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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)
EU CTIS ID: 2022-502352-31-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Active, untreated brain metastases
- Leptomeningeal disease
- 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
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan
See the full eligibility criteria
- 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
- Active, untreated brain metastases
- Leptomeningeal disease
- 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
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- United Kingdom
- Brazil
- Chile
- Thailand
- Japan
- Turkey
- Taiwan
- Canada
- Australia
- Argentina
- Mexico
- United States
- Hong Kong
- Switzerland
- Colombia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; United Kingdom; Brazil; Chile; Thailand; Japan and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.