Tests olomorasib with pembrolizumab in untreated advanced lung cancer with KRAS G12C mutation
Tests olomorasib added to standard drugs in adults with untreated advanced KRAS G12C lung cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- A Coruña, Badajoz, Barakaldo, Barcelona, Jerez de la Frontera, L'Hospitalet de Llobregat, Las Palmas de Gran Canaria, León, Madrid, Málaga, Palma, Pamplona, Pozuelo de Alarcón, Santiago de Compostela, Sevilla, Valencia, and Zaragoza, SpainSee the 20 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- Has your cancer spread to the brain?
- Has your cancer spread to the lining around the brain or spinal cord?
Source: NCT06119581, who can take part
Where in Spain
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpainTaking people
- Hospital Universitario Infanta CristinaBadajoz, SpainTaking people
- Hospital Universitario de CrucesBarakaldo, SpainTaking people
- Hospital del MarBarcelona, SpainTaking people
- Hospital Universitari Dexeus Grupo QuironsaludBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital de Jerez de la FronteraJerez de la Frontera, SpainTaking people
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainTaking people
- Complejo Hospitalario Universitario Insular Materno InfantilLas Palmas de Gran Canaria, SpainTaking people
- Hospital Universitario De LeonLeón, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital Universitario Regional de MálagaMálaga, SpainTaking people
- University Hospital Son EspasesPalma, SpainTaking people
- Hospital Universitario de NavarraPamplona, SpainTaking people
- Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpainTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpainTaking people
- Hospital Clinico Universitario Lozano BlesaZaragoza, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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.