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Trial Information
Molecule Overview
KRAS G12C Inhibitor
Olomorasib
Phase
3
Recruiting
Recruiting Info

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 Expressiona

Related Resources:
SUNRAY-01
Key Inclusion Criteria
  • Histologically or cytologically confirmed non-small cell lung cancer (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 nonsquamous (in line with pemetrexed label)
  • Disease with evidence of KRAS G12C mutation
  • Known programmed death-ligand 1 (PD-L1) expression
    • Part A: ≥50%
    • Part B: 0%-100%
    • Part C: <50%
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Estimated life expectancy ≥12 weeks
  • Ability to swallow capsules
  • 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
Key Exclusion Criteria
  • 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
  • Had any of the following prior to randomization:
    • Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC
    • One cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated
  • Central nervous system (CNS) metastases and/or carcinomatous meningitis
  • For participants receiving pemetrexed and platinum (Part B and safety lead-in Part B):
    • Predominantly squamous cell histology for NSCLC
    • Only 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
    • Is unable or unwilling to take folic acid or vitamin B12 supplementation
a
This clinical trial is being conducted globally.
b
Administered orally.
c
Administered intravenously.
d
Platinum (cisplatin or carboplatin) administered intravenously.
e
Participants with PD-L1 ≥50% are eligible to be enrolled in Part A or Part B at the discretion of the investigator.
f
Participants should be suitable as per investigator's discretion for first-line treatment with a chemotherapy-free regimen to be eligible.
For information on trial enrollment, locations, and more, call 1-877-285-4559.
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