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
Recruiting · NCT06119581 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 37 US states.
- Clearview Cancer Institute - Huntsville, Alabama, United States
- Banner MD Anderson Cancer Center - Gilbert, Arizona, United States
- Banner University Medical Center Phoenix - Phoenix, Arizona, United States
- The University of Arizona Cancer Center - North Campus - Tucson, Arizona, United States
- Highlands Oncology Group - Springdale, Arkansas, United States
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance, California, United States
- BASS Cancer Center - Walnut Creek, California, United States
- USO - Rocky Mountain Cancer Centers - Lone Tree, Colorado, United States
- Yale University School of Medicine - New Haven, Connecticut, United States
- Sibley Memorial Hospital - Washington D.C., District of Columbia, United States
- Millennium Oncology Research Clinic - Hollywood, Florida, United States
- University of Florida - Jacksonville - Jacksonville, Florida, United States
- Miami Cancer Institute at Baptist Health, Inc. - Miami, Florida, United States
- Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala - Ocala, Florida, United States
- Orlando Health Cancer Institute - Orlando, Florida, United States
- Comprehensive Hematology Oncology - St. Petersburg, Florida, United States
- University Cancer & Blood Center, LLC - Athens, Georgia, United States
- Emory University School of Medicine- Grady Campus - Atlanta, Georgia, United States
- Winship Cancer Institute, Emory University - Atlanta, Georgia, United States
- University of Illinois at Chicago - Chicago, Illinois, United States
- University of Chicago Hospital - Chicago, Illinois, United States
- Springfield Clinic Main Campus - Springfield, Illinois, United States
- Parkview Research Center at Parkview Regional Medical Center - Fort Wayne, Indiana, United States
- Indiana University Melvin and Bren Simon Cancer Center - Indianapolis, Indiana, United States
- Franciscan Health - Indianapolis, Indiana, United States
- Community Cancer Center North - Indianapolis, Indiana, United States
- The University of Kansas Cancer Center - Westwood - Westwood, Kansas, United States
- CHI Saint Joseph Cancer Center - East - Lexington, Kentucky, United States
- University of Kentucky Chandler Medical Center - Lexington, Kentucky, United States
- Mary Bird Perkins Cancer Center - Baton Rouge, Louisiana, United States
- Johns Hopkins Bayview Medical Center - Baltimore, Maryland, United States
- USO - Maryland Oncology Hematology - Columbia, Maryland, United States
- Boston Medical Center - Boston, Massachusetts, United States
- Lahey Hospital & Medical Center - Burlington, Massachusetts, United States
- University of Michigan - Ann Arbor, Michigan, United States
- The Cancer & Hematology Centers - Grand Rapids, Michigan, United States
- Allina Health Cancer Institute - Abbott Northwestern Hospital - Minneapolis, Minnesota, United States
- HealthPartners Cancer Research Center - Saint Paul, Minnesota, United States
- North Mississippi Hematology and Oncology Associates - Tupelo, Mississippi, United States
- Oncology Hematology Associates - Springfield, Missouri, United States
- Comprehensive Cancer Centers of Nevada - Las Vegas, Nevada, United States
- Dartmouth-Hitchcock Medical Center - Lebanon, New Hampshire, United States
- The Valley Hospital, Inc. - Paramus, New Jersey, United States
- University of New Mexico Comprehensive Cancer Center - Albuquerque, New Mexico, United States
- Maimonides Cancer Center - Brooklyn, New York, United States
- Northwell Health/ RJ Zuckerberg Cancer Center - Lake Success, New York, United States
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island - Mineola, New York, United States
- Laura and Isaac Perlmutter Cancer Center - New York, New York, United States
- Manhattan Eye, Ear and Throat Hospital - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- University of North Carolina Medical Center - Chapel Hill, North Carolina, United States
- Duke Cancer Institute - Durham, North Carolina, United States
- Miami Valley Hospital South - Centerville, Ohio, United States
- USO - Oncology Hematology Care - Cincinnati, Ohio, United States
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T - Columbus, Ohio, United States
- USO - Oncology Associates of Oregon - Eugene, Oregon, United States
- Asante Rogue Regional Medical Center - Medford, Oregon, United States
- Providence Portland Medical Center - Portland, Oregon, United States
- Providence St. Vincent Medical Center - Portland, Oregon, United States
Showing 60 of 418 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →