A Phase II, single-arm trial to investigate tepotinib in advanced (locally advanced or metastatic) non-small cell lung cancer with MET exon 14 (METex14) skipping alterations or MET amplification (VISION)
This research study, called VISION, is investigating a new drug named tepotinib for people with advanced non-small cell lung cancer. This refers to lung cancer that has spread or is difficult to remove with surgery. The study specifically includes patients whose cancer cells show particular genetic changes called 'MET exon 14 skipping alterations' or 'MET amplification'. The main goal is to find out how effectively tepotinib can shrink tumours in these patients. It also looks at other important things like how long the treatment works, overall survival, and any side effects. This is a Phase II study, meaning it’s an early stage of testing to see if the drug is effective and safe enough to be studied further.
At a glance
What is this study about?
This research study, called VISION, is investigating a new medicine called tepotinib for people with a type of lung cancer known as non-small cell lung cancer. This particular study is for people whose cancer is considered advanced, meaning it has either started to spread to other parts of the body (metastatic) or is very large and difficult to treat locally.
The important thing about this study is that it's only for people whose lung cancer has specific changes in their cancer cells. These changes are called 'MET exon 14 skipping alterations' or 'MET amplification'. Researchers believe that tepotinib might work best against cancer cells that have these particular features.
The main aim of this study is to see how well tepotinib can shrink the tumours in people with these specific types of non-small cell lung cancer. The study will also look at how long the treatment works, how safe it is, and what effects it might have on a person's general health and quality of life. This information helps doctors understand if tepotinib could be a good treatment option for these patients in the future.
Key takeaways
- Tests a new medicine (tepotinib) for advanced non-small cell lung cancer.
- Only for cancers with specific 'METex14 skipping' or 'MET amplification' changes.
- Aims to see how well the medicine shrinks tumours.
- Involves regular health checks and monitoring.
- Participation is voluntary and you can withdraw at any time.
- It's a Phase II study, meaning it's an early look at effectiveness and safety.
Who may be eligible?
To be considered for this study, you would need to be at least 18 years old. There is no upper age limit, meaning older adults can also take part.
Critically, your lung cancer must be non-small cell lung cancer, and it needs to be either locally advanced (meaning it has grown quite large or spread to nearby areas) or metastatic (meaning it has spread to other parts of the body).
Most importantly, your cancer cells must have a specific genetic change. This change is either 'MET exon 14 skipping alterations' or 'MET amplification'. Your doctor would be able to do tests to check for these specific markers in your cancer cells.
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 lung cancer been described as advanced (locally advanced or metastatic)?
- Have tests shown that your cancer cells have 'MET exon 14 skipping' or 'MET amplification'?
What does participation involve?
If you join this study, you will be given the medicine tepotinib. The study doctors and nurses will regularly check your health to see how you are responding to the treatment and to monitor for any side effects. These checks will include blood tests, scans to see the size of your tumours, and physical examinations. You will also be asked about how you are feeling and your quality of life.
Throughout the study, your medical team will carefully track your progress. This will involve regular visits to the clinic for assessments. The total duration of your participation in the study will depend on how you respond to the treatment and the study's follow-up plan, but the team will explain this in detail before you decide to take part.
Potential risks and benefits
Locations (7)
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedPoland
- —UnverifiedItaly
- —UnverifiedNetherlands
- —UnverifiedSpain
- —UnverifiedGermany
Common questions
What kind of lung cancer is this study for?
This study is for a type of lung cancer called non-small cell lung cancer that is advanced (has spread or is large) and has specific gene changes called 'MET exon 14 skipping' or 'MET amplification'.
What is tepotinib?
Tepotinib is the new medicine being tested in this study. Researchers are hoping it can help shrink tumours in people with particular types of advanced lung cancer.
What does 'Phase II' mean?
Phase II is an early stage of testing a new medicine. It means the study is mainly looking at whether the medicine works and is safe enough to be studied further in a larger group of people.
Will I receive regular check-ups if I join?
Yes, if you join the study, you will have regular check-ups, scans, and blood tests to monitor your health, how the treatment is working, and any side effects.
Can I leave the study if I want to?
Yes, you can choose to leave the study at any time, for any reason, and it will not affect your ongoing medical care.
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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