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Study on Durvalumab and Domvanalimab for Patients with Stage III Unresectable Non-Small Cell Lung Cancer After Chemoradiation Therapy

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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 Non-Small Cell Lung Cancer (NSCLC), specifically in patients with advanced stages of the disease that cannot be surgically removed. The study is investigating the effects of a combination of two medications, Durvalumab and Domvanalimab (also known by the code name AB154), compared to Durvalumab with a placebo. Durvalumab is a medication that helps the immune system fight cancer, and Domvanalimab is a type of antibody that targets specific proteins in the body to help control the cancer. The purpose of the study is to see if the combination of these two medications is more effective than using Durvalumab alone.

Participants in this study are those whose cancer has not worsened after receiving a specific type of treatment called chemoradiation therapy, which combines chemotherapy and radiation. The study will involve regular monitoring of the participants' health and the progression of their cancer over a period of time. The treatment will be administered through an infusion, which means the medication is given directly into the bloodstream through a vein. The study aims to determine if the combination of Durvalumab and Domvanalimab can help improve the time patients live without their cancer getting worse.

Throughout the study, participants will receive either the combination of Durvalumab and Domvanalimab or Durvalumab with a placebo. The study will last for a set period, during which participants will be closely monitored by healthcare professionals. The goal is to gather information on how well the treatment works and its safety. This research could potentially lead to new treatment options for patients with advanced NSCLC, providing hope for better management of this challenging condition.

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, eligibility is confirmed based on specific criteria, including age, medical history, and previous treatments.

    Participants must have a confirmed diagnosis of locally advanced, unresectable non-small cell lung cancer (NSCLC) and have completed concurrent chemoradiation therapy (cCRT) without disease progression.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the combination of durvalumab and domvanalimab or durvalumab and a placebo.

    This process ensures that the study results are unbiased and scientifically valid.

  3. Step 3

    Treatment administration

    The treatment involves the administration of durvalumab and domvanalimab or durvalumab and a placebo through intravenous infusion.

    The specific dosage and frequency of administration are determined by the study protocol and are monitored by healthcare professionals.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular monitoring to assess the progression of the disease and the effectiveness of the treatment.

    Assessments include imaging studies and other tests as specified in the study protocol.

  5. Step 5

    Follow-up

    Participants continue to be monitored for progression-free survival (PFS) and overall survival (OS) as part of the study's primary and secondary endpoints.

    Follow-up assessments are conducted at regular intervals to evaluate the long-term effects of the treatment.

Who can join the trial?

11 criteria

  • Participants must be at least 18 years old at the time of screening.
  • Participants must have a type of lung cancer called NSCLC (non-small cell lung cancer) that has been confirmed through tests.
  • Participants must have been treated with a combination of chemotherapy and radiation for lung cancer that is advanced and cannot be removed by surgery.
  • Participants must provide a sample of their tumor tissue that was taken before they received chemotherapy and radiation.
  • The tumor must show a PD-L1 status of 1% or higher, which is determined by a central laboratory. PD-L1 is a protein that can be found on cancer cells.
  • The tumor must not have certain genetic changes known as EGFR and ALK mutations.
  • Participants must not have experienced worsening of their cancer after receiving a specific type of chemotherapy and radiation.
  • Participants must have received at least two cycles of chemotherapy that includes a drug called platinum, along with radiation therapy.
  • Participants must have received a specific amount of radiation, between 54 and 66 units (called Gy), as part of their treatment.
  • Participants must have a WHO performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • Participants must have organs and bone marrow that are functioning well enough to participate in the study.

Who cannot join the trial?

10 criteria

  • Participants with a different type of cancer than the one being studied.
  • Participants whose cancer has spread to other parts of the body.
  • Participants who have had surgery to remove their lung cancer.
  • Participants whose tumors do not show a certain level of a protein called **PD-L1**.
  • Participants who have not received a specific type of chemotherapy called **platinum-based cCRT**.
  • Participants whose cancer has worsened after receiving the specific chemotherapy.
  • Participants who are under the age of 18.
  • Participants who are unable to give informed consent.
  • Participants who are pregnant or breastfeeding.
  • Participants with other serious health conditions that could interfere with the study.
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Investigated drugs

  • Durvalumab

    is a medication used in this trial to help the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the immune system to better target and destroy them. This medication is being tested to see if it can improve outcomes for patients with a specific type of lung cancer that has not progressed after initial treatment.

  • Domvanalimab (AB154)

    is another medication being studied in this trial. It is designed to enhance the body's immune response against cancer cells. By targeting certain pathways in the immune system, it aims to boost the ability of immune cells to recognize and attack cancer cells. This medication is being combined with durvalumab to see if the combination is more effective than durvalumab alone in treating lung cancer.

What is already known about the treatment

  • Durvalumab

    Durvalumab is administered as an intravenous infusion and is currently used in clinical settings for treating certain types of cancer, including non-small cell lung cancer (NSCLC). It is approved for use in patients whose disease has not progressed following platinum-based chemoradiation therapy. The medication works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells. Durvalumab is classified as an immune checkpoint inhibitor.

  • Domvanalimab

    Domvanalimab is also administered intravenously and is being studied in clinical trials for its potential use in treating cancer, specifically in combination with other therapies like durvalumab. It is not yet widely used in standard medical practice. Domvanalimab targets the TIGIT protein, which is involved in immune regulation, aiming to enhance the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. NSCLC is often diagnosed at an advanced stage, where the cancer has spread locally but cannot be surgically removed. The progression of NSCLC can vary, but it typically involves the growth and spread of cancer cells to nearby tissues and possibly to other parts of the body. The expression of certain proteins, like PD-L1, can influence the behavior of the cancer and its response to treatments.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506891-28-00Protocol codeD9075C00001Estimated enrolment860 patientsSponsorAstraZeneca AB

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