Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

LENVAGIST - A multicentre, comparative, placebo-controlled, double-blinded, phase II study of the efficacy of lenvatinib in patients with locally advanced or metastatic GIST after failure of imatinib and sunitinib

This research study is called LENVAGIST and it’s looking at a new drug, lenvatinib (also known as LENVIMA), for people who have a type of cancer called GIST (Gastrointestinal Stromal Tumour). This study is for people whose GIST has spread or come back, and who have already tried other treatments like imatinib and sunitinib, but they didn't work well enough. The main goal is to find out if lenvatinib can keep the cancer from growing or spreading for a longer time. Researchers will also look at how long people live, if the tumour shrinks, how the treatment affects their quality of life, and any side effects. Treatment involves taking capsules by mouth.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Leon Berard

Enrolment target

Start

22 Aug 2024

Patients with metastatic GIST

What is this study about?

This study is investigating a new medicine called lenvatinib, also known as LENVIMA. This medicine is given as capsules that you take by mouth. It's being tested for people who have a specific type of cancer called Gastrointestinal Stromal Tumour, or GIST for short. This is not a study for newly diagnosed GIST, but specifically for patients whose GIST has advanced or spread to other parts of the body, and who have already tried other standard treatments like imatinib and sunitinib without enough success. This means those other medicines are no longer working well enough to control the cancer.

The main aim of this study is to see how well lenvatinib can prevent the cancer from growing or spreading further. This is known as 'Progression-Free Survival'. Essentially, the researchers want to know if this new treatment can keep the cancer stable or shrinking for a longer period of time compared to not taking the drug (or taking a 'placebo'). This is important because it could offer a new option for patients whose current treatments are no longer effective.

Beyond stopping cancer growth, the study will also look at several other key things. Researchers will track how long people live overall, whether tumours shrink, and what impact the treatment has on a patient's daily life and general well-being (this is often called 'Quality of Life'). They will also carefully record any side effects to understand how well people can tolerate the new medicine. This detailed information will help doctors understand if lenvatinib is a safe and effective new treatment for people with this type of GIST.

Key takeaways

This study is testing a new drug, lenvatinib, for advanced GIST.
It's for people whose GIST hasn't responded to previous treatments like imatinib and sunitinib.
The main goal is to see if lenvatinib can stop the cancer from growing for longer.
Participants will receive either lenvatinib or a placebo, taken as capsules.
Researchers will also look at overall survival, tumour shrinkage, quality of life, and side effects.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Critically, you must have advanced GIST cancer that has either spread to other parts of your body or has grown locally. You also need to have already received and not responded well to at least two other GIST treatments, specifically imatinib and sunitinib. This means your doctors have determined these previous treatments are no longer effectively controlling your cancer.

There might be other specific health requirements or conditions that could prevent someone from joining, which your doctor will be able to discuss with you in detail. These are in place to ensure the study is safe for participants and that the results are clear.

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 GIST cancer that has spread or grown locally?
Have you already tried imatinib and sunitinib for your GIST, and they are no longer working well enough?
Are you able to take capsules by mouth?
Are you willing to have regular hospital visits, tests, and scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to either receive the new drug, lenvatinib, or a placebo (a dummy capsule that looks like the drug but contains no active medicine). This is done by chance, like flipping a coin, and neither you nor your doctor will know which you are receiving. Both the active drug and the placebo are taken as capsules by mouth.

You would have regular visits to the hospital for check-ups, scans to monitor your cancer, blood tests, and to answer questions about your health and how you are feeling. These visits will help the doctors understand how the treatment is working and if you are experiencing any side effects. You will also fill out questionnaires about your quality of life.

The total duration of your participation in the study would involve taking the medication for as long as it is benefiting you and hasn't caused unacceptable side effects, followed by a period of follow-up after stopping the study medicine to continue monitoring your health.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as access to a new treatment (lenvatinib) that is not yet widely available for your condition, which might slow down your cancer's growth. However, there's no guarantee the treatment will work for everyone, and you might receive a placebo without any active medicine. Like all medicines, lenvatinib may have side effects, which the study team will monitor closely. You will be given full information about known side effects before you decide to join. It's very important to remember that participating is entirely your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is GIST?

GIST stands for Gastrointestinal Stromal Tumour. It's a type of cancer that usually starts in the digestive system, most commonly in the stomach or small intestine.

What is lenvatinib (LENVIMA)?

Lenvatinib is the new medicine being tested in this study. It's given as capsules you take by mouth and aims to help stop cancer growth.

What does 'placebo-controlled' mean?

This means some participants will receive the active drug, while others will receive a 'dummy' capsule (placebo) that looks the same but contains no medicine, to help compare the drug's effects.

What does 'Progression-Free Survival' mean?

This is a key way researchers measure if the treatment is working. It's the length of time that you live with the disease without it getting worse or spreading.

Can I choose which treatment I receive?

No, you will be randomly assigned to either receive lenvatinib or the placebo. This is done to ensure the study results are fair and unbiased.