Status:
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
Lead Sponsor:
Eli Lilly and Company
Conditions:
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ad...
Detailed Description
Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
1016 Patients enrolled
Trial Details
Trial ID
NCT06119581
Start Date
December 21 2023
End Date
October 1 2029
Last Update
December 24 2025
Active Locations (426)
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1
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
2
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
3
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
4
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States, 85719