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)
Key facts
- Where
- Budapest VIII, Budapest XII, Debrecen, Gyula, Kaposvár, Nyíregyháza és Szolnok, MagyarországSee the 7 sites
- Phase
- 3. fázis
Could this be for you?
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 Magyarország
- Semmelweis UniversityBudapest VIII, MagyarországTaking people
- Orszagos Onkologiai IntezetBudapest XII, MagyarországTaking people
- University of DebrecenDebrecen, MagyarországTaking people
- Bekes Varmegyei Koezponti KorhazGyula, MagyarországTaking people
- Somogy Vármegyei Kaposi Mór Oktató KórházKaposvár, MagyarországTaking people
- Szabolcs Szatmár Bereg Vármegyei OktatókórházNyíregyháza, MagyarországTaking people
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-RendelointézetSzolnok, MagyarországTaking people
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
- Amgen Inc.
- Trial code
- EU 2022-502352-31-00
- Record updated
- 2026. július 30.
- Original description
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 armRead full original descriptionShow less
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)
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
Inclusion: 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.
Exclusion: 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.