A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C
18 Years and older, Male and Female
18612 (primary)
NCI-2024-01726
2023-503412-33-00
J3M-MC-JZQB
U1111-1288-0565
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.
Objectives
Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single
arm, non-randomized.
Eligibility
- 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 and after study intervention for at least 180 days.
Treatment Sites in Georgia
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