RecruitingPHASE3INTERVENTIONAL

A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)

This research study is looking at a type of cancer called Gastrointestinal Stromal Tumour (GIST), which grows in the digestive system, usually the stomach or small intestine. This cancer happens when certain cells grow too much. While current treatments help, sometimes the cancer stops responding, so we need new options. This study is for adults whose GIST has recently been diagnosed and has either spread to other parts of the body or cannot be removed by surgery. We are comparing a new medicine, velzatinib, with imatinib, which is the standard treatment. The main goal is to find out if velzatinib can stop the cancer from getting worse for longer, and if it's safe and well-tolerated.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

GlaxoSmithKline

Enrolment target

800

Start

27 Jul 2026

Estimated completion

28 Sep 2032

Gastrointestinal Stromal Neoplasms

What is this study about?

Gastrointestinal Stromal Tumour (GIST) is a type of cancer that starts in the digestive system, most often in the stomach or small intestine. It happens when cells in these areas grow out of control, forming a tumour. Even though we have treatments for GIST, sometimes they stop working over time, so doctors are always looking for new and better ways to help people.

This study is called 'StrateGIST Frontline' and it's for adults who have just been diagnosed with GIST that has either spread to other parts of the body (called 'metastatic') or cannot be completely removed with an operation. The study aims to test a new medicine called velzatinib. It will be compared against imatinib, which is the usual first-choice treatment for GIST.

The main reasons for doing this study are to see if velzatinib can keep the cancer from getting worse for a longer time compared to imatinib, and to check if it's safe and doesn't cause too many side effects. This research could help us find a new treatment option for people with GIST.

Key takeaways

This study tests a new GIST medicine, velzatinib, against the usual treatment, imatinib.
It's for adults newly diagnosed with GIST that has spread or can't be surgically removed.
The main goals are to see if velzatinib delays cancer worsening and is safe.
Participants will be randomly assigned to one of the two medicines.
Regular hospital visits and tests will be needed to monitor health and treatment response.

Who may be eligible?

To join this study, you need to be at least 18 years old and have GIST that has been confirmed by a doctor. Your GIST must have spread or not be removable by surgery, and you shouldn't have had any other treatment for this type of GIST before.

Doctors will also need to get a sample of your tumour tissue, either an old one from when you were first diagnosed or a new one. You must be well enough for a clinical trial, and your body's organs (like your liver and kidneys) need to be working properly. If you are able to have children, you and your partner will need to use reliable contraception throughout the study and for a period afterwards.

You cannot join if you have another type of cancer that has recently been active or needed treatment, or if you are pregnant or breastfeeding. The medical team will check all these points carefully to make sure the study is right and safe 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 at least 18 years old?
Do you have GIST that has spread or cannot be removed by surgery?
Have you not had any prior treatment for this spread GIST?
Are you well enough for a clinical trial, and are your organs working properly?
If you can have children, are you willing to use reliable contraception?
Are you able to provide a tumour tissue sample?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to receive either the new medicine, velzatinib, or the standard medicine, imatinib. This means you won't get to choose which one you receive, similar to flipping a coin.

Your participation will involve regular visits to the clinic for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor your health. You will also have to take the study medicine as prescribed. The medical team will explain the full schedule of visits and tests during the study.

We don't have information on the total duration of the study or the exact number of visits from the brief details provided, but these will be clearly explained by the study team. You will be closely monitored by doctors and nurses throughout the study.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a new investigational treatment that could be more effective than current options, or receiving the established standard treatment with close medical monitoring. However, there are also potential risks involved, as all medicines can have side effects. Velzatinib is an investigational drug, meaning its full range of side effects is still being understood. Imatinib, while standard, also has known side effects. The study team will explain all known and possible risks in detail before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (72)

GSK Investigational Site
Verified postcode
Scottsdale, United States· Recruiting
GSK Investigational Site
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San Francisco, United States· Recruiting
GSK Investigational Site
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New Haven, United States· Recruiting
GSK Investigational Site
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Bethesda, United States· Recruiting
GSK Investigational Site
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Omaha, United States· Recruiting
GSK Investigational Site
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New York, United States· Recruiting
GSK Investigational Site
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Canton, United States· Recruiting
GSK Investigational Site
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Knoxville, United States· Recruiting
GSK Investigational Site
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Seattle, United States· Recruiting
GSK Investigational Site
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Buenos Aires, Argentina· Recruiting
GSK Investigational Site
Unverified
Capital Federal, Argentina· Recruiting
GSK Investigational Site
Unverified
Ciudad Autonoma de Buenos Aire, Argentina· Recruiting

Common questions

What is GIST?

GIST is a type of cancer that grows in your digestive system, most commonly in the stomach or small intestine.

Why is this study important?

Current treatments for GIST can stop working over time, so this study aims to find a new, potentially better medicine (velzatinib) to help people whose cancer has spread or can't be removed by surgery.

What does 'Phase 3' mean for a clinical trial?

Phase 3 means this medicine has already been tested in smaller groups and is now being compared to the standard treatment in a larger group of patients to confirm its effectiveness and safety.

Will I know which medicine I'm getting?

No, you will be randomly assigned to receive either velzatinib or imatinib, like drawing lots. Neither you nor the doctors will know which one you are taking until after the study is complete, unless there's a medical need to find out.

What if I want to stop participating?

You are free to leave the study at any time, for any reason. Your decision will not affect your ongoing medical care.

How to find out more

US GSK Clinical Trials Call Center

gskclinicalsupporthd@gsk.com 877-379-3718 Official trial record

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