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Study on Durvalumab with Oleclumab or Monalizumab 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 treatments for patients with Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC). The study will explore the effects of combining the medication Durvalumab with either Oleclumab or Monalizumab. Durvalumab is a type of medication known as an immunotherapy, which helps the immune system fight cancer. Oleclumab and Monalizumab are also immunotherapies that work in different ways to support the immune system in targeting cancer cells.

The purpose of this study is to determine if the combination of Durvalumab with Oleclumab or Monalizumab is more effective than Durvalumab with a placebo in treating patients who have not experienced cancer progression after receiving a specific type of treatment called platinum-based concurrent chemoradiation therapy. This therapy involves using chemotherapy and radiation at the same time to treat cancer. The study will involve participants receiving these treatments through intravenous infusions, which means the medication is given directly into a vein.

Participants in the study will be monitored over a period of time to assess the effectiveness of the treatments. The study aims to provide valuable information on whether these combinations can improve outcomes for patients with this type of lung cancer. The trial will be conducted in a way that ensures the safety and well-being of all participants, with regular check-ups and assessments throughout the study period.

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.

    A tumor tissue sample is required, and the status of certain proteins and genes in the tumor is documented.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of the treatment groups: durvalumab with oleclumab, durvalumab with monalizumab, or durvalumab with a placebo.

  3. Step 3

    Treatment administration

    Durvalumab is administered as an intravenous infusion. The dosage is 50 mg/mL, and the frequency and duration are determined by the study protocol.

    Oleclumab and monalizumab are also administered intravenously, with specific dosages and schedules provided during the study.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the progression of the disease and the response to treatment.

    Progression-free survival is evaluated using specific criteria over a period of up to five years.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by May 31, 2030, with ongoing assessments and data collection until that time.

Who can join the trial?

10 criteria

  • The participant must be at least 18 years old at the time of screening.
  • The participant must have a confirmed diagnosis of **non-small cell lung cancer (NSCLC)**, which is a type of lung cancer, and must have been treated with **concurrent chemoradiotherapy (CRT)** for locally advanced, unresectable (Stage III) disease. **Concurrent chemoradiotherapy** means receiving chemotherapy and radiation therapy at the same time.
  • A sample of the tumor tissue must be provided, which was obtained before the CRT treatment.
  • The tumor must have a documented **PD-L1 status**. PD-L1 is a protein that can affect the immune system's ability to fight cancer.
  • The tumor must be documented as **EGFR and ALK wild-type**. This means the cancer does not have certain genetic mutations that are sometimes found in lung cancer.
  • The participant must not have experienced disease progression after receiving a definitive, platinum-based, concurrent chemoradiotherapy. **Platinum-based chemotherapy** is a common type of cancer treatment that uses drugs containing platinum.
  • The participant must have received at least 2 cycles of platinum-based chemotherapy along with radiation therapy.
  • The participant must have received a total radiation dose of 60 Gy, with a possible variation of 10% (between 54 Gy and 66 Gy), as part of the chemoradiation therapy. **Gy** stands for Gray, a unit of radiation dose. The radiation should be given using **intensity modulated radiation therapy (IMRT)**, which is preferred, or a **3D-conforming technique**.
  • The participant must have a **WHO performance status** of 0 or 1 at the time of randomization. This is a scale that measures the participant's general well-being and ability to carry out daily activities, where 0 means fully active and 1 means some restrictions but still able to do light work.
  • The participant must have adequate organ and bone marrow function, which means their organs and bone marrow are working well enough to handle the treatment.

Who cannot join the trial?

10 criteria

  • Patients who have had surgery to remove their lung cancer.
  • Patients whose lung cancer has spread to other parts of the body.
  • Patients who have not received prior treatment with platinum-based chemotherapy and radiation therapy.
  • Patients who have experienced progression of their lung cancer after receiving platinum-based chemotherapy and radiation therapy.
  • Patients with other types of cancer that are not lung cancer.
  • Patients with serious heart conditions or uncontrolled high blood pressure.
  • Patients with active infections that require treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who are participating in another clinical trial.
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Investigated drugs

  • Durvalumab

    is a medication used to help the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells. In this trial, it is used to treat patients with a type of lung cancer that cannot be removed by surgery.

  • Oleclumab

    is an experimental drug that is being studied to see if it can help the immune system work better against cancer. It is used in combination with durvalumab to see if it can improve the treatment of lung cancer.

  • Monalizumab

    is another experimental drug that is being tested to see if it can enhance the immune system's ability to fight cancer. It is also used with durvalumab in this trial to evaluate its effectiveness in treating lung cancer.

What is already known about the treatment

  • Durvalumab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating locally advanced, unresectable non-small cell lung cancer (NSCLC). It is an immunotherapy drug that works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. By inhibiting this protein, durvalumab enhances the body's immune response against cancer cells. It is classified as a monoclonal antibody and is used primarily in patients who have not progressed following platinum-based chemoradiation therapy.

  • Oleclumab

    Administered intravenously, oleclumab is under investigation in clinical trials for its potential to treat locally advanced, unresectable NSCLC. It targets the CD73 enzyme, which is involved in the production of adenosine, a molecule that can suppress immune responses. By inhibiting CD73, oleclumab aims to enhance the immune system's ability to attack cancer cells. It is classified as a monoclonal antibody and is being studied in combination with durvalumab to improve treatment outcomes.

  • Monalizumab

    This medication is given intravenously and is being evaluated in clinical trials for its role in treating locally advanced, unresectable NSCLC. Monalizumab targets the NKG2A receptor on immune cells, which can inhibit their activity. By blocking this receptor, monalizumab may boost the immune system's ability to fight cancer. It is a monoclonal antibody and is being tested in combination with durvalumab to assess its effectiveness in enhancing cancer treatment.

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 the most common type of lung cancer, accounting for about 85% of all cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. In its locally advanced stage (Stage III), the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body. When the cancer is unresectable, it means it cannot be removed completely through surgery. The progression of NSCLC can vary, but it often involves the gradual worsening of symptoms such as coughing, chest pain, and difficulty breathing.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503999-24-00Protocol codeD9078C00001Estimated enrolment1 689 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).