RECRUITING

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

Description

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.

Conditions

Carcinoma, Non-Small-Cell LungNeoplasm Metastasis
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Related Conditions:

Carcinoma, Non-Small-Cell LungNeoplasm Metastasis

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment

-

Contacts and Locations

Huntsville

Clearview Cancer Institute, Huntsville, Alabama, United States, 35805

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Phoenix

Banner University Medical Center Phoenix, Phoenix, Arizona, United States, 85006

Tucson

The University of Arizona Cancer Center - North Campus, Tucson, Arizona, United States, 85719

Springdale

Highlands Oncology Group, Springdale, Arkansas, United States, 72762

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Merced

Mercy Cancer Center, Merced, California, United States, 95340

Torrance

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States, 90502

Walnut Creek

BASS Cancer Center, Walnut Creek, California, United States, 94598

Lone Tree

USO - Rocky Mountain Cancer Centers, Lone Tree, Colorado, United States, 80124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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%.
  • * 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
  • * 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:
  • * Have known active central nervous system metastases and/or carcinomatous meningitis.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2029-10