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
This study is investigating a new treatment approach for people who have advanced bowel cancer (metastatic colorectal cancer) with a specific genetic change in their cancer, known as a KRAS p.G12C mutation. Participants have not yet received treatment for their advanced cancer. The study aims to compare how effective a new combination of medications (sotorasib, panitumumab, and FOLFIRI) is against the standard treatment (FOLFIRI, with or without bevacizumab). Researchers want to see if the new combination can prevent the cancer from growing for longer. This is a Phase 3 study, meaning it's a large trial to confirm if the new treatment is better than existing options and if it's safe.
At a glance
What is this study about?
This study is looking at advanced bowel cancer, which means the cancer has spread from where it started to other parts of the body. Doctors often call this 'metastatic colorectal cancer'. Researchers are focusing on a particular type of this cancer where the cancer cells have a specific change in their DNA, known as a KRAS p.G12C mutation. This mutation can affect how the cancer grows and responds to treatment. The main goal of this study is to find out if a new combination of treatments works better than current standard treatments for these patients.
The study will compare two main treatment approaches. One group of patients will receive a combination of three drugs: sotorasib, panitumumab, and FOLFIRI. FOLFIRI is a common chemotherapy treatment for bowel cancer. The other group will receive FOLFIRI, possibly with another drug called bevacizumab, which is also a standard treatment. By comparing these two groups, doctors hope to learn if the new combination of drugs can stop the cancer from growing for a longer period. This is important because it could offer a new and more effective treatment option for people with this specific type of bowel cancer.
This is a Phase 3 study, which means it's one of the final steps in testing a new treatment before it can become widely available. In this phase, a larger number of patients are involved to get a clear picture of how well a treatment works and its safety compared to existing options. The results from this study could help improve future care for people living with advanced bowel cancer that has the KRAS p.G12C mutation.
Key takeaways
- This study is for advanced bowel cancer with a specific KRAS p.G12C gene change.
- It compares a new combination of treatments to standard care.
- The goal is to see if the new treatment can stop cancer growth for longer.
- Participation involves regular hospital visits for treatment and monitoring.
- Expected to involve a large number of participants to confirm treatment benefits and safety.
- Results could lead to improved treatments for this type of cancer.
Who may be eligible?
To join this study, you need to have bowel cancer that has spread to other parts of your body, and your cancer must have a specific genetic change called a KRAS p.G12C mutation. This mutation needs to be confirmed by tests. You also need to be generally well enough to take part, meaning you can mostly look after yourself and have healthy organ function. Your cancer also needs to be 'measurable', which means doctors can clearly see and track its size using scans.
There are certain reasons why you might not be able to join. For example, if your cancer has spread to your brain and hasn't been treated, or if it involves the lining of your brain and spinal cord, you wouldn't be eligible. Also, if you've already had a specific type of treatment for your KRAS p.G12C mutation, or if you have certain lung conditions like scarring or inflammation, you wouldn't be able to participate. These rules are in place to ensure the safety of participants and to make sure the study results are clear and reliable.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have bowel cancer that has spread?
- Has my cancer been tested and confirmed to have the KRAS p.G12C gene change?
- Have I started any treatment for my advanced cancer yet?
- Am I generally well and able to carry out most daily activities?
- Do I have any untreated cancer that has spread to my brain or surrounding areas?
- Have I had any previous treatment for a KRAS p.G12C mutation?
What does participation involve?
If you decide to take part in this study, you would receive one of the treatment combinations being tested. This would involve regular visits to the hospital for your medication, which might be given through a drip (intravenously) or as tablets. You would have regular assessments, such as blood tests, scans (like CT scans) to check your cancer, and check-ups with the study doctors and nurses. These visits and tests are to monitor your health, how you're responding to the treatment, and to check for any side effects. You'll be closely followed throughout the treatment period and for some time afterwards, to track your progress and long-term health. The total duration of your participation will depend on how you respond to the treatment, but ongoing follow-up ensures your well-being is monitored.
Potential risks and benefits
Locations (286)
- Ironwood Cancer and Research Centers ScottsdaleVerified postcodeChandler, United States· Recruiting
- Providence Saint Jude Medical CenterVerified postcodeFullerton, United States· Recruiting
- City of Hope National Medical CenterVerified postcodeLong Beach, United States· Recruiting
- Cancer and Blood Research Center, LLCVerified postcodeLos Alamitos, United States· Recruiting
- California Research InstituteVerified postcodeLos Angeles, United States· Recruiting
- Norwalk HospitalVerified postcodeNorwalk, United States· Terminated
- Cancer Specialists of North Florida - SouthpointVerified postcodeJacksonville, United States· Recruiting
- D and H Cancer Research CenterVerified postcodeMargate, United States· Recruiting
- Mid Florida Hematology and Oncology Centers PAVerified postcodeOrange City, United States· Terminated
- Boca Raton Clinical Research Medical Center IncVerified postcodePlantation, United States· Terminated
- Georgia Cancer SpecialistsVerified postcodeAtlanta, United States· Recruiting
- Insight Research InstituteVerified postcodeChicago, United States· Recruiting
Common questions
What is a KRAS p.G12C mutation?
It's a specific change in the DNA of your cancer cells that can influence how the cancer behaves and responds to certain treatments.
What does 'metastatic' mean?
It means the cancer has spread from the original site (bowel) to other parts of the body.
What are FOLFIRI, sotorasib, panitumumab, and bevacizumab-awwb?
These are different medications used to treat cancer. FOLFIRI is a type of chemotherapy, while sotorasib, panitumumab, and bevacizumab-awwb are targeted therapies that work in specific ways against cancer cells.
Will I know which treatment I'm getting?
In many clinical trials like this, participants are randomly assigned to a treatment group, and often neither you nor your doctor will know which specific treatment you are receiving (this is called 'blinding') until the study is over.
What is a 'Phase 3' study?
Phase 3 is a large study that compares a new treatment to existing standard treatments to see if it's better and safe enough to be used more widely.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
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