Study of Trastuzumab Deruxtecan for Patients with HER2-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer After Trastuzumab Treatment

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What is this study about?

This clinical trial is focused on studying a type of cancer known as HER2-positive gastric cancer and gastro-esophageal junction adenocarcinoma. These are cancers that occur in the stomach and the area where the stomach meets the esophagus. The study is investigating the effectiveness of a treatment called trastuzumab deruxtecan, also known by its code name DS-8201a. This treatment is being compared to a combination of two other medications, ramucirumab and paclitaxel. The purpose of the study is to see if trastuzumab deruxtecan can help patients live longer compared to the other treatment option.

Participants in the study will receive their assigned treatment through an infusion, which means the medication is given directly into the bloodstream through a vein. The study will follow participants over a period of time to monitor their health and the effects of the treatment. The main goal is to compare the overall survival of patients receiving trastuzumab deruxtecan with those receiving ramucirumab and paclitaxel. Other aspects being studied include how long patients live without the cancer getting worse, how well the cancer responds to the treatment, and any side effects that may occur.

This study is open-label, meaning both the participants and the researchers know which treatment is being given. It is designed to include patients who have already been treated with a regimen containing trastuzumab and have experienced progression of their cancer. The study aims to provide valuable information on the potential benefits and safety of trastuzumab deruxtecan for patients with HER2-positive gastric cancer and gastro-esophageal junction adenocarcinoma.

1 joining the study

Upon joining the study, the patient will be required to sign and date the informed consent forms. This is necessary before any study-specific procedures can begin.

The patient must provide a tumor sample for tissue screening to confirm HER2 status, which is a requirement for participation.

2 randomization

The patient will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the treatments being tested.

3 treatment administration

The patient will receive treatment through intravenous use. The specific medications used in the study include trastuzumab deruxtecan, ramucirumab, and paclitaxel.

The dosage and frequency of administration will be determined by the study protocol and the patient’s assigned treatment group.

4 monitoring and follow-up

Throughout the study, the patient will have scheduled visits for monitoring. This includes laboratory tests and other procedures to assess the patient’s health and response to the treatment.

The patient must comply with all study restrictions and scheduled visits to ensure accurate data collection and safety monitoring.

5 end of treatment

The study is estimated to end by October 27, 2025. The patient will continue to be monitored for safety and efficacy of the treatment until the study concludes.

After the final dose of the study drug, the patient will have follow-up visits to monitor any long-term effects and overall health.

Who Can Join the Study?

  • Sign and date the necessary consent forms before starting any study-specific procedures.
  • Have a heart function test showing a Left Ventricular Ejection Fraction (LVEF) of 50% or higher within 28 days before joining the study. LVEF is a measure of how well your heart pumps blood.
  • Must have recovered from any previous surgery or radiation treatment.
  • If you can have children, you must agree to use a highly effective form of birth control or avoid intercourse during the study and for a certain period after the last dose of the study drug. Women must use birth control for at least 7 months, and men for at least 4 months after the last dose.
  • Men must not freeze or donate sperm during the study and for at least 4 months after the last dose of the study drug. Consider preserving sperm before joining the study.
  • Women must not donate or retrieve eggs for their own use during the study and for at least 7 months after the last dose of the study drug. Consider preserving eggs before joining the study.
  • Be willing and able to attend scheduled visits, follow the drug administration plan, undergo laboratory tests, and comply with other study procedures and restrictions.
  • Be an adult, according to local regulations, and able to provide informed consent to participate in the study.
  • Have a confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma that has been previously treated and is in a metastatic stage, meaning it has spread to other parts of the body.
  • Have experienced disease progression after first-line therapy with a trastuzumab-containing regimen. Trastuzumab is a medication used to treat certain types of cancer.
  • Be willing and able to provide a tumor sample for testing to confirm HER2 status. HER2 is a protein that can affect the growth of cancer cells.
  • Have a confirmed HER2-positive status, which means the cancer cells have higher levels of the HER2 protein.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening. This is a scale used to assess how a patient’s disease is progressing and how the disease affects their daily living abilities.
  • Have adequate laboratory test results, including blood counts, within 14 days of joining the study.
  • Have an adequate treatment washout period before joining the study, as described in the study protocol. This means allowing enough time after previous treatments before starting the study treatment.

Who Cannot Join the Study?

  • Patients with other types of cancer that have spread to different parts of the body.
  • Patients who have had a different treatment for their cancer within a certain time frame 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 had an allergic reaction to similar medications in the past.
  • Patients with a history of certain lung diseases.
  • Patients with severe liver or kidney problems.
  • Patients who are unable to follow the study procedures or attend study visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Hospital Universitario De Navarra Pamplona Spain
Medisprof S.R.L. Cluj Napoca Romania
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Hopital Saint Antoine Paris France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E. Vila Real Portugal
Seconda Universita Di Napoli Naples Italy
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Tolna Vármegyei Balassa János Kórház Szekszard Hungary
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
CHU Helora La Louviere Belgium
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Cazqgrope Uqfoimneccrwre Snbrzrilz Woluwe-Saint-Lambert Belgium
Chnwbu Lsom Bwwfov Lyon France
Iijhuudk Mblnaganrj Mlvhwquqvr Paris France
Ayvdustiat Pryckqye Hnneulou Dy Mzqwybned Marseille France
Brqpmbmx Uafrqwxpna Hvehuzyp Ckzmas Besançon France
Nyasqyqr Igxrjomy Obxpjbivw Iqu Mrdlt Sxtbxbszofapqzlkdtkllaliypvx Inwexwme Bfhtmady Cracow Poland
Udvwzktyrf Oh Abxryxi Edegem Belgium
Idghmlaj Cnsbke Drjqveevkrkqbwtnp L'hospitalet De Llobregat Spain
Fjpnhxfvk Pcvl Le Ilwbospgqekyi Bsqtxcfqh Dkj Hzzbxgtl Uapdjrpoykeqx Lq Pte Madrid Spain
Ilkfyjzs dz Cohohliupmbl Hxqlmkvzbgt Uqwvhdjnfkmun de Scnzl Eludktx (gnujpwt Saint Priest En Jarez France
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Ckxyhm Ohuwc Lijsjqg Lille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
25.11.2021
France France
Not recruiting
25.11.2021
Germany Germany
Not recruiting
25.11.2021
Hungary Hungary
Not recruiting
25.11.2021
Ireland Ireland
Not recruiting
25.11.2021
Italy Italy
Not recruiting
25.11.2021
Poland Poland
Not recruiting
25.11.2021
Portugal Portugal
Not recruiting
25.11.2021
Romania Romania
Not recruiting
25.11.2021
Spain Spain
Not recruiting
25.11.2021

Trial locations

Trastuzumab Deruxtecan is a medication used in this trial for patients with HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma. It is designed to target and deliver chemotherapy directly to cancer cells that have a specific protein called HER2 on their surface. This helps to kill the cancer cells while minimizing damage to normal cells.

Ramucirumab is another medication used in this trial. It works by blocking a protein that helps cancer cells grow new blood vessels. By preventing the formation of these blood vessels, the medication aims to slow down or stop the growth of the cancer.

Paclitaxel is a chemotherapy drug used in this trial. It works by stopping cancer cells from dividing and growing, which can help to shrink tumors and slow the progression of the disease.

Investigated diseases:

Metastatic Gastric Adenocarcinoma – This is a type of cancer that begins in the stomach and has spread to other parts of the body. It originates from the glandular cells lining the stomach, which produce mucus and other fluids. As the disease progresses, cancer cells can invade nearby tissues and organs, such as the liver, lungs, and lymph nodes. The spread of cancer to distant sites is known as metastasis, which can complicate the condition. Symptoms may include weight loss, stomach pain, nausea, and difficulty swallowing. The progression of the disease can vary, with some individuals experiencing rapid advancement while others may have a slower course.

Trial ID:
2023-507963-20-00
Protocol code:
DS8201-A-U306
NCT ID:
NCT04704934
Trial Phase:
Therapeutic confirmatory (Phase III)

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