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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

Phase
Phase 3
Sponsor
Eli Lilly and Company
Enrollment
1,016
Timeline
Dec 2023 → Oct 2029
About This Study

The purpose of this study is to assess if adding LY3537982 (olomorasib) 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.

Eligibility Criteria

Inclusion Criteria

  • 1Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.
  • 2Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).
  • 3Must have disease with evidence of KRAS G12C mutation.
  • 4Must have known programmed death-ligand 1 (PD-L1) expression
  • 5Part A: Greater than or equal to (≥)50 percent (%).
  • 6Part B: 0% to 100%.
  • 7Must have measurable disease per RECIST v1.1.
  • 8Must have an ECOG performance status of 0 or 1.
  • 9Estimated life expectancy ≥12 weeks.
  • 10Ability to swallow capsules.
  • 11Must have adequate laboratory parameters.
  • 12Contraceptive use should be consistent with local regulations for those participating in clinical studies.
  • 13Women of childbearing potential must
  • 14Have a negative pregnancy test.
  • 15Not be breastfeeding during treatment

Exclusion Criteria

  • 1Have 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.
  • 2Have had any of the following prior to randomization:
  • 3\-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.
  • 4\--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:
  • 5Have known active central nervous system metastases and/or carcinomatous meningitis.
  • 6Have predominantly squamous cell histology for NSCLC
  • 7Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed
  • 8Is unable or unwilling to take folic acid or vitamin B12 supplementation.

Locations

426 sites participating in this study

Emory University School of Medicine- Grady Campus

Atlanta, Georgia 30303

Recruiting

Ticiana Leal

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

Recruiting

Ticiana Leal

Clearview Cancer Institute

Huntsville, Alabama 35805

Recruiting

Marshall Schreeder

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →