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
- Berlin, Chemnitz, Cologne, Donauwörth, Erfurt, Freiburg im Breisgau, Gauting, Georgsmarienhütte, Gera, Grosshansdorf, Halle (Saale), Hamburg, Heidelberg, Kiel, Muenster, Nuremberg, and Tuebingen, GermanySee 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 Germany
- Charité Campus Virchow-KlinikumBerlin, GermanyTaking people
- Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbHBerlin, GermanyTaking people
- Helios Klinikum Emil von Behring GmbHBerlin, GermanyTaking people
- Klinikum Chemnitz, Klinik fuer Innere Medizin IVChemnitz, GermanyTaking people
- MVZ fuer Haematologie und Onkologie Koeln Am Sachsenring GmbHCologne, GermanyTaking people
- Onkologiezentrum DonauwörthDonauwörth, GermanyTaking people
- HELIOS Klinikum Erfurt GmbHErfurt, GermanyTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, GermanyTaking people
- Asklepios Fachkliniken Muenchen-GautingGauting, GermanyTaking people
- MVZ II der Niels Stensen Kliniken; Franziskus Hospital HarderbergGeorgsmarienhütte, GermanyTaking people
- SRH Wald-Klinikum Gera GmbHGera, GermanyTaking people
- LungenClinic Grosshansdorf GmbHGrosshansdorf, GermanyTaking people
- Christliches Klinikum Halle (Saale) GmbHHalle (Saale), GermanyTaking people
- Asklepios Kliniken Hamburg GmbHHamburg, GermanyTaking people
- Studiengesellschaft Hämato-Onkologie Hamburg - Prof. Laack und PartnerHamburg, GermanyTaking people
- Thoraxklinik Heidelberg gGmbHHeidelberg, GermanyTaking people
- Staedtisches Krankenhaus Kiel GmbHKiel, GermanyTaking people
- Universitaetsklinikum Muenster AöRMuenster, GermanyTaking people
- Klinikum NuernbergNuremberg, GermanyTaking people
- Universitaetsklinikum Tuebingen AöRTuebingen, GermanyTaking 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.