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Study Comparing Rilvegostomig with Fluoropyrimidine and Trastuzumab Deruxtecan to Standard Treatment for Patients with HER2-positive Gastric Cancer

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 stomach cancer known as HER2-positive gastric cancer. This cancer can also affect the area where the stomach meets the esophagus, called the gastroesophageal junction. The study aims to compare two different treatment approaches for patients with this type of cancer. One group of patients will receive a combination of medications including rilvegostomig, fluoropyrimidine, and trastuzumab deruxtecan. The other group will receive a standard treatment that includes trastuzumab, chemotherapy, and pembrolizumab.

The purpose of the study is to evaluate how effective the new combination of medications is compared to the standard treatment. The study will involve patients receiving these treatments and being monitored over time to see how their cancer responds. The researchers will look at how long patients live without their cancer getting worse and their overall survival time. The study will also monitor any side effects that patients may experience during the treatment.

Participants in the study will receive their treatments through infusions, which means the medication is given directly into a vein. Some medications, like capecitabine, may be taken orally as a tablet. The study will continue for several years to gather enough information to determine the effectiveness and safety of the treatments. This research is important for finding better ways to treat HER2-positive gastric cancer and improve outcomes for patients with this condition.

The research process

The trial runs in 6 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, you will be randomly assigned to one of two treatment groups. This means you will either receive the new treatment being tested or the standard treatment currently used for your condition.

  2. Step 2

    Treatment group assignment

    If assigned to the new treatment group, you will receive a combination of rilvegostomig, fluoropyrimidine, and trastuzumab deruxtecan. These medications are administered through an intravenous infusion, which means they are given directly into your vein.

    If assigned to the standard treatment group, you will receive trastuzumab, chemotherapy, and pembrolizumab. These medications are also administered through an intravenous infusion.

  3. Step 3

    Medication administration

    The medications will be given at specific intervals as determined by the study protocol. The exact dosage and frequency will be explained to you by the study team.

    You will continue to receive the assigned treatment for the duration specified in the study, unless there are reasons to stop earlier, such as side effects or disease progression.

  4. Step 4

    Regular check-ups

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and imaging tests.

    These check-ups are important to ensure your safety and to gather data on how well the treatment is working.

  5. Step 5

    Reporting side effects

    You will be asked to report any side effects or changes in your health to the study team. This information helps in understanding the safety of the treatment.

    The study team will provide guidance on managing any side effects you may experience.

  6. Step 6

    End of treatment

    At the end of the treatment period, you will have a final set of assessments to evaluate your response to the treatment.

    The study team will discuss the results with you and provide information on any further steps or follow-up care needed.

Who can join the trial?

12 criteria

  • Must have a type of cancer called HER2-positive gastric cancer, which affects the stomach or the area where the stomach meets the esophagus.
  • Must have a PD-L1 combined positive score (CPS) of 1 or higher. This is a measure used to evaluate certain proteins in cancer cells.
  • Must provide a sample of tumor tissue from a recent biopsy for testing.
  • Must have cancer that is unresectable (cannot be removed by surgery) and either locally advanced or has spread to other parts of the body (metastatic).
  • Must not have received prior treatment for this cancer.
  • Must have a performance status of 0 or 1 according to the WHO or Eastern Cooperative Oncology Group. This is a scale that measures how well a person can perform ordinary tasks and carry out daily activities.
  • Must have measurable disease that can be assessed by the study doctor using specific criteria (RECISTv1.1).
  • Must have adequate organ and bone marrow function as determined by tests within 14 days before starting the study.
  • Must have a left ventricular ejection fraction (LVEF) of 55% or higher within 28 days before starting the study. This is a measure of how well the heart is pumping blood.
  • Must have completed any previous treatments with enough time before starting the study.
  • Open to both male and female participants.
  • Participants must be within the specified age range for the study.

Who cannot join the trial?

7 criteria

  • Patients with any other type of cancer that is not HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma cannot participate. HER2-positive means that the cancer cells have more of a protein called HER2, which can promote the growth of cancer cells.
  • Patients who have previously received treatment with the study drugs rilvegostomig, fluoropyrimidine, T-DXd, trastuzumab, chemotherapy, or pembrolizumab are not eligible. These are specific medications used to treat cancer.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study treatment or the safety of the patient cannot join. This means any serious health issues that are not well-managed.
  • Patients who are pregnant or breastfeeding are not allowed to participate. This is to ensure the safety of both the mother and the baby.
  • Patients who are unable to comply with the study procedures or follow-up visits are not eligible. This means if someone cannot attend regular check-ups or follow the study rules, they cannot take part.
  • Patients with known allergies to any of the study drugs or their components cannot participate. An allergy is when your body reacts negatively to a substance.
  • Patients who have participated in another clinical trial within a certain time frame before this study starts are not eligible. This is to avoid any interference from other treatments.
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Investigated drugs

  • Rilvegostomig

    is a medication being studied for its potential to help treat HER2-positive gastric cancer. It is being tested in combination with other treatments to see if it can improve the time patients live without their cancer getting worse and overall survival.

  • Fluoropyrimidine

    is a type of chemotherapy drug that is used to treat various cancers, including gastric cancer. It works by interfering with the cancer cells' ability to grow and divide, which can help slow down or stop the progression of the disease.

  • Trastuzumab Deruxtecan

    , also known as T-DXd, is a targeted therapy used to treat HER2-positive cancers. It combines a drug that targets the HER2 protein on cancer cells with a chemotherapy agent, helping to deliver the treatment directly to the cancer cells and potentially improving its effectiveness.

  • Trastuzumab

    is a medication that targets the HER2 protein, which is found in high amounts on some cancer cells. By attaching to these proteins, trastuzumab can help slow or stop the growth of the cancer cells.

  • Pembrolizumab

    is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. It works by blocking a specific protein that prevents the immune system from attacking the cancer, thereby boosting the body's natural defenses against the disease.

What is already known about the treatment

Rilvegostomig – Rilvegostomig is administered in combination with other medications for the treatment of HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. It is currently being studied in clinical trials to assess its effectiveness in improving survival rates compared to existing treatments. The medication works by targeting specific proteins on cancer cells, helping to slow down or stop their growth. Rilvegostomig is classified as a targeted therapy, which means it specifically attacks cancer cells while minimizing damage to normal cells.

Investigated diseases

HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma – This is a type of cancer that occurs in the stomach or the area where the stomach meets the esophagus, characterized by the overexpression of the HER2 protein. The disease begins in the glandular cells lining the stomach or gastroesophageal junction and can spread to nearby tissues and organs. As it progresses, the cancer may invade deeper layers of the stomach wall and spread to lymph nodes or distant organs. Symptoms can include difficulty swallowing, weight loss, and abdominal pain. The progression of the disease can lead to further complications as it affects more areas of the body. The presence of the HER2 protein can influence the behavior and growth rate of the cancer cells.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512583-57-00Protocol codeD702AC00001Estimated enrolment840 patientsSponsorAstraZeneca AB

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