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

a study on Lung Cancer Non-Small Cell Lung Cancer Neoplasm Metastasis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Torrance, California and other locations
Dates
study started
completion around
Principal Investigator
by Charity Huang

Description

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.

Official Title

SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression

Details

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

Keywords

Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Non-Small-Cell Lung Carcinoma, Carboplatin, Pembrolizumab, Pemetrexed, Cisplatin, Safety Lead In: LY3537982 plus Pembrolizumab, Pemetrexed and Platinum, LY3537982 plus Pembrolizumab, LY3537982 plus Pembrolizumab, Pemetrexed, and Platinum

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Lead Scientist at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
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 (SUNRAY-01)
ID
NCT06119581
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1016 study participants
Last Updated