RecruitingPhase 3

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

AR

AZ

CA

CO

CT

DC

FL

GA

IL

IN

KS

KY

LA

MA

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

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

MS

  • North Mississippi Hematology and Oncology Associates · Tupelo, MS 38801Amit Jain · Principal investigatorMore trials in Tupelo

NC

NH

  • Dartmouth-Hitchcock Medical Center · Lebanon, NH 03756Konstantin Dragnev · Principal investigatorMore trials in Lebanon

NJ

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

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

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

SC

TN

TX

VA

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