Active not recruitingPHASE3INTERVENTIONAL

A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers

This research study is testing a new treatment for people with advanced cancers of the stomach and gullet (oesophagus) that are HER2-positive. This means the cancer cells have a lot of a specific protein called HER2. The study is comparing a new drug called zanidatamab (given with chemotherapy, and sometimes an additional drug called tislelizumab) against the current standard treatment, trastuzumab (also given with chemotherapy). The main goal is to find out if the new treatment is more effective at treating these cancers and if it is safe to use. Patients taking part will have cancers that cannot be removed by surgery or have spread to other parts of the body.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Jazz Pharmaceuticals

Enrolment target

920

Start

02 Dec 2021

Estimated completion

31 Jul 2027

Gastric Neoplasms Gastroesophageal Adenocarcinoma Esophageal Adenocarcinoma

What is this study about?

This study is for people who have advanced cancer of the stomach or gullet (also known as the oesophagus). Advanced cancer means it has either grown locally, has come back, or has spread to other parts of the body. For this study, the cancer must specifically be 'HER2-positive'. This means that the cancer cells produce a lot of a certain protein called HER2, which can make the cancer grow and spread.

The main purpose of this study is to compare a new drug, zanidatamab, with the standard treatment, trastuzumab. Both of these drugs are given alongside chemotherapy. Sometimes, an additional drug called tislelizumab might also be included with zanidatamab. Researchers want to see if this new combination of treatments helps people more effectively than the current standard treatment. They are also looking to understand if the new treatments are safe and what side effects they might cause.

Taking part in a study like this helps doctors learn more about cancer and find better ways to treat it in the future. The treatments involved are investigational, meaning they are still being studied and are not yet approved for general use. The study is in Phase 3, which means it's one of the final steps before a treatment might be considered for wider use.

Key takeaways

This study evaluates a new treatment for advanced HER2-positive stomach and gullet cancers.
It compares a new drug (zanidatamab) with standard treatment (trastuzumab), both combined with chemotherapy.
Sometimes, an additional drug (tislelizumab) might be included with zanidatamab.
The aim is to find out if the new treatment is safer and more effective.
Participation involves regular hospital visits, monitoring, and potentially receiving an experimental treatment.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, your doctor will need to confirm that your stomach or gullet cancer is HER2-positive. Your cancer must also be advanced, meaning it cannot be removed by surgery, has come back, or has spread to other parts of your body. Doctors will check that your general health is good enough for you to take part, including how well your heart and other organs are working.

You would not be able to join if you have previously had certain HER2-targeted treatments (unless it was for breast cancer more than 5 years ago) or treatments that work by boosting your body's immune system. Also, if you have certain other serious medical conditions like untreated brain tumours or active hepatitis, or if you have had other cancers recently, you would likely not be able to participate. The study is open to adults aged 18 and over.

Quick self-check

Do I have advanced HER2-positive stomach or gullet cancer?
Has my cancer spread or is it not treatable by surgery?
Have I had certain HER2-targeted treatments before (excluding some breast cancer treatments over 5 years ago)?
Do I have any other serious health conditions like untreated brain tumours or active hepatitis?
Am I aged 18 or older?
Is my general health good enough for clinical trial participation, as assessed by my doctor?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

The detailed steps of what taking part involves are usually explained thoroughly by the study team. Generally, you would have regular hospital visits for check-ups, blood tests, scans, and to receive your study medication. These visits usually involve getting infusions (medication given through a drip) and taking other medications as prescribed. The frequency of visits might change over time, being more often at the beginning and then less frequent. You would be monitored closely for any side effects. You will also have follow-up appointments even after treatment ends to see how you are doing in the long term. The total duration of your involvement can vary depending on your response to treatment and the study schedule, but can run for several months or even longer.

Potential risks and benefits

Participating in a clinical trial might offer the benefit of receiving a new treatment before it's widely available, which could potentially be more effective for your cancer. However, there's no guarantee the new treatment will work better than standard care, and it might have side effects that are not fully known yet, which could be unpleasant or serious. All medical procedures carry some risks. You will be closely monitored for any side effects or problems, and you can choose to leave the study at any time, for any reason, without affecting your future medical care.

Locations (227)

Hospital de Gastroenterología Dr Bonorino Udaondo
Buenos Aires, Argentina
Instituto de Investigaciones Metabólicas - IDIM
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Fundación Centro de Medicina Nuclear y Molecular ER
Córdoba, Argentina
Centro Médico Privado CEMAIC
Córdoba, Argentina
Centro de Investigación Pergamino S.A.
Pergamino, Argentina
Centro de Investigación Clínica - Clínica Viedma
Viedma, Argentina
Flinders Medical Centre
Bedford Park, Australia
Austin Health
Heidelberg, Australia
Liverpool Hospital
Liverpool, Australia
Fiona Stanley Hospital
Murdoch, Australia
Imelda VZW
Bonheiden, Belgium

+215 more sites — see the official record for the full list.

Common questions

What does 'HER2-positive' mean?

It means your cancer cells have a lot of a specific protein called HER2 on their surface, which can encourage the cancer to grow. Treatments targeting HER2 proteins can be very effective.

What kind of cancer is this study for?

This study is for advanced cancer of the stomach or gullet (oesophagus) that has been identified as HER2-positive, and which cannot be removed by surgery or has spread.

What are the new drugs being tested?

The main new drug is called zanidatamab. It is being tested alongside chemotherapy, and sometimes with another drug called tislelizumab.

Will I definitely get the new treatment?

No, because this is a comparative study, you will be randomly assigned to either receive the new treatment combination or the current standard treatment, which is trastuzumab plus chemotherapy.

What is Phase 3 of a clinical trial?

Phase 3 is usually one of the last steps where a new treatment is compared to existing treatments in a larger group of people. If it shows good results, it may then be considered for wider use.