Tests sotorasib with panitumumab and FOLFIRI in colorectal cancer
Compares sotorasib combination treatment with FOLFIRI in adults with KRAS-mutated colorectal cancer.
Plain-language title generated from the registry record
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
Key facts
- Where
- Akashi-shi, Bunkyo Ku, Bunkyo-ku, Chiba, Chuo Ku, Fukuoka, Hirakata-shi, Kashiwa-shi, Kawasaki-shi, Kitaadachi-gun, Koto-ku, Matsuyama, Nagoya, Niigata, Osaka, Sapporo, Suita-shi, Sunto-gun, Tokushima, and Yokohama, JapanSee the 21 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT06252649, who can take part
Where in Japan
- Hyogo Cancer CenterAkashi-shi, JapanTaking people
- Tokyo Metropolitan Komagome HospitalBunkyo Ku, JapanTaking people
- Nippon Medical School HospitalBunkyo-ku, JapanTaking people
- Chiba Cancer CenterChiba, JapanTaking people
- National Cancer Center HospitalChuo Ku, JapanTaking people
- National Hospital Organization Kyushu Cancer CenterFukuoka, JapanTaking people
- Kansai Medical University HospitalHirakata-shi, JapanTaking people
- National Cancer Center Hospital EastKashiwa-shi, JapanTaking people
- St. Marianna University HospitalKawasaki-shi, JapanTaking people
- Saitama Cancer CenterKitaadachi-gun, JapanTaking people
- The Cancer Institute Hospital of Japanese Foundation for Cancer ResearchKoto-ku, JapanTaking people
- National Hospital Organization Shikoku Cancer CenterMatsuyama, JapanTaking people
- Aichi Cancer CenterNagoya, JapanTaking people
- Niigata Cancer Center HospitalNiigata, JapanTaking people
- National Hospital Organization Osaka National HospitalOsaka, JapanTaking people
- Hokkaido University HospitalSapporo, JapanTaking people
- The University of Osaka HospitalSuita-shi, JapanTaking people
- Shizuoka Cancer CenterSunto-gun, JapanTaking people
- Tokushima University HospitalTokushima, JapanTaking people
- Kanagawa Prefectural Hospital Organization Kanagawa Cancer CenterYokohama, JapanTaking people
- Yokohama City University Medical CenterYokohama, JapanTaking 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
- Trial code
- NCT06252649
- Record updated
- 3 September 2026
- Original description
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.Read 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)
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.
Inclusion: 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.
Exclusion: 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.