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Study on Datopotamab Deruxtecan and Rilvegostomig for Stage I Non-Small Cell Lung Cancer Patients with ctDNA-Positive or High-Risk Features

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 lung cancer known as Stage I adenocarcinoma non-small cell lung cancer (NSCLC). This study is particularly interested in patients who have a positive result for circulating tumor DNA (ctDNA) or have certain high-risk features after their tumor has been completely removed through surgery. The trial will explore the effectiveness and safety of a new treatment option using a combination of two medications: Datopotamab deruxtecan and Rilvegostomig, which is also known by its code name AZD2936. These medications are given as a solution through a vein, a method known as intravenous infusion.

The purpose of the study is to see if the combination of Datopotamab deruxtecan and Rilvegostomig works better than the standard treatments currently available. Participants in the study will be randomly assigned to receive either the new combination treatment, Rilvegostomig alone, or the standard care, which may include medications like Pemetrexed, Vinorelbine, Carboplatin, Cisplatin, Etoposide, Infliximab, or Mycophenolate mofetil. Some participants may receive a placebo. The study will monitor participants over time to assess how well the treatments work and to check for any side effects.

Throughout the study, researchers will collect information on how long participants remain free of cancer, known as disease-free survival, and overall survival, which is the length of time participants live after starting the study. They will also look at how the treatments affect participants' physical function and quality of life. Additionally, the study will measure the levels of the medications in the blood and check for any immune reactions to the treatments. The trial aims to provide valuable insights into improving treatment options for patients with this type of lung cancer.

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, participants will be randomly assigned to one of the treatment groups. This means that the treatment you receive will be determined by chance, similar to flipping a coin.

    The study aims to evaluate the effectiveness and safety of the combination of datopotamab deruxtecan (referred to as Dato-DXd) with rilvegostomig, or rilvegostomig alone, compared to the standard of care treatment.

  2. Step 2

    Treatment administration

    If assigned to the combination treatment group, you will receive Dato-DXd and rilvegostomig through an intravenous infusion. This means the medication will be given directly into your vein.

    The frequency and dosage of the medications will be determined by the study protocol, which will be explained to you by the study team.

  3. Step 3

    Monitoring and assessments

    Throughout the study, regular monitoring will be conducted to assess your health and the effectiveness of the treatment. This will include physical examinations, blood tests, and imaging scans.

    You will be asked to report any side effects or changes in your health to the study team promptly.

  4. Step 4

    Follow-up visits

    Follow-up visits will be scheduled at specific intervals to monitor your progress. These visits are crucial for evaluating the long-term effects of the treatment.

    During these visits, additional tests and assessments may be conducted to gather comprehensive data on your health status.

  5. Step 5

    Completion of the study

    Upon completion of the study, a final assessment will be conducted to evaluate the overall outcomes of the treatment.

    The study team will provide you with information on any further steps or recommendations based on the results of the study.

Who can join the trial?

11 criteria

  • Must have a confirmed diagnosis of Stage I adenocarcinoma non-small cell lung cancer (NSCLC). This means the lung cancer is in its early stage and is a specific type called adenocarcinoma.
  • Must not have received any treatment for the cancer before.
  • Must have had a complete surgical removal of the lung cancer, with no remaining cancer cells.
  • Must show no signs of cancer in a scan taken after surgery.
  • Must have a positive ctDNA result before surgery or have at least one high-risk feature such as:
    • Visceral pleural invasion (VPI): Cancer has spread to the outer lining of the lungs.
    • Lymphovascular invasion (LVI): Cancer cells are found in the blood vessels or lymph vessels.
    • High-grade histology: The cancer cells look very different from normal cells and may grow more quickly.
    • Must have an ECOG performance status of 0 or 1, which means the person is fully active or has some symptoms but can carry out light work. Must also have a life expectancy of more than 6 months and be fully recovered from surgery.
    • Must have adequate bone marrow reserve and organ function. This means the body can produce enough blood cells and the organs are working well.
    • Open to both male and female participants.
    • Participants must be within a certain age range.

Who cannot join the trial?

8 criteria

  • Patients with a different type of cancer than Stage I adenocarcinoma non-small cell lung cancer (NSCLC) cannot participate.
  • Patients who do not have a ctDNA-positive result or a high-risk pathological feature are excluded. ctDNA stands for circulating tumor DNA, which is DNA from cancer cells found in the blood.
  • Patients who have not had a complete removal of their tumor through surgery are not eligible.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are unable to follow the study procedures or attend required visits are excluded.
  • Patients with other serious health conditions that could interfere with the study are not eligible.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial are excluded.
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Investigated drugs

  • Datopotamab Deruxtecan (Dato-DXd)

    is a medication being studied for its potential to help treat lung cancer. It is designed to target and deliver a powerful anti-cancer drug directly to cancer cells, which may help to kill the cancer cells while causing less harm to normal cells. In this trial, it is being tested to see if it can help prevent the return of cancer after surgery in patients with a specific type of lung cancer.

  • Rilvegostomig

    is another medication being tested in this study. It is being used either alone or in combination with Datopotamab Deruxtecan. Rilvegostomig is intended to help the immune system recognize and attack cancer cells more effectively. The study aims to find out if using Rilvegostomig can improve the chances of staying cancer-free after surgery for lung cancer patients.

What is already known about the treatment

  • Datopotamab Deruxtecan (Dato-DXd)

    This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating Stage I adenocarcinoma non-small cell lung cancer (NSCLC) with specific genetic markers. It is being evaluated for its potential to improve disease-free survival when used after surgery to remove the tumor. Datopotamab Deruxtecan works by delivering a chemotherapy drug directly to cancer cells, which helps to kill them while minimizing damage to healthy cells. It belongs to a class of drugs known as antibody-drug conjugates, which are designed to target and destroy cancer cells more precisely.

  • Rilvegostomig

    This medication is also administered as an injection and is being tested in combination with Datopotamab Deruxtecan or as a standalone treatment for Stage I adenocarcinoma non-small cell lung cancer (NSCLC) with certain high-risk features. The goal of using Rilvegostomig is to enhance the effectiveness of cancer treatment following surgery. It works by targeting specific proteins on cancer cells, helping the immune system to recognize and attack these cells more effectively. Rilvegostomig is part of a group of drugs known as monoclonal antibodies, which are designed to boost the body's natural defenses against cancer.

Investigated diseases

Stage I Adenocarcinoma Non-Small Cell Lung Cancer (NSCLC) – This is an early stage of a type of lung cancer that begins in the glandular cells of the lung. It is characterized by the presence of cancerous cells in the lung tissue, but the cancer has not spread beyond the lung. In Stage I, the tumor is typically small and confined to the lung, making it potentially more manageable. The progression involves the growth of the tumor within the lung, which may eventually lead to symptoms such as coughing or shortness of breath. The presence of circulating tumor DNA (ctDNA) or high-risk pathological features can indicate a more aggressive form of the disease. As the disease progresses, it may advance to further stages if not managed, potentially spreading to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512195-35-00Protocol codeD926TC00001Estimated enrolment660 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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