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
- Changhua County, Chiayi City, Douliu, Hualien City, Kaohsiung City, Kaohsiung Niao Sung Dist, New Taipei City, Taichung, Tainan, Taipei, and Taoyuan, TaiwanSee the 19 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 Taiwan
- Changhua Christian HospitalChanghua County, TaiwanTaking people
- Buddhist Dalin Tzu Chi General HospitalChiayi City, TaiwanTaking people
- National Taiwan University Hospital Yun-Lin Branch Dou-Liou RegionDouliu, TaiwanTaking people
- Hualien Tzu Chi Medical CenterHualien City, TaiwanTaking people
- E-DA HospitalKaohsiung City, TaiwanTaking people
- Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, TaiwanTaking people
- Chang Gung Memorial Hospital at KaohsiungKaohsiung Niao Sung Dist, TaiwanTaking people
- Far Eastern Memorial HospitalNew Taipei City, TaiwanTaking people
- New Taipei Municipal TuCheng HospitalNew Taipei City, TaiwanTaking people
- Chung Shan Medical University HospitalTaichung, TaiwanTaking people
- Taichung Veterans General HospitalTaichung, TaiwanTaking people
- Chi Mei Hospital - Liouying BranchTainan, TaiwanTaking people
- Chi Mei Medical CenterTainan, TaiwanTaking people
- National Cheng Kung University HospitalTainan, TaiwanTaking people
- National Taiwan University Cancer Center (NTUCC)Taipei, TaiwanTaking people
- National Taiwan University HospitalTaipei, TaiwanTaking people
- Taipei Medical University HospitalTaipei, TaiwanNot yet recruiting
- Taipei Veterans General HospitalTaipei, TaiwanTaking people
- Chang Gung Medical Foundation-Linkou BranchTaoyuan, TaiwanTaking 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.