Tests olomorasib with pembrolizumab in untreated advanced lung cancer with KRAS G12C mutation

Trial details

Who runs it

Eli Lilly and Company

Trial code

NCT06119581EU 2023-503412-33-00

Record updated

4 November 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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%; Part C: <50%; 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: 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:; 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; 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 known active central nervous system metastases and/or carcinomatous meningitis; Have predominantly squamous cell histology for NSCLC; Is unable or unwilling to take folic acid or vitamin B12 supplementation.

ClinicalTrials.gov NCT06119581 · EU CTIS 2023-503412-33-00