NCT06890598Recruiting
Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
Summary
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 criteria
• Histological or cytological confirmation of NSCLC. • Part A 1. 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. 2. 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 criteria
• Have known, actionable changes in the EGFR or ALK genes. • 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. • 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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Australia, Belgium, Brazil, Chile, China, Czechia, Greece, Hungary, India, Israel, Japan, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
- Sponsor
- Eli Lilly and Company(Industry)
- Protocol no.
- 18763
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Drug
Treatments studied
- Olomorasib
- Pembrolizumab
- Durvalumab
- Placebo
Collaborators
AstraZeneca
Locations · 345
- Baden, SwitzerlandKantonsspital BadenRecruiting at this site
- Fribourg, SwitzerlandHFR Fribourg - Hôpital CantonalRecruiting at this site
- Locarno, SwitzerlandKouros Moccia OncologiaRecruiting at this site
- Bron, FranceHospices Civils de Lyon - Hopital Louis PradelRecruiting at this site
- La Tronche, FranceChu Grenoble AlpesRecruiting at this site
- Lyon Cedex08, FranceCentre Leon BerardRecruiting at this site
- Marseille, FranceAssistance Publique Hôpitaux de Marseille - Hôpital NordRecruiting at this site
- Nice, FranceCentre Antoine-LacassagneRecruiting at this site
- Paris, FranceGroupe hospitalier Paris saint JosephRecruiting at this site
- Paris, FranceHôpital Européen Georges PompidouRecruiting at this site
- Paris, FranceInstitut CurieRecruiting at this site
- Pessac, FranceCHU Bordeaux Haut-LevequeRecruiting at this site
- Poitiers, FranceCentre Hospitalier Universitaire de PoitiersRecruiting at this site
- Reims, FranceInstitut Jean GodinotRecruiting at this site
- Rennes, FranceCentre Hospitalier Universitaire de Rennes - Hôpital PontchaillouRecruiting at this site
- Toulouse, FranceCHU de Toulouse - Hopital LarreyRecruiting at this site
- Vantoux, FranceHôpital Robert SchumanRecruiting at this site
- Villejuif, FranceGustave RoussyRecruiting at this site
- Berlin, GermanyVivantes Klinikum im Friedrichshain - Landsberger AlleeRecruiting at this site
- Berlin, GermanyEvangelische Lungenklinik BerlinRecruiting at this site
- Berlin, GermanyDRK Kliniken Berlin MitteRecruiting at this site
- Chemnitz, GermanyKlinikum ChemnitzRecruiting at this site
- Cologne, GermanyMV-Zentrum für Onkologie und HämatologieRecruiting at this site
- Erfurt, GermanyHELIOS Klinikum ErfurtRecruiting at this site
- Gauting, GermanyAsklepios Fachkliniken München-GautingRecruiting at this site
- Georgsmarienhütte, GermanyFranziskus-Hospital HarderbergRecruiting at this site
- Großhansdorf, GermanyLungenClinic GrosshansdorfRecruiting at this site
- Halle, GermanyKrankenhaus Martha-Maria Halle-DölauRecruiting at this site
- Hamburg, GermanyAsklepios Klinik HarburgRecruiting at this site
- Heidelberg, GermanyThoraxklinik-Heidelberg gGmbHRecruiting at this site
In total, worldwide, 345 of the 366 sites listed in the registry are recruiting; the other 21 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 7, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 315 more locations
Other identifiers
- 2024-512302-25-00 · CTIS number
- J3M-MC-JZQH · other identifier
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.