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Study of Durvalumab and Chemo-Immunotherapy for Patients with Stage III Unresectable Non-Small Cell Lung 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 lung cancer known as Non-Small Cell Lung Cancer (NSCLC), specifically in cases where the cancer is at stage III and cannot be removed by surgery. The treatment being tested in this study involves a combination of chemotherapy and a type of therapy that uses the body's immune system to fight cancer, known as immunotherapy. The specific medication used in this trial is called Durvalumab, which is given through an infusion into a vein. The purpose of the study is to evaluate the safety and tolerability of this treatment approach.

Participants in the study will first receive a combination of chemotherapy and immunotherapy. After this initial treatment, they will undergo a type of radiation therapy called reduced-dose hypofractionated radiation therapy (RT), which uses lower doses of radiation over a shorter period. Following the radiation therapy, participants will continue to receive maintenance immunotherapy with Durvalumab. The study aims to monitor any side effects and how well the treatment is tolerated over a period of six months from the start of the treatment.

This trial is open-label, meaning both the researchers and participants know what treatment is being administered. It is conducted across multiple centers, allowing for a broader range of participants. The study will help determine if this combination of treatments can be a safe and effective option for patients with stage III unresectable NSCLC.

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

    Initial assessment

    Upon joining the study, you will undergo an initial assessment to confirm your eligibility. This includes a review of your medical history and a series of tests such as CT or MRI scans to measure the extent of your non-small cell lung cancer (NSCLC).

    You will be required to provide a signed informed consent form, confirming your understanding and agreement to participate in the study.

  2. Step 2

    Chemo-immunotherapy

    You will begin with a combination of chemotherapy and immunotherapy. The immunotherapy involves the administration of durvalumab, which is given through an intravenous (IV) infusion.

    The specific dosage and frequency of durvalumab will be determined by the study protocol and your healthcare provider.

  3. Step 3

    Reduced-dose radiation therapy

    Following the initial treatment phase, you will receive reduced-dose hypofractionated radiation therapy. This involves receiving radiation in larger doses over a shorter period of time compared to traditional radiation therapy.

    The goal of this phase is to target the cancer cells while minimizing exposure to surrounding healthy tissue.

  4. Step 4

    Maintenance immunotherapy

    After completing the radiation therapy, you will continue with maintenance immunotherapy using durvalumab. This phase is designed to help maintain the response to treatment and prevent cancer progression.

    The duration and frequency of maintenance therapy will be specified by the study protocol and your healthcare provider.

  5. Step 5

    Regular monitoring

    Throughout the study, you will have regular follow-up visits to monitor your health and response to treatment. This includes physical exams, imaging tests, and blood tests.

    Your healthcare team will assess any side effects and adjust your treatment plan as necessary to ensure your safety and well-being.

  6. Step 6

    End of study

    At the end of the study, you will have a final assessment to evaluate the overall effectiveness of the treatment and any long-term effects.

    You will receive guidance on the next steps for your care and any additional follow-up that may be required.

Who can join the trial?

17 criteria

  • Must be able to give signed informed consent, which means you understand the study and agree to follow its rules.
  • Body weight must be more than 30 kg (about 66 pounds) at the time of joining the study.
  • Can be male or female.
  • If you are a woman, you must either be post-menopausal (no periods for 12 months without another medical reason) or have a negative pregnancy test if you are premenopausal. If you can become pregnant, you must agree to use two methods of birth control during the study and for 3 months after the last dose of the study drug. If you are a man who can father children, you must also agree to use two methods of birth control during the study.
  • Must provide a signed and dated written consent form before any study-specific procedures, sampling, and analyses.
  • Must be 18 years or older at the time of signing the consent form.
  • Must have a confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced and cannot be removed by surgery. Certain imaging tests like PET/CT, MRI of the brain, and endobronchial ultrasound with biopsy are encouraged at diagnosis.
  • Must have measurable disease as assessed by CT or MRI at the start of the study.
  • Must have a life expectancy of at least 12 weeks at the time of joining the study.
  • Must have a WHO/ECOG Performance Status of 0-1, which means you are fully active or have some symptoms but can still carry out light work.
  • Must not be eligible for concurrent chemo radiation according to the investigator's assessment.
  • Must have adequate organ and bone marrow function at the time of joining the study, which includes:
    • Hemoglobin level of at least 9.0 g/dL.
    • Absolute neutrophil count greater than 1.0 x 109/L.
    • Platelet count greater than 75 x 109/L.
    • Serum bilirubin level no more than 1.5 times the upper limit of normal, except for patients with confirmed Gilbert’s syndrome.
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels no more than 2.5 times the upper limit of normal.
    • Creatinine clearance greater than 40 mL/min, which is a measure of kidney function.

Who cannot join the trial?

4 criteria

  • Patients with any other type of cancer besides Non-Small Cell Lung Cancer cannot participate.
  • Patients who have experienced severe side effects (known as Grade 3 or Grade 4 adverse events) from similar treatments in the past are not eligible.
  • Patients who are under the age of 18 or over the age of 65 are not eligible to participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.
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Investigated drugs

  • Chemo-immunotherapy

    is a combination treatment that uses both chemotherapy and immunotherapy to fight cancer. Chemotherapy involves using drugs to kill or slow the growth of cancer cells, while immunotherapy helps boost the body's natural defenses to fight the cancer. This combination aims to enhance the effectiveness of treatment by attacking the cancer in multiple ways.

  • Reduced-dose hypofractionated RT

    refers to a type of radiation therapy where a lower total dose of radiation is given in larger doses over a shorter period. This approach is designed to target the cancer more precisely, potentially reducing side effects and improving the patient's quality of life during treatment.

  • Maintenance immunotherapy

    is a treatment given after the initial therapy to help keep the cancer under control. It involves using medications that help the immune system continue to fight cancer cells, aiming to prevent the cancer from coming back or growing further.

What is already known about the treatment

Chemo-immunotherapy – This treatment is administered through intravenous infusion, meaning it is given directly into the bloodstream through a vein. Currently, chemo-immunotherapy is being studied in clinical trials for its effectiveness in treating stage III unresectable Non-Small Cell Lung Cancer (NSCLC). The main goal of this therapy is to use the body's immune system to help fight cancer cells, while chemotherapy targets and kills rapidly dividing cells. At the molecular level, immunotherapy works by enhancing the immune system's ability to recognize and destroy cancer cells, while chemotherapy disrupts the cancer cell's ability to grow and divide. This combination is classified under both chemotherapy and immunotherapy, aiming to improve patient outcomes by using the strengths of both approaches.

Investigated diseases

Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer is a type of lung cancer that begins in the tissues of the lung, typically in the cells lining the air passages. It is the most common type of lung cancer, accounting for a majority of cases. The disease progresses as cancer cells grow and form a tumor, which can invade nearby tissues and spread to other parts of the body. As it advances, symptoms such as persistent cough, chest pain, and difficulty breathing may occur. The progression can vary, with some tumors growing slowly over time, while others may spread more rapidly. The disease is categorized into stages based on the size of the tumor and the extent of its spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518408-32-00Protocol codeDEDALUSEstimated enrolment45 patientsSponsorFondazione IRCCS Policlinico San Matteo

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