Active not recruitingPHASE3INTERVENTIONAL

Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

This UK clinical trial is testing a new medication called trastuzumab deruxtecan for adults with stomach cancer or cancer where the food pipe joins the stomach. This particular cancer is called HER2-positive, meaning it has a specific protein that helps it grow. Patients joining this study will have already been treated with a different trastuzumab-containing drug, but their cancer has either progressed or returned. The study will see how well the new drug works compared to a combination of two established treatments, ramucirumab and paclitaxel, and also check for any side effects. Researchers hope to find a more effective treatment option for these patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Daiichi Sankyo

Enrolment target

490

Start

21 May 2021

Estimated completion

31 Aug 2026

Gastric Cancer, Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

What is this study about?

This study, called DESTINY-Gastric04, is for people in the UK who have a type of cancer affecting their stomach or the area where the food pipe meets the stomach. Specifically, it's for what doctors call 'HER2-positive adenocarcinoma'. HER2-positive means the cancer cells have a lot of a protein called HER2 on their surface, which can help the cancer grow. Knowing if your cancer is HER2-positive helps doctors choose the best treatment.

Patients taking part will have already received a treatment that included a drug called trastuzumab, but sadly, their cancer has either started to grow again or did not respond as well as hoped. This trial wants to see if a newer drug, trastuzumab deruxtecan, can be a better option. It will be compared against a standard treatment combination of ramucirumab and paclitaxel, which are already used for this type of cancer. The main goal is to find out if the new drug helps people live longer.

Beyond living longer, the study will also look at other important things. This includes how long patients live without their cancer growing, how many patients respond to the treatment, how long that response lasts, and how well the treatments are tolerated, meaning what side effects might occur. By carefully comparing these treatments, doctors hope to discover better ways to help people with HER2-positive stomach or food pipe cancer.

Key takeaways

This study is for HER2-positive stomach or food pipe cancer that has progressed after previous trastuzumab treatment.
It compares a new drug (trastuzumab deruxtecan) to a standard combination of treatments.
The main goal is to see if the new drug helps people live longer and is safe.
You would be randomly assigned to one of the two treatment groups.
Regular hospital visits, tests, and monitoring for side effects are part of being in the study.

Who may be eligible?

To be considered for this study, you need to be an adult in the UK with stomach cancer or cancer where the food pipe meets the stomach, and your cancer must be HER2-positive. This means tests on your cancer tissue showed it has a specific protein that the study drug targets. Importantly, your cancer would have already been treated with a trastuzumab-containing drug, but it has started to grow again or did not respond as expected. You must not have had other cancer treatments after your trastuzumab therapy.

There are also some health checks. Your general health and how well you can perform daily activities (measured by something called an 'ECOG score' of 0 or 1) are important. Your blood tests, including those for your bone marrow, kidneys, liver, and blood clotting, need to be within a healthy range. You also can't have certain heart conditions or specific lung issues that need medication.

Some things would mean you can't join. If you've had a heart attack recently or have significant heart failure, or certain irregular heart rhythms, you wouldn't be eligible. Also, having certain lung conditions or other inflammatory disorders could prevent you from participating.

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 an adult with stomach cancer or cancer where your food pipe meets your stomach?
Has your cancer been identified as 'HER2-positive'?
Have you already had treatment for your cancer that included trastuzumab, but it has started to grow again?
Are you generally in good health and able to manage daily activities?
Do you have healthy kidney, liver, and blood test results?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive one of two treatments: either trastuzumab deruxtecan or a combination of ramucirumab and paclitaxel. Receiving treatment means you'll have regular hospital visits for drug infusions and check-ups. These visits will include blood tests, imaging scans (like CT scans) to see how your cancer is responding, and assessments of any side effects you might experience. The exact number of visits and the total duration in the study will vary depending on how you respond to the treatment and how long the treatment works for you. You will also have follow-up appointments after your treatment ends to monitor your health.

Potential risks and benefits

Participating in this trial could offer the benefit of access to a new, potentially more effective treatment for your cancer that isn't yet widely available. The study aims to improve cancer control and potentially extend life compared to current standard treatments. However, like all medications, the study treatments carry risks of side effects, which can range from mild to severe, and may include problems with your heart, lungs, or other organs. You will be monitored closely for these. It's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (156)

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

Instituto Medico Especializado Alexander Fleming
Verified postcode
Colegiales, Argentina
IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo
Unverified
Nueva Cordoba, Argentina
Exelsus
Verified postcode
San Miguel de Tucumán, Argentina
Fundacion Cenit
Verified postcode
Buenos Aires, Argentina
UCL St. Luc
Verified postcode
Brussels, Belgium
Antwerp University Hospital
Verified postcode
Edegem, Belgium
Pôle Hospitalier Jolimont
Verified postcode
Haine-Saint-Paul, Belgium
UZ Leuven
Verified postcode
Leuven, Belgium
PERSONAL - Oncologia de Precisao e Personalizada
Verified postcode
Belo Horizonte, Brazil
Hospital Sirio Libanes
Verified postcode
Brasília, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia LTDA
Verified postcode
Ijuí, Brazil
Hospital Ernesto Dornelles
Verified postcode
Porto Alegre, Brazil

Common questions

What does 'HER2-positive cancer' mean?

It means your cancer cells have a lot of a specific protein called HER2 on their surface, which can make the cancer grow and spread. Doctors test for this to help choose the best treatment.

What is the new drug, trastuzumab deruxtecan?

It's a new type of cancer drug designed to target HER2-positive cancer cells more precisely. It delivers a chemotherapy agent directly to the cancer cells, hopefully causing fewer side effects elsewhere in the body.

Why is my cancer being called 'gastric' or 'gastro-esophageal junction'?

Gastric cancer is stomach cancer. Gastro-esophageal junction cancer is found in the area where your food pipe (oesophagus) connects to your stomach.

Will I definitely get the new drug?

No, you will be randomly assigned to receive either the new drug (trastuzumab deruxtecan) or a combination of two standard drugs (ramucirumab + paclitaxel). It's like flipping a coin, so it's a 50/50 chance.

What are ramucirumab and paclitaxel?

These are established cancer treatments. Ramucirumab works by stopping blood vessel growth to the tumour, and paclitaxel is a type of chemotherapy that kills cancer cells.