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

Sponsor: Eli Lilly and Company

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06119581

Patient View

This study evaluates LY3537982 with immunotherapy and/or chemotherapy in advanced NSCLC with KRAS G12C mutation. Participants must have Stage IIIB-IV non-squamous NSCLC, measurable disease, ECOG 0-1, and specific PD-L1 levels. Interventions include LY3537982 (oral), pembrolizumab, cisplatin, carboplatin, and pemetrexed (IV). Eligibility requires adequate lab parameters and contraceptive use.

Patient Parameters

Program Overview

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.

Description

Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized.

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%.

  • 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.

Get This Program In Your Inbox

You can sign up and apply your patients for this program.