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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

NCT06119581

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

Interventions: LY3537982, Pembrolizumab, Placebo, Cisplatin, Carboplatin

Countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (419)

Huntsville, Alabama, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Springdale, Arkansas, United States
Los Angeles, California, United States
Torrance, California, United States
Walnut Creek, California, United States
Lone Tree, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
Athens, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Springfield, Illinois, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Westwood, Kansas, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
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