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Study on Thoracic Radiotherapy and Durvalumab for Elderly or Frail Stage III Non-Small Cell Lung Cancer Patients Unable to Undergo Chemotherapy

Fast replyRegistered 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 patients with stage III of the disease that cannot be removed by surgery. The treatment being tested is a combination of Durvalumab, also known by its code name MEDI4736, and a specialized form of radiation therapy. Durvalumab is a medication given through an infusion, which means it is delivered directly into the bloodstream through a vein. The study is designed for elderly and/or frail patients who are not suitable for chemotherapy.

The purpose of the study is to evaluate the safety and effectiveness of combining Durvalumab with two different types of radiation therapy. One type is the conventional method, and the other is an optimized method called hypofractionated radiotherapy, which involves giving larger doses of radiation over a shorter period. The study aims to see how well these treatments work together in improving the response rates in patients with this type of lung cancer.

Participants in the study will receive either the conventional or the hypofractionated radiation therapy along with Durvalumab. The study will monitor the safety of these treatments and how well they are tolerated by the patients. It will also look at how the cancer responds to the treatment over time. The study is expected to last for a period of up to 12 months, during which patients will have regular hospital visits for treatment and follow-up examinations.

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, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a series of tests to ensure adequate bone marrow, renal, and hepatic function.

    A pregnancy test is required for women of reproductive potential. Post-menopausal status is verified for applicable participants.

  2. Step 2

    Treatment planning

    A treatment plan is developed, which includes thoracic radiotherapy and the administration of durvalumab. The radiotherapy may be either conventionally fractionated or hypofractionated, depending on the specific group assignment.

  3. Step 3

    Radiotherapy

    Radiotherapy is administered to the chest area. The schedule and dosage depend on whether the treatment is conventionally fractionated or hypofractionated.

  4. Step 4

    Durvalumab administration

    Durvalumab is given as an intravenous infusion. The concentration is 50 mg/mL, and it is prepared as a solution for infusion. The frequency and duration of administration are determined by the study protocol.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes checking for any side effects, particularly treatment-related pneumonitis.

    Follow-up visits are scheduled to evaluate the response to treatment and to monitor overall health status.

  6. Step 6

    Completion and evaluation

    Upon completion of the treatment phase, a final evaluation is conducted to assess the overall response to the therapy.

    The study aims to conclude by December 31, 2025, with ongoing assessments of treatment efficacy and safety.

Who can join the trial?

21 criteria

  • The patient must provide fully-informed written consent and any required local authorization before any study-related procedures are performed.
  • The patient must have at least one measurable site of disease as defined by specific medical criteria (RECIST 1.1).
  • The patient must have adequate bone marrow and kidney function, which includes:
    • Hemoglobin level of at least 9.0 grams per deciliter (g/dL).
    • Absolute neutrophil count of at least 1.0 x 109 per liter (L).
    • Platelet count of at least 75 x 109 per liter (L).
    • Creatinine clearance (a measure of kidney function) of at least 30 milliliters per minute (mL/min).
    • The patient must have adequate liver function, which includes:
      • Serum bilirubin level no more than 1.5 times the normal upper limit.
      • AST (a liver enzyme) and ALT (another liver enzyme) levels no more than 2.5 times the normal upper limit.
      • Female patients who can have children must have a negative pregnancy test within 7 days before starting the trial.
      • Female patients must show evidence of being post-menopausal or have a negative pregnancy test if they are pre-menopausal. Post-menopausal status is defined by specific criteria related to age and medical history.
      • The patient must be willing and able to follow the study protocol, including attending hospital visits for treatment and follow-up examinations.
      • The patient must be at least 18 years old.
      • The patient must have a confirmed diagnosis of unresectable stage III non-small-cell lung cancer (NSCLC).
      • The patient must not be suitable for sequential chemotherapy and radiotherapy, as determined by a team of medical specialists or the investigator.
      • The patient must meet at least one of the following criteria:
        • Performance status of 2 on a specific scale (ECOG scale).
        • Performance status of 1 on the ECOG scale and a Charlson Comorbidity Index (CCI) of at least 1.
        • Age of 70 years or older.
        • The patient must have a life expectancy of at least 12 weeks.
        • The patient must have a lung function test result (FEV1) of at least 40% of the expected value.
        • The patient must have a lung diffusion capacity test result (DLCO or DLCO/VA) of at least 40% of the expected value.
        • The patient must have a lung volume test result (FVC or VC) of at least 70% of the expected value.

Who cannot join the trial?

8 criteria

  • Patients who have had surgery to remove the lung cancer cannot participate. This means the cancer must be unresectable, which means it cannot be removed by surgery.
  • Patients who are suitable for chemotherapy are not eligible. This study is for those who cannot have chemotherapy.
  • Patients with medical conditions that make it unsafe to receive the study treatments cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible to join the study.
  • Patients who have another type of cancer that requires treatment are not eligible.
  • Patients who have had a severe allergic reaction to similar treatments in the past cannot participate.
  • Patients with certain heart conditions that could be worsened by the study treatments are not eligible.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate.
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Investigated drugs

  • Durvalumab

    is a medication used in this trial to help the body's immune system fight cancer. It is an immunotherapy drug that targets a specific protein on cancer cells, helping the immune system to recognize and attack these cells more effectively. In this trial, it is combined with radiotherapy to see if it improves the treatment outcomes for patients with stage III non-small cell lung cancer (NSCLC) who cannot undergo chemotherapy.

  • Thoracic Radiotherapy

    is a type of cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors in the chest area. In this trial, two different methods of delivering radiotherapy are being tested: conventionally fractionated radiotherapy and hypofractionated radiotherapy. The goal is to determine which method, when combined with durvalumab, is more effective and better tolerated by patients with stage III NSCLC who are not fit for chemotherapy.

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently being studied in medical trials for its effectiveness in treating unresectable stage III non-small-cell lung cancer (NSCLC) in patients who cannot undergo chemotherapy. The medication works by blocking a protein called PD-L1, which helps cancer cells evade the immune system, thereby allowing the body's immune system to better detect and attack cancer cells. Durvalumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

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. In stage III, the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body. The term "unresectable" indicates that the cancer cannot be removed completely through surgery. As the disease progresses, it may cause symptoms like persistent cough, chest pain, and difficulty breathing. Treatment often focuses on managing symptoms and slowing the progression of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513948-28-00Protocol codeTRADE-hypoEstimated enrolment57 patientsSponsorInstitut fuer Klinische Krebsforschung IKF GmbH

sourced from the EU Clinical Trials Register and site verification

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