Olomorasib with cetuximab and chemotherapy for advanced colorectal cancer with a KRAS G12C mutation
Tests olomorasib plus other drugs in adults with advanced KRAS G12C colorectal cancer.
Plain-language title generated from the registry record
Registry title: A Study of Olomorasib (LY3537982) in Participants With Advanced Colorectal Cancer and a KRAS G12C Mutation
Key facts
- Where
- Barcelona, Jaén, Madrid, Santa Cruz de Tenerife, Santander, and Santiago de Compostela, SpainSee the 8 sites
- Phase
- Phase 2
Where in Spain
- Hospital del MarBarcelona, SpainNo longer taking part
- Hospital Universitari Quiron Dexeus BarcelonaBarcelona, SpainNo longer taking part
- Hospital Universitario Vall d'HebronBarcelona, SpainNo longer taking part
- Complejo Hospitalario de JaenJaén, SpainNo longer taking part
- Clinica Universidad de Navarra MadridMadrid, SpainNo longer taking part
- Hospital Universitario de CanariasSanta Cruz de Tenerife, SpainNo longer taking part
- Hospital Universitario Marqués de ValdecillaSantander, SpainNo longer taking part
- Hospital Clínico Universitario de SantiagoSantiago de Compostela, SpainNo longer taking part
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
- NCT07814417EU 2026-526138-23-00
- Record updated
- 15 October 2026
- Original description
The main purpose of this study is to evaluate how well olomorasib is tolerated and what side effects may occur when combined with other interventions in participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C-mutant, locally advanced colorectal cancer (CRC) that cannot be removed with surgery or has spread to other parts of the body. Blood tests will be performed to investigate how the body processes the study drug.Read full original descriptionShow less
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Olomorasib in Combination With Cetuximab and mFOLFOX6 in Participants With KRAS G12C-Mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer
The main purpose of this study is to evaluate how well olomorasib is tolerated and what side effects may occur when combined with other interventions in participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C-mutant, locally advanced colorectal cancer (CRC) that cannot be removed with surgery or has spread to other parts of the body. Blood tests will be performed to investigate how the body processes the study drug.
Inclusion: Histologically or cytologically confirmed colorectal cancer (CRC) with Stage III or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy; Must have disease with evidence of KRAS G12C mutation; Have measurable disease per RECIST v1.1; Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Ability to swallow capsules; Have adequate laboratory parameters; Have not received treatment for their CRC that has spread to other parts of the body; 1-2 cycles of FOLFOX prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated.
Exclusion: Have active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease; Have known positive Immunoglobulin E (IgE) antibodies against galactose-α-1,3-galactose (alpha-gal); Have received adjuvant, neoadjuvant, concurrent chemoradiotherapy, or consolidation therapy if treatment was completed less than 6 months prior to enrollment; Have a clinically significant active malabsorption syndrome or other conditions likely to affect gastrointestinal absorption of the orally administered study treatments; Have known additional malignancy that is progressing or has required treatment within the past 2 years; Have uncontrolled, significant cardiovascular disease or cerebrovascular disease; Have an active fungal, bacterial, or active, untreated viral infection; Have human immunodeficiency virus (HIV) with a history of Kaposi's sarcoma or Multicentric Castleman's Disease; Have known untreated active central nervous system metastases or carcinomatous meningitis; Have known B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E gene mutation; Have confirmed Microsatellite Instability-High/deficient Mismatch Repair (MSI-H/dMMR); Individuals with known low or absent dihydropyrimidine dehydrogenase activity; Are pregnant, breastfeeding, or intend to become pregnant during the study.