RecruitingPHASE3INTERVENTIONAL

A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

This study is for people with advanced stomach or food pipe cancer that has a specific marker known as HER2. It's a 'Phase 3' study, meaning it's in the later stages of testing new treatments. Researchers are comparing three different combinations of medicines. One combination, called Arm A, includes a new medicine called rilvegostomig with other standard treatments. Arm B uses a different standard combination, and Arm C uses a new combination to help scientists understand which parts of the Arm A treatment are most effective. The main goal is to find out if these new combinations are better and safer than existing treatments for this type of cancer.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

840

Start

01 Mar 2025

Estimated completion

09 Dec 2030

HER2-positive Gastric Cancer Gastroesophageal Junction Adenocarcinoma

What is this study about?

This study is a research project looking into better ways to treat a type of cancer that starts in the stomach or where the food pipe joins the stomach (called the gastroesophageal junction, or GEJ). This cancer has a specific feature called 'HER2-positive', which means it has a lot of a certain protein on the cancer cells. This protein can make the cancer grow faster, but it also means some treatments can specifically target it.

The study aims to compare different combinations of medicines. In simple terms, they want to see if adding a new drug called rilvegostomig to existing treatments can work better than what's currently available. They are also carefully looking at safety, as new drug combinations can sometimes have unexpected side effects. This research is important because it could lead to new, more effective ways to help people with this type of advanced cancer.

Because this is a 'Phase 3' study, it means that the treatments being tested have already shown some promise in earlier research. This stage involves many people across the world to get a very clear picture of how well the new treatments work and what their side effects might be, comparing them directly to current standard care. Finding more effective and safer treatments is key to improving outcomes for patients.

Key takeaways

Tests new drug combinations for advanced HER2-positive stomach/food pipe cancer.
Compares a new drug (rilvegostomig) with current standard treatments.
Aims to find more effective and safer treatment options.
Detailed health checks and regular hospital visits are part of participation.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to have stomach or food pipe cancer that has spread or is advanced, and has the 'HER2-positive' marker. Doctors will also check that your cancer has another specific marker called PD-L1. You can't have had previous treatment for this advanced cancer and would need to be well enough to take part, with good general health and acceptable organ function based on medical tests.

There are also reasons why you might not be able to join. For example, if you have certain other serious health conditions like uncontrolled infections or heart problems. You also couldn't have joined if you've had certain other cancers recently, or if you have a known reaction or allergy to any of the drugs being tested in the study. Your medical team will carefully review all your health information to see if this study is suitable for you.

They would also need to get a fresh tissue sample from your cancer to confirm these markers, and there are specific requirements about how well your body is working, such as your heart pumping strength, which will be checked.

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.

Do you have advanced stomach or food pipe cancer?
Has your cancer been identified as 'HER2-positive'?
Have you not had previous treatment for this advanced cancer?
Do you feel generally well and have good organ function?
Are you able to provide a recent tissue sample of your cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive one of three different combinations of medicines. The doctors and nurses caring for you would know which treatment you are getting, but the research team analysing the results wouldn't. This helps ensure fair results. You would have regular visits to the hospital for your treatments, which will be given intravenously (through a drip) or as tablets, and for various health checks and tests. These tests include blood samples, scans, and possibly heart checks, to monitor your health, how well the treatment is working, and to look for any side effects.

Treatment would continue for a certain period, or as long as the treatment is helping you and you are not experiencing severe side effects. After your main treatment period finishes, you will have follow-up appointments to continually monitor your health and the long-term effects of the treatment. The total duration of your involvement could be several months or even longer, depending on how you respond to the treatment and the follow-up schedule.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and potential risks. A potential benefit could be access to new treatments that might work better than current standard options for your cancer. However, it's also possible that the new treatments might not work for you, or they might cause side effects that are worse or different from standard treatments. All the drugs in this study are known to have potential side effects, and the combination of these drugs may lead to new or more intense side effects. Your study team will discuss all known side effects with you in detail. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (289)

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

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Anchorage, United States· Recruiting
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Phoenix, United States· Recruiting
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Duarte, United States· Recruiting
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La Jolla, United States· Recruiting
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Los Alamitos, United States· Not yet recruiting
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Los Angeles, United States· Recruiting
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Santa Monica, United States· Recruiting
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Solvang, United States· Recruiting
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Upland, United States· Recruiting
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Walnut Creek, United States· Recruiting
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Aurora, United States· Recruiting
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Newark, United States· Not yet recruiting

Common questions

What does 'HER2-positive' mean?

It means your cancer cells have a lot of a specific protein called HER2. This can help doctors choose targeted treatments.

What is a 'Phase 3' study?

It's a large study that compares a new treatment to standard care to see if it's better and safer before it can be widely used.

Will I know which treatment I'm getting?

Your doctors and nurses will know which treatment you're receiving in the study.

What are the main goals of this study?

The main goals are to find out if the new drug combinations are more effective and safer for treating HER2-positive stomach or food pipe cancer.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, and it won't impact your regular medical care.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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