Tests olomorasib with immunotherapy for KRAS G12C lung cancer
Tests olomorasib with immunotherapy in adults with KRAS G12C non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
Key facts
- Where
- Bobigny, Bron, La Tronche, Lyon Cedex08, Marseille, Nice, Paris, Pessac, Poitiers, Reims, Rennes, Toulouse, Vantoux, and Villejuif, FranceSee the 16 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?
Source: NCT06890598, who can take part
Where in France
- Hopital AvicenneBobigny, FranceNot yet recruiting
- Hospices Civils de Lyon - Hopital Louis PradelBron, FranceTaking people
- Chu Grenoble AlpesLa Tronche, FranceTaking people
- Centre Leon BerardLyon Cedex08, FranceTaking people
- Assistance Publique Hôpitaux de Marseille - Hôpital NordMarseille, FranceTaking people
- Centre Antoine LacassagneNice, FranceTaking people
- Groupe hospitalier Paris saint JosephParis, FranceTaking people
- Hôpital Européen Georges PompidouParis, FranceTaking people
- Institut CurieParis, FranceTaking people
- CHU Bordeaux Haut-LevequePessac, FranceTaking people
- Centre Hospitalier Universitaire de PoitiersPoitiers, FranceTaking people
- Institut Jean GodinotReims, FranceTaking people
- Centre Hospitalier Universitaire de Rennes - Hôpital PontchaillouRennes, FranceTaking people
- CHU de Toulouse - Hopital LarreyToulouse, FranceTaking people
- Hopital Robert SchumanVantoux, FranceTaking people
- Gustave RoussyVillejuif, FranceTaking 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
- NCT06890598EU 2024-512302-25-00
- Record updated
- 4 November 2026
- Original description
The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.Read full original descriptionShow less
A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02
The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.
Inclusion: Histological or cytological confirmation of NSCLC; Part A; Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible; Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection; Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy; Must have disease with evidence of KRAS G12C mutation; Must have known programmed death-ligand 1 (PD-L1) expression; Must have an ECOG performance status of 0 or 1; Able to swallow oral medication; 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: Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy; Have another type of cancer that is progressing or required active treatment within the past 2 years before screening; Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed; Have known, actionable changes in the EGFR or ALK genes.