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RecruitingPhase 1, Phase 2NCT04956640

Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

◆ AI Clinical Summary

This study tests a new drug called LY3537982 in cancer patients who have a specific genetic mutation called KRAS G12C. The main goals are to determine if the drug is safe and works well for treating non-small cell lung cancer in patients who have already tried standard treatments or cannot tolerate them.

Key Objective:This trial is testing whether LY3537982 can safely and effectively shrink or control lung cancer in patients with the KRAS G12C mutation.

Who to Consider:Patients with non-small cell lung cancer that has the KRAS G12C genetic mutation and who have either tried standard treatments or cannot tolerate them should consider enrolling.

Trial Parameters

ConditionCarcinoma, Non-Small-Cell Lung
SponsorEli Lilly and Company
Study TypeINTERVENTIONAL
PhasePhase 1, Phase 2
Enrollment540
SexALL
Min Age18 Years
Max AgeN/A
Start Date2021-07-19
Completion2027-04
Interventions
LY3537982PembrolizumabCetuximab

Eligibility Fast-Check

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Brief Summary

The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.

Eligibility Criteria

Inclusion Criteria: * Patients have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). * Patients must have disease with evidence of KRAS G12C mutation in tumor tissue or circulating tumor deoxyribonucleic acid (DNA). * Participants must have a histological or a cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and meet cohort-specific criteria. * Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Have adequate organ function. * Have discontinued all previous treatments for cancer with resolution of any significant ongoing adverse events (AEs), (except in certain scenarios). * Must be able to swallow capsule/tablet. * Agree and adhere to contraceptive use, if applicable. * For some parts of the study, (i.e., one of the two arms with LY3537982 in combination with pembrolizumab and the arm of LY3537982 in combination with pembrolizumab, pemetrexed, and platinum therapy) his

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