Study of Trastuzumab Deruxtecan and Drug Combination for Patients with Advanced or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer

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What is this study about?

This clinical trial is focused on studying treatments for HER2-positive gastric or gastroesophageal junction cancer, which is a type of cancer that affects the stomach and the area where the stomach meets the esophagus. The study will explore the effectiveness of a new treatment combination involving Trastuzumab Deruxtecan (also known as Enhertu®) along with chemotherapy, with or without the addition of Pembrolizumab. The trial will compare this new combination to the current standard treatment, which includes chemotherapy and Trastuzumab, with or without Pembrolizumab.

The purpose of the study is to determine how well these treatments work in patients who have not received prior treatment for their advanced cancer. Participants will receive their treatment through an intravenous injection, which means the medication is given directly into a vein. The study will last for a period of up to 60 weeks, during which participants will be monitored regularly to assess the progress of their cancer and any side effects they may experience.

Throughout the study, participants will undergo various assessments, including imaging tests like MRI or CT scans, to evaluate the size and spread of the cancer. The trial aims to provide valuable information on the potential benefits of the new treatment combination, which could lead to improved outcomes for patients with this type of cancer. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

1 joining the trial

Upon joining the trial, you will be randomly assigned to one of the treatment groups. This means you will receive a specific combination of medications as part of the study.

2 treatment administration

You will receive medications through different methods. Some medications will be given as an intravenous injection, which means they will be administered directly into your vein. These include cisplatin, oxaliplatin, trastuzumab deruxtecan, trastuzumab, pembrolizumab, and fluorouracil.

Other medications, such as capecitabine, will be taken orally, meaning you will swallow them as pills.

3 medication schedule

The medications will be given in cycles. Each cycle lasts for a specific period, and you will receive the medications at set times during each cycle. The exact schedule, including dosage and frequency, will be explained to you by the medical team.

4 monitoring and assessments

Throughout the trial, your health will be closely monitored. This includes regular visits to the clinic for check-ups, blood tests, and imaging tests like CT or MRI scans to assess how the treatment is working.

You will also be asked to complete questionnaires about your well-being and any side effects you may experience.

5 end of treatment

The treatment will continue until the end of the trial period or until it is determined that the treatment is no longer beneficial for you. The medical team will discuss the next steps with you at that time.

Who Can Join the Study?

Sign and date the necessary consent forms before any trial-specific procedures begin.
Have adequate organ and bone marrow function within 14 days before starting the trial. This means your organs and bone marrow are working well enough to participate.
Have a sufficient break from previous treatments before starting the trial.
If you can have children, agree to use a highly effective form of birth control or avoid intercourse during the trial and for a specified time after the last dose of the trial medication.
Men must not freeze or donate sperm during the trial and for at least 4 months after the last dose of the trial medication.
Women must not donate or retrieve eggs during the trial and for at least 7 months after the last dose of the trial medication. They should also not breastfeed during this time.
Be willing and able to attend scheduled visits, follow the trial plan, and complete required tests and procedures.
Be willing and able to participate in the collection of Patient-Reported Outcomes (PRO) data, which involves answering questions about your health and well-being.
Be at least 18 years old on the day of signing the consent form.
Have a type of stomach or gastroesophageal cancer that has not been treated before and cannot be removed by surgery.
Have cancer that is HER2-positive, which means the cancer cells have more HER2 protein than normal, as confirmed by a specific test.
Have a tumor sample tested for PD-L1 expression, which is a protein that can affect the immune system’s response to cancer.
Provide a tumor sample for testing to determine HER2 and PD-L1 status.
Have at least one measurable tumor that can be seen on a CT or MRI scan.
Have a Left Ventricular Ejection Fraction (LVEF) of at least 50% within 28 days before starting the trial. LVEF is a measure of how well your heart pumps blood.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.

Who Cannot Join the Study?

Patients with other types of cancer that are not related to the study.
Patients who have had another cancer treatment within a certain period before the study.
Patients with serious heart problems.
Patients with uncontrolled high blood pressure.
Patients with active infections that need treatment.
Patients who are pregnant or breastfeeding.
Patients who have allergies to the study medication.
Patients with a history of severe allergic reactions.
Patients with a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Cliniques Universitaires Saint-Luc	Woluwe-Saint-Lambert	Belgium
Institut Jules Bordet	Anderlecht	Belgium
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Vall d’Hebron	Barcelona	Spain
Institutul Regional De Oncologie Iasi	Iasi	Romania
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
Virgen del Rocío University Hospital	Sevilla	Spain
Fakultni nemocnice Motol a Homolka	Prague	Czechia
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Medical University Of Vienna	Vienna	Austria
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Akershus University Hospital	Lorenskog	Norway
Hospital Clinic De Barcelona	Barcelona	Spain
Helse Bergen HF	Bergen	Norway
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)	Rotterdam	The Netherlands
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Azienda Ospedaliera Universitaria Citta’ Della Salute E Della Scienza Di Torino	Turin	Italy
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Universitaet Leipzig	Leipzig	Germany
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Centr Georges Francois Leclerc	Dijon	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Technische Universitaet Dresden	Dresden	Germany
Centre hospitalier universitaire de Liege	Liege	Belgium
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Oslo Universitetssykehus HF	Oslo	Norway
Deutsches Herzzentrum Berlin	Berlin	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Institut Catala D’oncologia	L'hospitalet De Llobregat	Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz	Madrid	Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Hospital Universitario De Navarra	Pamplona	Spain
CHU Grenoble Alpes	La Tronche	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Istituto Oncologico Veneto	Padua	Italy
Hopital Saint Antoine	Paris	France
Hopital Prive Jean Mermoz	Lyon	France
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Pia Fondazione Di Culto E Religione Card G Panico	Tricase	Italy
Centre Oscar Lambret	Lille	France
Haematologisch Onkologische Praxis Eppendorf	Hamburg	Germany
Champalimaud Clinical Centre	Lisbon	Portugal
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Goethe University Frankfurt	Frankfurt	Germany
University Hospital Olomouc	Olomouc	Czechia
Netherlands Cancer Institute	Amsterdam	The Netherlands
Hospital Foch	Suresnes	France
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital General Universitario Morales Meseguer	Murcia	Spain
St. Olavs Hospital HF	Trondheim	Norway
ARNAS Garibaldi Di Catania	Catania	Italy
Institut Mutualiste Montsouris	Paris	France
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Frisius	Heerenveen	The Netherlands
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Cracow	Poland
Medical University Of Graz	Graz	Austria
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Oncopole Claudius Regaud	Toulouse	France
Hopital Beaujon	Clichy	France

Other Sites

Site Name	City	Country
Hospital Da Luz S.A.	Lisbon	Portugal
Fundeni Clinical Institute	Bucharest	Romania
Centre Regional Lutte Contre Le Cancer	STRASBOURG, Alsace	France
Sint-Lucas General Hospital	Brugge	Belgium
Medisprof S.R.L.	Cluj Napoca	Romania
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland
Institut Sainte Catherine	Avignon	France
Cqtrsg Hggjbihomss Ujfzazwxdmdvt Diivxc Ggielwl Szoakbpxvleyorqjpvetuhjuig	Namur	Belgium
Svkwxmrezn Sbmibkcg Sezorp	Suceava	Romania
Nhi Ltm Gdqkhxqgil Tsdzczbrldwpv Gyxq	Wiener Neustadt	Austria
Kslbmqvt Cjflhjll gjkkt	Chemnitz	Germany
Soz Jfnoe Kxhrlyhvbqy Gvsd	Vienna	Austria
Vbgrngat Nrbmgdza fozx Gebsplctqj Gmax	Berlin	Germany
Wspndzklvxmbt Cnlcwfv Ogcanrcvi Iwy Mnpiz Sujpwrmcofgexpzkdg	Poznan	Poland
Mk Aisaunvf Cdgrog Cgogly	Madrid	Spain
Oorvqys Celxdxff Hmtvxsxb Susrpv	Ovidiu	Romania
Brdflddifl Cnkrgjy Oadnngsjp Selubdf Mvnhuoj Igg Jglr Pqxkv Ix W Bafzqfwpjbqwxd Srums	Bielsko-Biala	Poland

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	02.06.2025
Belgium	Recruiting	02.06.2025
Czechia	Recruiting	02.06.2025
France	Recruiting	02.06.2025
Germany	Recruiting	02.06.2025
Italy	Recruiting	02.06.2025
Norway	Recruiting	02.06.2025
Poland	Recruiting	02.06.2025
Portugal	Recruiting	02.06.2025
Romania	Recruiting	02.06.2025
Spain	Recruiting	02.06.2025
The Netherlands	Recruiting	02.06.2025

Trial locations

Investigated Drugs:

Trastuzumab Deruxtecan (Enhertu®) is a medication used in this trial to treat certain types of cancer. It is a combination of two parts: one part targets cancer cells that have a protein called HER2, and the other part helps to kill these cancer cells. This medication is being tested to see if it can help people with advanced stomach cancer or cancer at the junction of the stomach and esophagus.

Pembrolizumab is a type of therapy known as immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, it is being used to see if it can improve the treatment of advanced stomach cancer when combined with other medications.

Trastuzumab is another medication used in this trial. It targets the HER2 protein on cancer cells, similar to Trastuzumab Deruxtecan. By attaching to this protein, it can help slow down or stop the growth of cancer cells. This trial is testing its effectiveness in combination with other treatments for advanced stomach cancer.

Unresectable, Locally Advanced or Metastatic HER2 positive Gastric or Gastroesophageal Junction Cancer – This type of cancer occurs in the stomach or the area where the stomach meets the esophagus, known as the gastroesophageal junction. It is characterized by the overexpression of the HER2 protein, which promotes the growth of cancer cells. The disease is considered unresectable when it cannot be removed completely through surgery. As it progresses, the cancer may spread to nearby tissues and organs, becoming locally advanced. In metastatic cases, the cancer cells travel to distant parts of the body, forming new tumors. The progression of this cancer can lead to symptoms such as difficulty swallowing, weight loss, and abdominal pain.

Trial ID:

2024-513122-27-00

Protocol code:

DS8201-724

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Trastuzumab Deruxtecan and Drug Combination for Patients with Advanced or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?