A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
This research is investigating a new medication called neladalkib (NVL-655) for people with advanced cancers that have a particular genetic change known as ALK rearrangement. These include certain types of advanced non-small cell lung cancer (NSCLC) and other solid tumours. The study has two main parts: Phase 1 focuses on finding a safe and effective dose of neladalkib. Phase 2 then checks how well the drug works to shrink tumours. There's also a small sub-study to understand how neladalkib interacts with other common medicines. The aim is to find better treatment options for these specific cancers.
At a glance
What is this study about?
This clinical trial is about a new drug called neladalkib (also known as NVL-655). It's being tested for people who have advanced cancer, specifically those whose cancer cells have a particular genetic fault called an ALK rearrangement. This fault acts like a switch, making the cancer grow. Some types of non-small cell lung cancer (NSCLC) and other solid tumours can have this ALK change.
The study has two main stages. In Phase 1, the researchers are carefully giving different doses of neladalkib to a small group of patients. Their main goal is to check how safe the drug is and to work out the best dose to use in future studies. In Phase 2, they will use this best dose in a larger group of patients to see how well it works at shrinking tumours. They will also look at how long the drug's effects last and how it impacts patients' lives.
There's also a smaller part of the study that looks at how neladalkib interacts with other common medicines like midazolam, repaglinide, and itraconazole. This is important to understand if neladalkib can be safely taken alongside other medications you might need. The overall goal of this research is to discover if neladalkib could become a new and effective treatment option for specific cancers with the ALK genetic change.
Key takeaways
- This study is testing a new drug for advanced cancers with an ALK genetic change.
- It's primarily for certain non-small cell lung cancers and other solid tumours.
- The study aims to check the drug's safety and how well it shrinks tumours.
- There are different groups depending on your previous cancer treatments.
- You will be closely monitored by doctors and nurses throughout the study.
- You can stop participating at any time if you change your mind.
Who may be eligible?
To join this study, generally, you need to be at least 18 years old, though some parts of the study for other solid tumours might include patients aged 12 and above who weigh over 40kg. You must have a diagnosis of advanced cancer (either locally advanced or that has spread) where your cancer cells show a specific genetic change called an ALK rearrangement or activating ALK mutation. For the lung cancer groups, you will need to have previously received certain other ALK-targeting drugs, depending on the specific group. Some of the study groups are for people who haven't tried ALK-targeting drugs yet, while others are for those who have tried one or more previous treatments.
There are also reasons why you might not be able to join. For example, if your cancer has other known genetic changes besides ALK that are driving its growth, you likely wouldn't be eligible. If you have an allergy to any part of the neladalkib drug, or if you've had major surgery recently (within 4 weeks), you can't take part. You also shouldn't be receiving other cancer treatments or participating in another drug study at the same time. The study needs to make sure your body organs like your liver, kidneys, and bone marrow are working well.
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 or older (or 12+ if you have certain solid tumours and weigh over 40kg)?
- Has your cancer been identified as having an ALK rearrangement or activating ALK mutation?
- Do you have locally advanced or metastatic cancer?
- Are your body organs, like your liver and kidneys, working soundly?
- Are you currently not receiving any other cancer treatment or participating in another drug study?
- Have you not had a major surgery in the last 4 weeks?
What does participation involve?
If you join this study, you will be given the study drug, neladalkib (NVL-655). The study has two main parts: Phase 1 is about finding the right dose and assessing safety, while Phase 2 looks at how well the drug works. You will have regular visits to the clinic for check-ups, blood tests, and scans (like CT or MRI) to see how your cancer is responding to the treatment. These visits help the doctors monitor your health and any side effects you might experience. There's also a special sub-study where some patients will take other common medicines like midazolam, repaglinide, or itraconazole alongside neladalkib, so researchers can understand how these drugs interact. The total length of your participation will depend on how you respond to the treatment and the stage of the study you are in, but it will involve ongoing assessments and follow-up.
Potential risks and benefits
Locations (74)
- University of California Irvine Medical CenterVerified postcodeOrange, United States· Recruiting
- University of California, Davis Comprehensive Cancer CenterVerified postcodeSacramento, United States· Recruiting
- Stanford Cancer InstituteVerified postcodeStanford, United States· Recruiting
- University of Colorado Cancer CenterVerified postcodeAurora, United States· Recruiting
- Georgetown University Medical CenterVerified postcodeWashington D.C., United States· Recruiting
- University of Miami; Sylvester Cancer CenterVerified postcodeMiami, United States· Recruiting
- Winship Cancer Institute, Emory UniversityVerified postcodeAtlanta, United States· Recruiting
- University of Chicago Medical CenterVerified postcodeChicago, United States· Recruiting
- John Hopkins UniversityVerified postcodeBaltimore, United States· Recruiting
- Massachusetts General HospitalVerified postcodeBoston, United States· Recruiting
- Dana Farber Cancer InstituteVerified postcodeBoston, United States· Recruiting
- Henry Ford Cancer InstituteVerified postcodeDetroit, United States· Recruiting
Common questions
What does 'ALK rearrangement' mean?
It's a specific genetic change in some cancer cells that acts like a switch, causing the cancer to grow. This study is for people whose cancer has this particular fault.
Is this drug approved for use yet?
No, this is a clinical trial, meaning neladalkib is currently an experimental drug and is not yet approved for general use. Researchers are studying its safety and effectiveness.
What is the difference between locally advanced and metastatic cancer?
Locally advanced means the cancer has grown into nearby tissues but hasn't spread to distant parts of the body. Metastatic means the cancer has spread from where it started to other parts of the body.
Will I know if the drug is working?
Yes, you will have regular scans and tests to monitor your cancer. The study doctors will discuss your results with you and assess how well the treatment is working.
What if I experience side effects?
The study team will closely monitor you for any side effects experienced. They will provide care and guidance to manage them and ensure your safety throughout the study.
How to find out more
Nuvalent Clinical Trial
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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