Phase II single arm study with CABozantinib in Non-Small Cell Lung Cancer patients with MET deregulation
This is a research study (Phase II) testing a drug called Cabozantinib for people with non-small cell lung cancer (NSCLC). It focuses on patients whose cancer has certain genetic changes involving a protein called MET. These changes are either 'MET amplification' or 'MET exon 14 skipping mutation'. The study aims to find out how many patients experience their tumours shrinking or disappearing after taking Cabozantinib. This includes people who have or haven't had MET-targeting treatments before. Researchers will also look at how long people live without their cancer getting worse, overall survival, and how many people have their disease under control. They will also collect blood and tissue samples to learn more about the cancer.
At a glance
What is this study about?
This study is about a particular type of lung cancer called non-small cell lung cancer, or NSCLC. This type of cancer is quite common. Researchers are testing a drug called Cabozantinib (you might hear it called CABOMETYX) to see if it can help patients whose NSCLC has specific genetic changes. These changes involve something called the MET protein, and they are either a 'MET amplification' or a 'MET exon 14 skipping mutation'. Knowing about these specific changes can sometimes help doctors choose the best treatment.
Cabozantinib is given as tablets. The main aim of this study is to see how many patients respond to the treatment. A 'response' means that their tumour either shrinks significantly (a partial response) or disappears completely (a complete response). This is important because it tells us if the drug is effective at fighting the cancer cells. The study is open to patients who have either had other treatments for MET problems before or haven't.
Besides looking at how many people respond, the researchers will also be checking other things. These include how long patients live without their cancer getting worse, how long they live overall, and how many patients have their disease kept stable for a period of time. They will also collect blood and tissue samples to look for 'biomarkers', which are things in the body that can give clues about how the cancer behaves and how it might respond to treatment. This information could help doctors in the future to better understand and treat NSCLC.
Key takeaways
- The study is investigating Cabozantinib for non-small cell lung cancer.
- It targets patients with specific MET genetic changes in their cancer.
- The main goal is to see how many patients respond to the drug (tumour shrinkage).
- It's a Phase II study, focusing on how well the treatment works.
- Participation involves taking tablets and regular hospital visits for monitoring.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old. The study is open to both men and women.
Crucially, you must have non-small cell lung cancer (NSCLC) that shows specific changes related to a protein called MET. Your doctors will be able to test for these changes – they are either 'MET amplification' or 'MET exon 14 skipping mutation'.
There will be other detailed criteria that your doctors will check, such as your general health, how well your organs are working, and if you have other medical conditions. These are standard checks to make sure the study medication is safe for you and that the results of the study are clear.
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 non-small cell lung cancer?
- Has your doctor told you your cancer has 'MET amplification' or 'MET exon 14 skipping mutation'?
- Are you able to take medication by mouth (tablets)?
- Are you generally well enough for a clinical trial?
What does participation involve?
If you decide to take part in this study, you'll be given Cabozantinib tablets to take. These come in different strengths (20mg, 40mg, or 60mg), and your study doctor will decide the right dose for you. You'll have regular visits to the hospital for checks and assessments. These visits will involve physical examinations, blood tests, and scans to see how your cancer is responding to the treatment. You'll be closely monitored for any side effects of the medication.
The study will continue as long as the treatment is helping you and you are tolerating it well. If your cancer starts to get worse or if you experience severe side effects, you might stop taking the study drug. At some point during the study, if your cancer progresses, you might be asked to provide an additional tissue sample, if you agree. The total duration of your participation will depend on how you respond to the treatment and the study follow-up plan.
Potential risks and benefits
Locations (1)
- —UnverifiedItaly
Common questions
What is Cabozantinib?
Cabozantinib is a drug being tested for non-small cell lung cancer, especially for patients whose cancer has specific changes related to the MET protein.
What does 'MET deregulation' mean?
It means there are specific genetic changes in your cancer (either 'MET amplification' or 'MET exon 14 skipping mutation') that affect how a protein called MET works.
What is a Phase II study?
A Phase II study means the drug has already passed initial safety tests and researchers are now looking to see how well it works and to further assess its safety in a larger group of people with the specific condition.
Will I get Cabozantinib or a placebo?
This is a 'single arm' study, meaning all participants who are enrolled and meet the criteria will receive Cabozantinib. There is no placebo group.
What happens if I want to stop taking part?
You are free to leave the study at any time, for any reason, without it affecting the care you receive from your doctors.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.