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

ID#: NCT06119581

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: December 21, 2023

End Date: October 01, 2029

Contact Information:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
Summary: The purpose of this study is to assess if adding LY3537982 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:

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%.

- 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

- Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)

- Is unable or unwilling to take folic acid or vitamin B12 supplementation.
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