Tests sotorasib with panitumumab and FOLFIRI in colorectal cancer
Compares sotorasib combination treatment with FOLFIRI in adults with KRAS-mutated colorectal cancer.
Key facts
- Who runs it
- Amgen
- Where
- Budapest, Debrecen, Gyula, Kaposvár, Nyíregyháza, and Szolnok, HungarySee the 7 sitesAlso in 34 other countries, 284 sites
- Trial code
- Registry title
- Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 450 people, planned
- Started
- 17 Jul 2024
- Expected to end
- 25 Apr 2032
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- FOLFIRI Regimen
- Sotorasib
- Panitumumab
- Bevacizumab-awwb
- Record updated
- 3 September 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 gene change, who have not had treatment for it before.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Colorectal adenocarcinoma that has spread (metastatic), confirmed by a pathology report, with disease that can be measured on scans (RECIST v1.1).
- Earlier treatment
- The trial is for people who have not been treated before (treatment-naïve). People who had a KRAS p.G12C inhibitor cannot join.
- Biomarker or test result
- KRAS p.G12C mutation, found by a locally validated test and confirmed by a central laboratory.
Main reasons for not taking part
- Active brain metastases that have not been treated
- Leptomeningeal disease
- Earlier treatment with a KRAS p.G12C inhibitor
- History or signs of interstitial pneumonitis or pulmonary fibrosis on the baseline CT scan
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay
- Central laboratory detection of KRAS p.G12C mutation
- Measurable metastatic disease per RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
- Adequate organ function
Who cannot take part
- Previous treatment with a KRAS p.G12C inhibitor
- 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.
- 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 Hungary
Also in 34 other countries, 284 sites
- Orszagos Onkologiai IntezetBudapest, HungaryTaking people
- Semmelweis EgyetemBudapest, HungaryTaking people
- Debreceni Egyetem Klinikai KozpontDebrecen, HungaryTaking people
- Békés Vármegyei Központi Kórház Pándy Kálmán TagkórházGyula, HungaryTaking people
- Somogy Vármegyei Kaposi Mór Oktató KórházKaposvár, HungaryTaking people
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras TagkorhazNyíregyháza, HungaryNo longer taking part
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-RendelointézetSzolnok, HungaryTaking people
About the trial
What the trial wants to find out
The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.
The 2 groups in the trial
- Arm A: Sotorasib + Panitumumab + FOLFIRITreatment being tested
Sotorasib will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion.
Treatment: FOLFIRI Regimen, Sotorasib, and Panitumumab
- Arm B: FOLFIRI with or Without Bevacizumab-awwbExisting treatment, for comparison
Participants will receive FOLFIRI Q2W with or without bevacizumab-awwb.
Treatment: FOLFIRI Regimen and Bevacizumab-awwb
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.
- 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 panitumumab and FOLFIRI in colorectal 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 NCT06252649, who can take part
- Record updated
- 3 September 2026