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Taking peoplePhase 3

Tests sotorasib with chemotherapy in adults with colorectal cancer carrying a KRAS G12C mutation

Tests sotorasib with chemotherapy in adults with metastatic colorectal cancer carrying KRAS G12C.

Key facts

Who runs it
Amgen Inc.
Where
Tallinn, EstoniaSee the siteAlso in 17 other countries, 145 sites
Trial code
Registry title
Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
Status
Recruiting
Phase
Phase 3
People taking part
241 people, planned
Started
10 Feb 2025
Expected to end
31 Aug 2031
Type of study
Interventional
Record updated
30 July 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 colorectal cancer that has spread and has a KRAS p.G12C change, who have not had treatment before.

Age
18 to 64 years (or the legal adult age in the country, if higher than 18).
Sex
All sexes can join.
Disease stage
Colorectal adenocarcinoma that has spread (metastatic) and can be measured on scans (RECIST v1.1). Old radiated lesions count only if they grew after radiation.
Earlier treatment
No treatment before for the spread cancer (treatment-naïve). No earlier KRAS p.G12C inhibitor.
Biomarker or test result
KRAS p.G12C mutation, confirmed by a central laboratory.

Main reasons for not taking part

  • Brain metastases that are active and untreated
  • Leptomeningeal disease
  • Earlier treatment with a KRAS p.G12C inhibitor
  • Past dose reduction or delay of 5-fluorouracil (5-FU) or irinotecan because of side effects
  • Interstitial pneumonitis or pulmonary fibrosis, now or in the past

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Pathologically documented metastatic colorectal adenocarcinoma
  • Central confirmation of KRAS p.G12C mutation
  • Measurable disease per RECIST v1.1 criteria. Lesions previously radiated are not considered measurable unless they have progressed after radiation
  • Age ≥ 18 years (or ≥ legal age within the country if it is more than 18 years)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
  • Life expectancy of > 6 months, in the opinion of the investigator
  • Adequate hematologic and end organ function
  • Ability to take oral medications and willing to record daily adherence to investigational product
  • Central laboratory detection of KRAS p.G12C mutation

Who cannot take part

  • Previous treatment with a KRAS p.G12C inhibitor
  • Subject has required a dose reduction or dose delay of either 5-fluorouracil (5-FU) or irinotecan in any prior chemotherapy regimen in the past for toxicity, to the investigator's knowledge
  • Leptomeningeal disease
  • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan
  • Active, untreated brain metastases

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 64 years old?
  • How many different drug treatment plans (such as chemotherapy) have you had for cancer that has spread?
  • Has a test of your tumour shown a change (mutation) in the KRAS, NRAS or BRAF genes?
  • Do you have now, or have you ever had, a lung disease with scarring or swelling of the lungs, such as pulmonary fibrosis (scarring of the lungs) or pneumonitis?

Where in Estonia

Also in 17 other countries, 145 sites

  • North Estonia Medical Centre FoundationTallinn, EstoniaNo longer taking part

About the trial

What the trial wants to find out

To compare progression free survival (PFS) in treatment-naïve subjects with KRAS p.G12C mutated metastaticcolorectal cancer (mCRC) between the experimental arm and the control arm

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
Plain-language title
Tests sotorasib with chemotherapy in adults with colorectal cancer carrying a KRAS G12C mutationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2022-502352-31-00, who can take part
Record updated
30 July 2026