Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors
This special program is offering a new medicine called zidesamtinib (also known as NVL-520) to adults in the UK. It's for patients who have advanced non-small cell lung cancer that is 'ROS1-positive', meaning it has a specific change in its genes. It also includes patients with other ROS1-positive cancers. This program is designed for people who have already tried other treatments, don't have many other good options left, and can't take part in a standard clinical trial for zidesamtinib. The aim is to give these patients a chance to access this investigational medicine, which is still being studied, when other treatments haven't worked or aren't suitable.
At a glance
What is this study about?
This programme, called an 'Expanded Access Program', is offering a new medicine called zidesamtinib. This medicine is still being studied, which means it hasn't been fully approved for general use yet. It's specifically for adult patients in the UK who have advanced forms of cancer where a gene called ROS1 has changed (doctors call this 'ROS1-positive'). This includes a certain type of lung cancer called non-small cell lung cancer, and other advanced ROS1-positive cancers.
The main idea behind this programme is to help patients who have very limited treatment choices left. Perhaps they've already tried other medicines for their ROS1-positive cancer, or they don't have good alternative treatments available. Importantly, this programme is for those who cannot join a regular clinical trial looking into zidesamtinib, possibly due to certain health requirements or other reasons.
By offering zidesamtinib through this program, patients who desperately need new options might get a chance to try this medicine. It's important to remember that because zidesamtinib is still being tested, we are still learning about how well it works and its potential side effects.
Key takeaways
- Targets advanced ROS1-positive cancers (lung cancer or other solid tumors).
- For adults who have tried other treatments and have limited options.
- Provides access to an investigational medicine called zidesamtinib.
- Your doctor must confirm you can't join a regular zidesamtinib trial.
- Regular health checks and monitoring are part of the program.
Who may be eligible?
This program is for adults aged 18 or older. You would need to have an advanced cancer (either lung cancer or another solid tumour) where tests have shown a specific change in the ROS1 gene. For lung cancer, you would usually need to have already tried at least one other ROS1 'TKI' medicine. For other ROS1-positive cancers, you would have already tried any other approved or experimental treatment.
Your doctor would need to agree that there are no other good treatment options for you. It's also important that you are not able to join one of the standard clinical trials for zidesamtinib. You must also be generally well enough, with your body organs (like your liver and kidneys) working properly and healthy blood counts.
You would not be able to join if you have already had zidesamtinib before. Also, if you have recently had other cancer treatments like surgery, chemotherapy, or radiotherapy, or are currently having them, you might not be eligible. If you could join an ongoing clinical trial for zidesamtinib, this program would not be suitable for you.
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 advanced ROS1-positive lung cancer or another ROS1-positive solid tumour?
- Have you already received other treatments for your cancer, and does your doctor feel you have limited other options?
- Are you unable to join one of the standard research studies for zidesamtinib?
- Are your body's organs (like liver, kidneys) and blood counts generally healthy?
What does participation involve?
If you are eligible for this programme, you would receive the investigational medicine, zidesamtinib. Visits to the clinic would be scheduled to monitor your health, check for any side effects, and see how the treatment is working. You would likely have regular blood tests, scans, and other assessments.
Specific details about the number of visits, their frequency, and the types of tests would be discussed with you by your doctor. The overall duration of your participation would depend on how your body responds to the treatment and your doctor's assessment.
Potential risks and benefits
Locations (36)
- University of Colorado Anschutz School of MedicineVerified postcodeAurora, United States· Available
- University of Chicago Medical CenterVerified postcodeChicago, United States· Available
- Massachusetts General HospitalVerified postcodeBoston, United States· Available
- Dana-Farber Cancer InstituteVerified postcodeBoston, United States· Available
- Memorial Sloan Kettering Cancer CenterVerified postcodeManhattan, United States· Available
- Fox Chase Cancer CenterVerified postcodePhiladelphia, United States· Available
- University of Washington / Fred Hutchinson Cancer CenterVerified postcodeSeattle, United States· Available
- Chris O'Brien LifehouseVerified postcodeCamperdown, Australia· Available
- Peter MacCallum Cancer CentreVerified postcodeMelbourne, Australia· Available
- UZLeuvenVerified postcodeLeuven, Belgium· Available
- Cross Cancer InstituteVerified postcodeEdmonton, Canada· Available
- Princess Margaret HospitalVerified postcodeToronto, Canada· Available
Common questions
What does 'ROS1-positive' mean?
It means your cancer cells have a specific change in their genes called ROS1, which can sometimes be targeted by certain medicines.
Is zidesamtinib a cure for cancer?
Zidesamtinib is an investigational medicine, meaning it's still being studied. It aims to treat the cancer, but it's not known to be a cure.
What if I'm already in another trial?
If you are currently receiving other anti-cancer therapy or are eligible for an ongoing zidesamtinib clinical trial, you would generally not be able to join this program.
Will I have to pay for the medicine?
Typically, in expanded access programs like this, the investigational medicine is provided free of charge, but this should be confirmed with your doctor.
Can I stop treatment if I want to?
Yes, you have the right to stop taking the medicine and leave the program at any time.
How to find out more
Contact for Program Information
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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