Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated
This study is looking at a new drug called tepotinib for people with advanced non-small cell lung cancer that has a specific genetic change, known as a MET Exon 14 mutation. Participants will have already received other cancer treatments. The study aims to compare tepotinib with existing standard treatments to see if it's more effective at controlling the cancer's growth and improving quality of life. This research is especially important because there's currently a lack of strong evidence to make new-generation MET-targeting drugs widely available in some countries. By gathering this comparison data, the study hopes to make tepotinib more accessible to patients who could benefit from it, especially since current options are limited for those with this particular type of lung cancer.
At a glance
What is this study about?
This study is looking into a new medication called tepotinib, specifically for people who have advanced non-small cell lung cancer. This type of lung cancer has a particular genetic change, called a 'MET Exon 14 mutation.' Your doctor might have already explained this is a specific target that some newer drugs aim to treat. This study is for people whose cancer has already been treated with at least one other type of therapy, such as chemotherapy or immunotherapy, but the cancer has started to grow again.
The main goal is to see if tepotinib works better than the standard treatments currently available for this situation. Researchers want to find out if it can slow down or stop the cancer from growing for longer, improve how patients feel, and shrink the tumours. This is a "Phase 3" trial, which means it's a large-scale study designed to confirm if a new treatment is truly better than existing ones.
This trial is very important because, in some places, newer drugs like tepotinib aren't easily available for patients with this specific MET Exon 14 mutation, mainly because there hasn't been enough direct comparison data yet. This study is a key opportunity to gather that evidence. If tepotinib proves to be significantly better, it could help make it more widely accessible and offer a valuable new option for patients, especially as current treatment choices can be limited for those with this particular kind of lung cancer.
Key takeaways
- This study compares a new drug, tepotinib, for advanced lung cancer with a specific genetic change (MET Exon 14 mutation).
- It's for people whose cancer has been treated before and has started to grow again.
- The goal is to see if tepotinib works better than standard treatments for controlling cancer growth and improving quality of life.
- Participation could provide access to a promising new treatment option.
- You'll be closely monitored for effectiveness and any side effects.
- You can stop participating in the study at any time.
Who may be eligible?
To be considered for this study, you need to have advanced non-small cell lung cancer that has a specific change called a 'MET Exon 14 mutation.' This mutation must have been confirmed by a test. You also need to have already received at least one course of cancer treatment, like chemotherapy or immunotherapy, and your cancer must have started to grow again.
The study is for adults aged 18 or older. Your general health will also be checked to make sure you're well enough to take part. This includes checks on your kidney and liver function, and blood counts. Even if you have cancer that has spread to your brain, you might still be able to join, as long as any immediate treatment for that has been completed.
There are also some requirements about how many different treatments you've had in the past – generally, no more than two previous types of treatment for your advanced lung cancer. You’ll need to be willing to follow the study schedule, including visits and tests, and provide your written consent to participate.
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 you have advanced non-small cell lung cancer with a MET Exon 14 mutation?
- Has your cancer been treated before, and has it started to grow again?
- Are you aged 18 or older?
- Do you have suitable general health and organ function (e.g., kidneys, liver, blood counts)?
- Are you able to attend regular hospital visits and follow study instructions?
- Have you had no more than two previous treatments for your advanced lung cancer?
What does participation involve?
If you join this study, you will likely receive either the new drug, tepotinib, or one of the standard treatments for your type of advanced lung cancer. This will be decided by chance, like flipping a coin. You'll take the study medication regularly, as instructed by the doctors. You will have regular hospital visits, where doctors will check your health, assess how the treatment is working, and look for any side effects. These visits will involve physical examinations, blood tests, and scans to monitor your cancer. The study will continue for as long as the treatment is helping you and you are tolerating it well. Even if your cancer starts to grow while on standard treatment, you might have the option to switch to tepotinib if your doctor thinks it's appropriate. After you stop taking the study drug, there will be follow-up appointments to monitor your health.
Potential risks and benefits
Locations (29)
- Besançon - CHUVerified postcodeBesançon, France· Recruiting
- Bordeaux - Institut BergonieVerified postcodeBordeaux, France· Recruiting
- Brest - CHUVerified postcodeBrest, France· Recruiting
- Caen - CRLCCVerified postcodeCaen, France· Recruiting
- Centre Hospitalier Intercommunal de CréteilVerified postcodeCréteil, France· Recruiting
- Dijon - Centre Georges-François LeclercVerified postcodeDijon, France· Recruiting
- Grenoble - CHUVerified postcodeGrenoble, France· Recruiting
- CHD VendéeVerified postcodeLa Roche-sur-Yon, France· Recruiting
- Le Mans - CHGVerified postcodeLe Mans, France· Recruiting
- CHRU de LilleVerified postcodeLille, France· Recruiting
- Centre Léon BérardVerified postcodeLyon, France· Recruiting
- Institut Paoli CalmetteVerified postcodeMarseille, France· Recruiting
Common questions
What is a 'MET Exon 14 mutation'?
It's a specific change in the genes of your lung cancer cells that can make the cancer grow. Some newer drugs are designed to target this change.
What is tepotinib?
Tepotinib is a new treatment designed to specifically block the effects of the MET Exon 14 mutation, aiming to stop the cancer from growing.
Why is this study important if tepotinib is already approved in some places?
This study aims to directly compare tepotinib with standard treatments to provide strong evidence. This comparison is needed to make the drug more widely available and covered by health systems in certain regions, like France.
What kind of side effects can I expect from tepotinib?
Common side effects include swelling (fluid retention), and sometimes changes in liver/kidney tests, nausea, or diarrhoea. Most are mild to moderate and can be managed effectively.
What if my cancer gets worse on the standard treatment arm?
If your cancer starts to grow while you're receiving standard treatment in the study, you may have the option to switch to tepotinib, if your medical team believes it's the right choice for you.
How to find out more
Contact IFCT
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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