Colorectal NeoplasmsPhase 2NCT07814417
A Study of Olomorasib (LY3537982) in Participants With Advanced Colorectal Cancer and a KRAS G12C Mutation
A Phase 2 study testing Olomorasib, Cetuximab and Oxaliplatin in people with Colorectal Neoplasms, run by Eli Lilly and Company at 18 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Olomorasib, Cetuximab and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Oct 2026to Nov 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Have active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.
- Have a clinically significant active malabsorption syndrome or other conditions likely to affect gastrointestinal absorption of the orally administered study treatments.
- Have known untreated active central nervous system metastases or carcinomatous meningitis.
- 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.
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- Have human immunodeficiency virus (HIV) with a history of Kaposi's sarcoma or Multicentric Castleman's Disease.
- 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.
- 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.
- Are pregnant, breastfeeding, or intend to become pregnant during the study.
Trial locations and contacts
18 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
18 sites in 3 countries
United States9 sites
Texas Oncology - Central South
Austin, Texas, 78745
409-899-7180
Vivian Cline
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Alexander Bray
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
617-632-5460
Brandon Huffman
START Astera, LLC
East Brunswick, New Jersey, 08816
732-390-7750
Siu-Long Yao
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Keeran Sampat
Inova Health Care Services
Falls Church, Virginia, 22042
703-776-2109
Raymond Wadlow
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
323-865-3000
Heinz-Josef Lenz
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin, 53792
608-263-9063
Dustin Deming
AdventHealth Orlando
Orlando, Florida, 32803
407-303-5600
Mohamedtaki Tejani
Spain8 sites
Hospital del Mar
Barcelona, 08003
+34 932 48 30 00
Joana Vidal Barrull
Hospital Universitari Quiron Dexeus Barcelona
Barcelona, 08028
+34 935460139
Jose Luis Cuadra
Hospital Universitario Vall d'Hebron
Barcelona, 08035
+34 932543450
Elena Elez
Complejo hospitalario de Jaen
Jaén, 23007
+34 953 00 80 00
Francisco Jose Garcia Verdejo
Clinica Universidad de Navarra - Madrid
Madrid, 28027
Ignacio Matos Garcia
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320
Marta Llanos Muñoz
Hospital Universitario Marques De Valdecilla
Santander, 39008
+34942202520
Carlos López López
Hospital Clinico Universitario de Santiago
Santiago de Compostela, 15706
Yolanda Vidal
About this study
Official title: 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.
- Conditions
- Colorectal Neoplasms
- Being tested
- Olomorasib, Cetuximab, Oxaliplatin, Leucovorin/levofolinate calcium, 5-fluorouracil
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlomorasibDrug
Also called LY3537982
Administered orally
CetuximabDrug
Administered IV
OxaliplatinDrug
Administered IV
Leucovorin/levofolinate calciumDrug
Administered IV
5-fluorouracilDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Olomorasib + Cetuximab + mFOLFOX6 | Experimental | Olomorasib administered orally; Cetuximab, fluorouracil, leucovorin \& oxaliplatin administered intravenously (IV) Receives: Drug: Olomorasib; Drug: Cetuximab; Drug: Oxaliplatin; Drug: Leucovorin/levofolinate calcium; Drug: 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: Baseline until Disease Progression (PD) or Participant Stops Study (Estimated up to 15 Months)
Progression-Free Survival (PFS) Per RECIST v1.1
Measured: Baseline to the Date of First Documented Progression of Disease or Participant Stops Study (Estimated up to 21 Months)
Secondary outcomes (5)
Overall Survival (OS)
Measured: Baseline through End of Study (Estimated up to 21 months)
Duration of Response (DoR)
Measured: Baseline up to 15 months
Disease Control Rate (DCR)
Measured: Baseline up to 15 months
Time to Response (TTR)
Measured: Baseline up to 15 months
Pharmacokinetics (PK): Plasma Concentrations of Olomorasib (LY3537982)
Measured: Baseline up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814417
- Sponsor's protocol ID
- 27858
- Other IDs
- J3M-MC-JZQN, 2026-526138-23-00
- Status last verified
- Oct 2026
- First submitted
- 4 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.