Study on LY3537982 with Immunotherapy and Possibly Chemotherapy for Non-Small Cell Lung Cancer with KRAS G12C Mutation

Sponsor: Eli Lilly and Company

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06119581

Provider View

This clinical trial is testing whether adding a new drug, LY3537982, to standard cancer treatments is more effective for patients with advanced non-small cell lung cancer (NSCLC) that has a specific gene change called KRAS G12C. The study may last up to 3 years, depending on your health and cancer status.

Patient Parameters

Program Overview

The aim of this study is to find out if combining LY3537982 with standard cancer treatments works better than the standard treatments alone for people with advanced non-small cell lung cancer (NSCLC) that has a KRAS G12C gene mutation. Participants will be involved in the study for up to 3 years, including follow-up visits, to monitor their health and the cancer's response to the treatment.

Description

The study is divided into different parts to find the best dose and to test the treatment's safety and effectiveness. Some parts of the study will randomly assign participants to different treatment groups, while others will not.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) at Stage IIIB-IIIC or Stage IV that cannot be treated with surgery or radiation to cure it.
  • For certain parts of the study, the cancer must be mostly non-squamous type.
  • The cancer must have a KRAS G12C gene mutation.
  • Must know the level of PD-L1 expression in the cancer:
    • Part A: 50% or higher.
    • Part B: Any level from 0% to 100%.
  • Have measurable cancer according to specific medical criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 12 weeks.
  • Be able to swallow capsules.
  • Have adequate blood and other lab test results.
  • Use contraception as per local guidelines for clinical studies.
  • Women of childbearing potential must:
    • Have a negative pregnancy test.
    • Not breastfeed during treatment and for at least 180 days after the study treatment.

Exclusion Criteria

  • Have another known gene mutation that can be targeted with specific treatments, such as EGFR, ALK, BRAF, HER2, MET, ROS1, RET, or NTRK.
  • Have received any previous treatment for advanced or metastatic NSCLC, except for one cycle of standard treatment if immediate treatment was necessary.
  • Have active cancer spread to the brain or spinal cord lining.

Additional Exclusion Criteria for Participants Receiving Pemetrexed and Platinum:

  • Have squamous cell or mixed small cell/non-small cell lung cancer.
  • Cannot stop taking aspirin or other NSAIDs.
  • Cannot or will not take folic acid or vitamin B12 supplements.

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