Oncology · St. Petersburg, FL 33709 · Study contact · 727-344-6569Neeharika Makani · Principal investigatorMore trials in St. Petersburg
GA
- University Cancer & Blood Center, LLC · Athens, GA 30607 · Study contact · 706-353-2990PETROS NIKOLINAKOS · Principal investigatorMore trials in Athens
- Emory University School of Medicine- Grady Campus · Atlanta, GA 30303 · Study contact · 404-251-5544Ticiana Leal · Principal investigatorMore trials in Atlanta
- Winship Cancer Institute, Emory University · Atlanta, GA 30322 · Study contact · 404-251-5544Ticiana Leal · Principal investigatorMore trials in Atlanta
IL
- University of Illinois at Chicago · Chicago, IL 60612Frank Weinberg · Principal investigatorMore trials in Chicago
- University of Chicago Hospital · Chicago, IL 60637 · Study contact · 773-702-9901Marina Garassino · Principal investigatorMore trials in Chicago
- Springfield Clinic Main Campus · Springfield, IL 62702Preet Singh · Principal investigatorMore trials in Springfield
IN
- Parkview Research Center at Parkview Regional Medical Center · Fort Wayne, IN 46845patricia Rich · Principal investigatorMore trials in Fort Wayne
- Indiana University Melvin and Bren Simon Cancer Center · Indianapolis, IN 46202Gregory Durm · Principal investigatorMore trials in Indianapolis
- Franciscan Health · Indianapolis, IN 46237 · Study contact · 317-859-5252Harsha Ranganath · Principal investigatorMore trials in Indianapolis
- Community Cancer Center North · Indianapolis, IN 46250 · Study contact · 317-621-3858Natraj Ammakkanavar · Principal investigatorMore trials in Indianapolis
KS
- The University of Kansas Cancer Center - Westwood · Westwood, KS 66205 · Study contact · 913-588-6029Chao Huang · Principal investigatorMore trials in Westwood
KY
- University of Kentucky Chandler Medical Center · Lexington, KY 40536 · Study contact · 859-257-9568Susanne Arnold · Principal investigatorMore trials in Lexington
LA
- Mary Bird Perkins Cancer Center · Baton Rouge, LA 70809 · Study contact · 225-215-1185Victor Lin · Principal investigatorMore trials in Baton Rouge
MA
- Boston Medical Center · Boston, MA 02118 · Study contact · 617-638-7584Umit Tapan · Principal investigatorMore trials in Boston
- Lahey Hospital & Medical Center · Burlington, MA 01805 · Study contact · 781-744-8400Andrew Piper-Vallillo · Principal investigatorMore trials in Burlington
MD
- Johns Hopkins Bayview Medical Center · Baltimore, MD 21224Kristen Marrone · Principal investigatorMore trials in Baltimore
- USO - Maryland Oncology Hematology · Columbia, MD 21044Benjamin Bridges · Principal investigatorMore trials in Columbia
MI
- University of Michigan · Ann Arbor, MI 48109Angel Qin · Principal investigatorMore trials in Ann Arbor
- The Cancer & Hematology Centers · Grand Rapids, MI 49503Eric Santos · Principal investigatorMore trials in Grand Rapids
MN
- Allina Health Cancer Institute - Abbott Northwestern Hospital · Minneapolis, MN 55407Charlene Fares · Principal investigatorMore trials in Minneapolis
- HealthPartners Cancer Research Center · Saint Paul, MN 55101Kurt Demel · Principal investigatorMore trials in Saint Paul
MO
- Oncology Hematology Associates · Springfield, MO 65807 · Study contact · 417-882-4880Viran Holden · Principal investigatorMore trials in Springfield
MS
- North Mississippi Hematology and Oncology Associates · Tupelo, MS 38801Amit Jain · Principal investigatorMore trials in Tupelo
NC
- University of North Carolina Medical Center · Chapel Hill, NC 27599Shetal Patel · Principal investigatorMore trials in Chapel Hill
- Duke Cancer Institute · Durham, NC 27710Jeffrey Clarke · Principal investigatorMore trials in Durham
NH
- Dartmouth-Hitchcock Medical Center · Lebanon, NH 03756Konstantin Dragnev · Principal investigatorMore trials in Lebanon
NJ
- The Valley Hospital, Inc. · Paramus, NJ 07652Eli Kirshner · Principal investigatorMore trials in Paramus
NM
- University of New Mexico Comprehensive Cancer Center · Albuquerque, NM 87131Moises Harari Turquie · Principal investigatorMore trials in Albuquerque
NV
- Comprehensive Cancer Centers of Nevada · Las Vegas, NV 89169Liawaty Ho · Principal investigatorMore trials in Las Vegas
NY
- Maimonides Cancer Center · Brooklyn, NY 11220 · Study contact · 718-765-2600Julie Huang · Principal investigatorMore trials in Brooklyn
- Northwell Health/ RJ Zuckerberg Cancer Center · Lake Success, NY 11042Alexander Barbaro · Principal investigatorMore trials in Lake Success
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island · Mineola, NY 11501 · Study contact · 212-731-6363Joshua Sabari · Principal investigatorMore trials in Mineola
- Laura and Isaac Perlmutter Cancer Center · New York, NY 10016 · Study contact · 212-731-6363Joshua Sabari · Principal investigatorMore trials in New York
- Manhattan Eye, Ear and Throat Hospital · New York, NY 10065Alexander Barbaro · Principal investigatorMore trials in New York
- Memorial Sloan Kettering Cancer Center · New York, NY 10065Kathryn Arbour · Principal investigatorMore trials in New York
OH
- Miami Valley Hospital South · Centerville, OH 45459tarek sabagh · Principal investigatorMore trials in Centerville
- USO - Oncology Hematology Care · Cincinnati, OH 45242Patrick Ward · Principal investigatorMore trials in Cincinnati
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T · Columbus, OH 43210 · Study contact · 614-293-3300Timothy Burns · Principal investigatorMore trials in Columbus
OR
- USO - Oncology Associates of Oregon · Eugene, OR 97401 · Study contact · 541-683-5001James E Butrynski · Principal investigatorMore trials in Eugene
- Asante Rogue Regional Medical Center · Medford, OR 97504 · Study contact · 541-789-5003Alison Savage · Principal investigatorMore trials in Medford
- Providence Portland Medical Center · Portland, OR 97213Rachel Sanborn · Principal investigatorMore trials in Portland
- Providence St. Vincent Medical Center · Portland, OR 97225Rachel Sanborn · Principal investigatorMore trials in Portland
- Kaiser Permanente Interstate Medical Office Central · Portland, OR 97227 · Study contact · 503-249-3315Sandeep Mashru · Principal investigatorMore trials in Portland
PA
- USO - Alliance Cancer Specialists, PC · Horsham, PA 19044Joseph Potz · Principal investigatorMore trials in Horsham
- Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office · Philadelphia, PA 19107Sarah Gordon · Principal investigatorMore trials in Philadelphia
- UPMC Hillman Cancer Center · Pittsburgh, PA 15232Liza Villaruz · Principal investigatorMore trials in Pittsburgh
RI
- Lifespan Cancer Institute · Providence, RI 02903Christopher Azzoli · Principal investigatorMore trials in Providence
SC
- Medical University of South Carolina · Charleston, SC 29425Mariam Alexander · Principal investigatorMore trials in Charleston
- Prisma Health Cancer Institute · Greenville, SC 29605Richard O'Neal · Principal investigatorMore trials in Greenville
- Lexington Medical Center · West Columbia, SC 29169 · Study contact · 803-794-7511Scott Graupner · Principal investigatorMore trials in West Columbia
TN
- Tennessee Oncology Chattanooga · Chattanooga, TN 37404Wade Iams · Principal investigatorMore trials in Chattanooga
- University of Tennessee Medical Center · Knoxville, TN 37920 · Study contact · 865-305-8780Ardy Davarifar · Principal investigatorMore trials in Knoxville
- Baptist Memorial Hospital-Memphis · Memphis, TN 38120Osa Ogbeide · Principal investigatorMore trials in Memphis
- Tennessee Oncology · Nashville, TN 37203Wade Iams · Principal investigatorMore trials in Nashville
- USO - US Oncology Research Network · Nashville, TN 37203SMO Sarah Cannon Research Inst. · Principal investigatorMore trials in Nashville
TX
- USO - Texas Oncology · Austin, TX 78745James Uyeki · Principal investigatorMore trials in Austin
- William Beaumont Army Medical Center · Fort Bliss, TX 79918 · Study contact · 915-203-2268Warren Alexander · Principal investigatorMore trials in Fort Bliss
- Houston Methodist Hospital · Houston, TX 77030 · Study contact · 713-441-9948Jun Zhang · Principal investigatorMore trials in Houston
- University of Texas MD Anderson Cancer Center · Houston, TX 77030 · Study contact · 713-792-6363Marcelo Vailati Negrao · Principal investigatorMore trials in Houston
- Lumi Research · Houston, TX 77090David Nguyen · Principal investigatorMore trials in Houston
- USO - Texas Oncology · Webster, TX 77598Pavel Levin · Principal investigatorMore trials in Webster
VA
- University of Virginia Health System · Charlottesville, VA 22903 · Study contact · 434-924-4251Ryan Gentzler · Principal investigatorMore trials in Charlottesville
- USO - Virginia Cancer Specialists · Fairfax, VA 22031Alexander Spira · Principal investigatorMore trials in Fairfax
- VCU Health Adult Outpatient Pavillion · Richmond, VA 23219 · Study contact · 804-828-7999Renato Martins · Principal investigatorMore trials in Richmond
VT
- The University of Vermont Medical Center Inc. · Burlington, VT 05401Rohit Singh · Principal investigatorMore trials in Burlington
WA
- Swedish Cancer Institute - Edmonds · Edmonds, WA 98026Siddhartha Devarakonda · Principal investigatorMore trials in Edmonds
- Kadlec Clinic Hematology and Oncology · Kennewick, WA 99336Ying Zhuo · Principal investigatorMore trials in Kennewick
- Swedish Medical Center · Seattle, WA 98104Siddhartha Devarakonda · Principal investigatorMore trials in Seattle
- VA Puget Sound Health Care System · Seattle, WA 98108Daniel Wu · Principal investigatorMore trials in Seattle
- USO - Northwest Cancer Specialists · Vancouver, WA 98684Anthony Van Ho · Principal investigatorMore trials in Vancouver
WI
- SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical · Madison, WI 53715Lisa Lepeak · Principal investigatorMore trials in Madison