Tests olomorasib with immunotherapy for KRAS G12C lung cancer
Tests olomorasib with immunotherapy in adults with KRAS G12C non-small cell lung cancer.
Key facts
- Who runs it
- Eli Lilly and Company
- Where
- Bari, Catania, Genova, Meldola, Milan, Monza, Naples, Orbassano, Rome, and Verona, ItalySee the 10 sitesAlso in 28 other countries, 355 sites
- Trial code
- 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
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 700 people, planned
- Started
- 27 Mar 2025
- Expected to end
- Feb 2032
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Olomorasib
- Pembrolizumab
- Durvalumab
- Placebo
- Record updated
- 4 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with KRAS G12C-mutant non-small cell lung cancer, either after surgery (Part A) or not removable by surgery (Part B).
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Part A: stage II-IIIB after surgery. If chemo-immunotherapy was given before surgery, some tumor must remain; no complete response. Part B: stage III cancer that cannot be removed by surgery and has not grown during chemoradiotherapy.
- Earlier treatment
- Part A: chemo-immunotherapy before surgery, or surgery first. Part B: platinum-based chemoradiotherapy given at the same time, with no growth of the cancer.
- Biomarker or test result
- KRAS G12C mutation in the tumor. PD-L1 level must be known.
Main reasons for not taking part
- Known EGFR or ALK gene changes that can be treated with targeted drugs
- Another cancer that is growing or needed treatment in the past 2 years
- Autoimmune disease needing treatment of the whole body in the past 2 years
- Serious (Grade 3 or higher) side effect or allergic reaction from earlier immunotherapy
- Breastfeeding during treatment
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Italy
Also in 28 other countries, 355 sites
- Instituto Tumori Giovanni Paolo IIBari, ItalyContact: Domenico Galetta (principal investigator)Taking people
- Policlinico "G. Rodolico"Catania, ItalyContact: HECTOR SOTO PARRA (principal investigator)Taking people
- Ospedale San MartinoGenova, ItalyContact: Carlo Genova (principal investigator)Taking people
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriMeldola, ItalyContact: Angelo Delmonte (principal investigator)Taking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyContact: Diego Signorelli (principal investigator)Taking people
- Ospedale San Gerardo - ASST MonzaMonza, ItalyContact: Diego Cortinovis (principal investigator)Taking people
- Azienda Ospedaliera dei ColliNaples, ItalyContact: Danilo Rocco (principal investigator)Taking people
- Azienda Sanitaria Ospedaliera S Luigi GonzagaOrbassano, ItalyContact: Silvia Novello (principal investigator)Taking people
- Istituto Nazionale Tumori Regina ElenaRome, ItalyContact: Lorenza Landi (principal investigator)Taking people
- Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo TrentoVerona, ItalyContact: SARA PILOTTO (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Part A: Olomorasib + PembrolizumabTreatment being tested
Participants will receive olomorasib administered orally in combination with pembrolizumab intravenously (IV) for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.
Treatment: Olomorasib and Pembrolizumab
- Part A: Placebo + PembrolizumabPlacebo, for comparison
Participants will receive placebo administered orally in combination with pembrolizumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.
Treatment: Pembrolizumab and Placebo
- Part B: Olomorasib + DurvalumabTreatment being tested
Participants will receive olomorasib administered orally in combination with durvalumab administered IV for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.
Treatment: Olomorasib and Durvalumab
- Part B: Placebo + DurvalumabPlacebo, for comparison
Participants will receive placebo administered orally in combination with durvalumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.
Treatment: Durvalumab and Placebo
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Tests olomorasib with immunotherapy for KRAS G12C lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06890598, who can take part
- Publications
- SUNRAY-02: a study of olomorasib combined with immunotherapy in stage II-III KRAS G12C-mutant non-small cell lung cancer after definitive therapy.Future oncology (London, England), 2026
- Record updated
- 4 November 2026