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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

15 criteria

  • 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 trial?

10 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

  • Trastuzumab Deruxtecan

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating HER2-positive metastatic gastric adenocarcinoma. It is an antibody-drug conjugate that targets the HER2 receptor on cancer cells, delivering a cytotoxic agent directly to the tumor, thereby inhibiting cancer cell growth. Trastuzumab Deruxtecan is classified as an antineoplastic agent and is being evaluated for its potential to improve overall survival in patients who have progressed after previous treatments.

  • Ramucirumab

    Administered intravenously, Ramucirumab is being evaluated in clinical trials for its use in treating HER2-positive metastatic gastric adenocarcinoma. It works by blocking the VEGF receptor, which is involved in the formation of new blood vessels that tumors need to grow. This medication is classified as an angiogenesis inhibitor and is being studied for its ability to slow down or stop the progression of cancer in combination with other treatments.

  • Paclitaxel

    This medication is given intravenously and is part of ongoing clinical trials for treating HER2-positive metastatic gastric adenocarcinoma. Paclitaxel works by stabilizing microtubules, preventing cell division, and ultimately leading to cancer cell death. It is classified as a mitotic inhibitor and is being tested in combination with other drugs to assess its effectiveness in improving patient outcomes.

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 detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507963-20-00Protocol codeDS8201-A-U306Estimated enrolment490 patientsSponsorDaiichi Sankyo Inc.

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