A Phase 3 Multicenter, Randomized, Openlabel, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator’s Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects with KRAS p.G12C Mutation
This research is a 'Phase 3' study, which means it's testing new treatments that have already shown promise. It's for people with bowel cancer that has spread to other parts of the body (metastatic) and has a particular genetic mutation called KRAS p.G12C. Participants will receive either a new combination of medicines, sotorasib and panitumumab, or one of the standard treatments already used for this type of cancer (trifluridine and tipiracil, or regorafenib). The main goal is to see how long people live without their cancer growing (progression-free survival) and to understand how safe each treatment is. Researchers also want to know how the treatments affect overall survival and quality of life.
At a glance
What is this study about?
This study is a clinical trial for people living with advanced bowel cancer. Specifically, it's for those whose cancer has spread to other parts of the body (this is called metastatic colorectal cancer) and has a particular fault in its genes, known as a KRAS p.G12C mutation. This gene fault can make the cancer harder to treat with some standard therapies, so researchers are always looking for new approaches.
The trial aims to compare two different ways of treating this cancer. One group of patients will receive a new combination of medicines: sotorasib and panitumumab. The other group will receive one of the standard treatments that doctors might choose for them, either trifluridine and tipiracil (also known as Lonsurf) or regorafenib (also known as Stivarga). Panitumumab is also known as Vectibix. The researchers want to find out if the new combination works better than the standard options.
The main thing the study will measure is how long patients live without their cancer getting worse, which doctors call 'progression-free survival'. They will also look at how long people live overall, how much the cancer shrinks, and importantly, what side effects people experience with each treatment. The study also investigates how these treatments affect a person's general well-being and quality of life.
Key takeaways
- This study evaluates new treatments for advanced bowel cancer with a specific gene change (KRAS p.G12C).
- It compares a new drug combination against current standard treatments.
- The main aim is to see which treatment best prevents cancer growth and is safest.
- Quality of life and overall survival are also important factors being studied.
- You would receive close medical monitoring throughout the trial.
Who may be eligible?
To join this study, people need to be at least 18 years old. Both men and women can take part. A key requirement is that a person must have bowel cancer that has spread to other parts of their body, and it must have a specific genetic change called a KRAS p.G12C mutation. Your doctor would likely have tested for this when your cancer was diagnosed or when it progressed.
Also, participants would need to have already tried at least one other treatment for their advanced bowel cancer, and that treatment would not have fully stopped the cancer from growing. This study is not for people who are newly diagnosed with advanced bowel cancer, but rather for those whose cancer has continued to progress despite previous treatments.
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.
- Are you 18 years old or older?
- Do you have bowel cancer that has spread?
- Has your doctor confirmed your cancer has the KRAS p.G12C gene mutation?
- Have you already received other treatments for your advanced bowel cancer?
What does participation involve?
Taking part in this study would involve regular hospital visits. You would be given either the new combination of medicines (sotorasib and panitumumab) or one of the standard treatments. These medicines might be taken as tablets or given through a drip (infusion), depending on the specific drug. You would have examinations, blood tests, and scans regularly to check how the treatment is working and to monitor for any side effects. You might also be asked to complete questionnaires about how you are feeling and your quality of life. The total duration of your participation would depend on how your cancer responds to the treatment, but you would continue to be monitored for some time even after stopping the study drugs.
Potential risks and benefits
Locations (5)
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedGreece
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
What is a 'Phase 3' study?
Phase 3 means this is a major trial comparing a promising new treatment with a standard one, hoping to show it's better or safer.
What does 'metastatic' colorectal cancer mean?
It means the bowel cancer has spread from where it started to other parts of your body.
What is a 'KRAS p.G12C mutation'?
It's a specific change in the genes of the cancer cells that doctors can test for, which can help guide treatment choices.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, meaning both you and your doctor will know which treatment you are receiving.
What if I experience side effects?
The study team will closely monitor you and provide care for any side effects you might experience during the trial.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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