In our study, participants are randomly divided into groups. This is called randomization. This is important in order to obtain reliable results from the study. Each group receives a different treatment. There are 2 groups in our study:
- Group 1 (treatment arm A) receives sotorasib, panitumumab and FOLFIRI,
- Group 2 (treatment arm B) will receive FOLFIRI with or without bevacizumab-awwb.
If you are assigned to the second group, your doctor will decide in consultation with you whether or not you will receive bevacizumab-awwb.
Aim of the study
This study is being conducted to learn more about the combination therapies of sotorasib, panitumumab and FOLFIRI (irinotecan, leucovorin and 5-fluorouracil [5-FU]) compared to FOLFIRI with or without bevacizumab-awwb in patients with mCRC, who have not previously received systemic therapy for their metastatic disease and have a specific mutation called "Kirsten rat sarcoma viral oncogene homolog" (KRAS) p.G12C.
Who can take part?
Patients with metastatic colorectal carcinoma with KRAS p.G12C mutation (CodeBreaK 301)
Procedure
You will need to attend approximately 15 appointments at the clinic during this study. The appointments take place approximately every 2 weeks and last several hours. Unless otherwise stated, each study phase refers to the first dose of study drug.
Screening phase: Up to 3 appointments.
Treatment phase: on average about 10 to 16 months - 2 appointments per cycle (cycle duration of 28 days).
Safety follow-up: 1 appointment within 30 days (+ 7 days) after the last dose of study treatment or before starting a new cancer therapy.
Long-term follow-up: Every 12 weeks (± 4 weeks) to assess survival and document cancer therapy. You will be followed up for up to 5 years or until you withdraw your consent, "lost to follow-up" or until the study ends prematurely.
Compensation
Original study name
A phase 3 study of sotorasib, panitumumab and FOLFIRI versus FOLFIRI with or without bevacizumab-awwb in treatment-naïve patients with metastatic colorectal cancer with KRAS p.G12C mutation (CodeBreaK 301)
BASEC number
2024-D0035
Sponsors