Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
This is an 'Expanded Access Program' for a new treatment called neladalkib (NVL-655). It's designed for people with advanced non-small cell lung cancer that is ALK-positive, or other types of ALK-positive cancers. The program provides a way to access neladalkib when standard treatments are no longer working well, and you don't have other suitable options. It's also specifically for those who can't take part in the main neladalkib clinical trials. The aim is to give patients early access to this medicine, which is still being studied, when there are no other satisfactory treatments available.
At a glance
What is this study about?
This program is called an "Expanded Access Program." It's set up to provide a new, investigational medicine called neladalkib (NVL-655) to certain patients. This medicine is still being studied, so it's not yet approved for general use. The program is specifically for people who are living with advanced non-small cell lung cancer that has a specific genetic change called ALK-positive, or people with other types of cancer that are also ALK-positive. These are cancers where the ALK gene is altered, which can drive the cancer's growth.
The main idea behind this program is to help patients who have already tried other treatments for their ALK-positive cancer, but these treatments are no longer working well or they've run out of suitable options. It's also for those who, for various reasons, cannot join one of the main clinical trials where neladalkib is being tested. This means it offers an alternative pathway to access a potential new treatment when other options are limited. The drug is considered 'investigational' because its full benefits and risks are still being understood through clinical trials.
Participation in this program is a way to potentially access neladalkib earlier than if you wait for it to complete all its studies and become widely available. It's important to remember that because it's still investigational, its effects can vary, and it might not work for everyone. Your doctor will carefully consider if this program is right for your specific situation.
Key takeaways
- This program provides access to a new, investigational medicine (neladalkib) for ALK-positive cancers.
- It's for patients with advanced disease who have limited treatment options and cannot join a regular trial.
- Neladalkib specifically targets the ALK gene change found in your cancer.
- Potential benefits include accessing a new treatment; potential risks include unknown side effects.
- Your doctor will decide if this program is suitable for your individual situation.
Who may be eligible?
To be considered for this program, you must be at least 18 years old. Your doctor will need to confirm that you have lung cancer (non-small cell type) or another solid tumour, and that your cancer has a specific change in the ALK gene. This ALK change is important because neladalkib is designed to target it.
Also, your doctor must believe that you have no other satisfactory treatment choices left. For people with lung cancer, this usually means you've already tried at least one other ALK-targeting medicine. If you have another type of ALK-positive cancer, you should have tried some other therapy. Crucially, you must also not be able to join an active neladalkib clinical trial, and your body's important organs, like your liver, kidneys, and bone marrow, need to be working well.
However, you won't be able to join if you've already received neladalkib in the past. You also can't be currently receiving other anti-cancer treatments or have had recent surgery, chemotherapy, or radiotherapy within a timeframe specified by the program rules. Your doctor will go through all these details with you to see if you meet the criteria.
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 at least 18 years old?
- Has your doctor confirmed your cancer is ALK-positive?
- Have you explored other treatment options, and your doctor thinks there are no satisfactory alternatives?
- Are you unable to join another clinical trial for neladalkib?
- Are your important organs (like liver, kidneys) working well?
- Have you NOT previously received neladalkib?
What does participation involve?
If you are eligible and choose to take part in this program, it means you will receive the investigational medicine, neladalkib (NVL-655). The specific details about how you take the medicine (e.g., orally, how often) and what appointments you'll need will be explained by your doctor and the study team, as these can vary. You will likely have regular visits to your clinic for medical checks, blood tests, and scans to monitor your health and how you are responding to the treatment. These visits help your medical team keep a close eye on any effects of the medicine.
The total duration of your participation in the program will depend on how you respond to the treatment and your health. This is not a typical clinical trial with a fixed end date, but rather a way to continue receiving the medicine as long as it's helping and safe for you. Your local doctor, who will oversee your care, will guide you through all aspects of taking the medicine and the follow-up appointments.
Potential risks and benefits
Locations (45)
- University Of California Irvine Medical CenterVerified postcodeOrange, United States· Available
- 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
- Henry Ford Cancer InstituteVerified postcodeDetroit, United States· Available
- Washington University in St. LouisVerified postcodeSt Louis, United States· Available
- NYU Langone HealthVerified postcodeNew York, United States· Available
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States· Available
- Duke UniversityVerified postcodeDurham, United States· Available
- The Ohio State UniversityVerified postcodeColumbus, United States· Available
- The University of Texas MD Anderson Cancer CenterVerified postcodeHouston, United States· Available
Common questions
What is 'ALK-positive' cancer?
ALK-positive means your cancer has a specific genetic change in the ALK gene. This change can make the cancer grow, and neladalkib is designed to target it.
Is neladalkib a new, approved treatment?
No, neladalkib is an 'investigational' medicine, meaning it's still being studied in clinical trials and is not yet approved for general use. This program allows early access.
Why can't I join a regular clinical trial for neladalkib?
There are many reasons someone might not qualify for a regular clinical trial. This program is specifically for those who can't participate in a trial but still need access to this medicine.
What if neladalkib doesn't work for me?
Like all treatments, neladalkib may not work for everyone. Your doctor will monitor your response closely, and if it's not helping or causing too many side effects, other options will be discussed.
Will I have to pay for this new medicine?
Expanded Access Programs typically cover the cost of the investigational drug. Your doctor or the program coordinator can confirm any potential costs associated with your care.
How to find out more
Contact for Program Information
Always speak to your GP or specialist before deciding to take part in a study.
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