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RecruitingPHASE2, PHASE3INTERVENTIONAL

DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage/Young Adult Patients With ROS1 Gene Fusion-Positive Cancers.

This research is looking into a drug called entrectinib for various types of cancer in adults, teenagers, and children. Entrectinib is already used for some lung cancers and other specific tumours. Researchers want to find out if it can help patients whose cancers also have a particular cell change, known as a ROS1 gene fusion, even if it's a different type of cancer. The aim is to see if this drug could become a standard treatment for more people in the future, especially for rare cancers or common cancers with this specific cell change. This is part of a larger programme called DETERMINE, which matches drugs to cancers with particular genetic features.

At a glance

Status
Recruiting
Phase
PHASE2, PHASE3
Sponsor
Cancer Research UK
Enrolment target
30
Start
30 Nov 2025
Estimated completion
01 Oct 2029

What is this study about?

This study is called the DETERMINE trial, and it's focusing on a specific drug known as entrectinib. You might have heard of entrectinib because it's already approved and used in the UK for certain types of adult lung cancer and some other tumours in young people aged 12 and over. These are specific cancers that have a particular genetic change in their cells, which scientists call a ROS1-positive gene fusion.

Researchers now want to explore if entrectinib could also be helpful for people with other types of cancer that have this same ROS1 gene fusion. This could include rare cancers or more common cancers that just happen to have this specific genetic change. If the trial shows positive results, the team hopes to work with the NHS and the Cancer Drugs Fund to make sure these new treatment options could eventually be available to more patients.

This trial is part of a bigger research effort called DETERMINE. The whole programme aims to find new ways to treat cancer by matching specific anti-cancer drugs to rare cancers or cancers with particular genetic changes. Think of it like trying to find the right key (the drug) for a specific lock (the cancer with a certain genetic change).

Key takeaways

  • This study tests if entrectinib can treat cancers with a specific 'ROS1 gene fusion' change.
  • It's for different cancers, including rare ones, in adults, teenagers, and children.
  • Entrectinib is already approved for some lung cancers, but this study explores new uses.
  • Participation involves taking the drug, providing biopsies and blood samples, and follow-up care.
  • The goal is to make successful treatments more widely available through the NHS.
  • You can stop participating at any time if you wish.

Who may be eligible?

To be considered for this study, your cancer must have a specific change in its cells called a ROS1 gene fusion. This must have been found using a special genetic test. Importantly, if you have non-small cell lung cancer, you generally won't be eligible for this particular part of the study, as entrectinib is already approved for that. You'll also need to be able to provide a fresh tissue sample (a biopsy) and blood samples for the research.

Your organs, such as your kidneys and liver, need to be working well enough for you to take part. This will be checked with blood tests. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test and agree to use effective contraception throughout the study. The study is open to both adults and children, as long as they meet the specific health and genetic requirements.

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.

  1. My cancer has a ROS1 gene fusion.
  2. I am able and willing to have a new biopsy and give blood samples.
  3. My organs (like kidneys, liver) are working well enough.
  4. If I am a woman who could get pregnant, I am willing to use effective contraception.
  5. I understand I will need regular check-ups and follow-up.
Answer every question to see your result.

What does participation involve?

If you decide to join this study, the first step is a 'screening' process. Experts will look at your cancer's genetic information to see if it matches the study's requirements. If it does, you'll have a new biopsy (a small tissue sample taken from your cancer) and give blood samples for further research.

Once enrolled, you'll receive the drug entrectinib. You'll keep taking it either until your cancer starts to grow again, if the side effects become too much to handle, or if you decide you no longer want to participate. Throughout this time, you'll provide more blood samples at different times. After you finish taking the drug, doctors will continue to follow up with you every three months for two years to monitor your health.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as gaining early access to a new treatment that might help if other options haven't worked or aren't available. However, there are also potential risks, including side effects from the drug entrectinib, which your doctor will discuss with you. There's no guarantee the treatment will work for you, and sometimes new treatments don't prove to be effective. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (27)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Belfast City Hospital
    Verified postcode
    Belfast, United Kingdom· Recruiting
  • University Hospital Birmingham
    Verified postcode
    Birmingham, United Kingdom· Recruiting
  • Birmingham Children's Hospital
    Verified postcode
    Birmingham, United Kingdom· Not yet recruiting
  • Bristol Royal Hospital for Children
    Verified postcode
    Bristol, United Kingdom· Recruiting
  • Bristol Haematology and Oncology Centre
    Verified postcode
    Bristol, United Kingdom· Recruiting
  • Addenbrooke's Hospital
    Verified postcode
    Cambridge, United Kingdom· Recruiting
  • Velindre Cancer Centre
    Verified postcode
    Cardiff, United Kingdom· Recruiting
  • Cardiff Children's Hospital
    Verified postcode
    Cardiff, United Kingdom· Not yet recruiting
  • Western General Hospital
    Verified postcode
    Edinburgh, United Kingdom· Recruiting
  • The Beatson Hospital
    Verified postcode
    Glasgow, United Kingdom· Recruiting
  • Royal Hospital for Children Glasgow
    Verified postcode
    Glasgow, United Kingdom· Recruiting
  • Leicester Royal Infirmary
    Verified postcode
    Leicester, United Kingdom· Recruiting

Common questions

What is a 'ROS1 gene fusion'?

It's a specific change in the genetic information inside your cancer cells that makes them grow. The study is for cancers with this specific change.

Is entrectinib a new drug?

Entrectinib is already approved for some types of cancer, but this study is testing if it can help other cancers that also have the ROS1 gene fusion.

Will I have to pay for the drug?

No, if you're accepted into the study, the drug and study-related care will be provided as part of the research.

Can children join this study?

Yes, children, teenagers, and adults can all potentially take part, as long as they meet the specific requirements.

What happens if the drug doesn't work for me?

The study team will monitor your progress closely. If the drug isn't helping or if the side effects are too much, you will stop taking it and your doctors will discuss other treatment options with you.

How to find out more

Aida Sarmiento Castro

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paed…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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