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Study of Durvalumab and Chemotherapy for Patients with Resectable Non-Small Cell Lung Cancer

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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 the treatment of Non-Small Cell Lung Cancer (NSCLC), specifically in patients with stages II and III of the disease. The study involves the use of a medication called Durvalumab, also known by its code name MEDI4736. Durvalumab is an immunotherapy drug that helps the immune system fight cancer. The trial will also involve various chemotherapy drugs, including Cisplatin, Carboplatin, Gemcitabine, Gemcitabine Hydrochloride, Pemetrexed, Pemetrexed Disodium, Paclitaxel, Infliximab, and Mycophenolate Mofetil. These medications will be administered to patients before and after surgery to remove the cancer.

The purpose of the study is to compare the effectiveness of Durvalumab combined with chemotherapy to a placebo combined with chemotherapy. The study will assess how well the treatment works in terms of event-free survival (EFS), which means the length of time patients remain free from certain complications or events related to cancer. It will also look at the pathological complete response (pCR), which refers to the absence of cancer cells in tissue samples after treatment. Patients will receive the treatment intravenously, meaning it will be given through a vein, and the study will follow their progress over time.

Participants in the study will undergo treatment both before and after their cancer surgery. The study aims to provide valuable information on whether adding Durvalumab to the standard chemotherapy regimen can improve outcomes for patients with operable NSCLC. The trial is expected to continue until 2028, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatment.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Tests are performed to confirm the diagnosis of non-small cell lung cancer and to assess the stage of the disease.

  2. Step 2

    Pre-surgery treatment

    The treatment begins with a combination of durvalumab and chemotherapy. This phase is known as neoadjuvant therapy.

    Durvalumab is administered intravenously. The chemotherapy may include drugs such as cisplatin, gemcitabine, carboplatin, paclitaxel, or pemetrexed, also given intravenously.

    The duration and frequency of this treatment depend on the specific protocol of the study.

  3. Step 3

    Surgery

    After completing the pre-surgery treatment, surgery is performed to remove the lung tumor. The type of surgery may include lobectomy, sleeve resection, or bilobectomy.

  4. Step 4

    Post-surgery treatment

    Following surgery, the treatment continues with durvalumab as adjuvant therapy. This phase aims to eliminate any remaining cancer cells.

    Durvalumab is administered intravenously, similar to the pre-surgery phase.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up visits are scheduled to monitor recovery and assess the effectiveness of the treatment.

    These visits may include physical examinations, imaging tests, and laboratory tests to evaluate the patient's health status and detect any signs of cancer recurrence.

Who can join the trial?

10 criteria

  • Must be at least 18 years old.
  • Must have a lung function test result called FEV of 1.0 L or more, and more than 40% of the expected value after surgery. FEV is a test that measures how much air you can blow out of your lungs.
  • Must have been newly diagnosed and not previously treated for a type of lung cancer called Non-small Cell Lung Cancer (NSCLC) that can be surgically removed. The cancer should be in stages IIA to IIIB.
  • Must have a World Health Organization (WHO)/ECOG Performance Status of 0 or 1. This is a scale that measures how well you can perform daily activities.
  • Must have at least one tumor that has not been treated with radiation and qualifies as a RECIST 1.1 Target Lesion at the start of the study. This means the tumor can be measured to see if it changes during the study.
  • Must not have had any previous treatment with immune-based therapies, such as certain antibodies or cancer vaccines.
  • Must have adequate organ and bone marrow function. This means your organs and bone marrow are working well enough to participate in the study.
  • Must have confirmation of the tumor's PD-L1 status. PD-L1 is a protein that can affect how the immune system responds to cancer.
  • Must provide a sufficient sample of the tumor for testing to confirm EGFR and ALK status. These are specific genes that can affect cancer growth.
  • Must have planned surgery that includes lobectomy, sleeve resection, or bilobectomy. These are types of surgeries to remove parts of the lung.

Who cannot join the trial?

10 criteria

  • Patients with other types of lung cancer that are not classified as **Non-small Cell Lung Cancer**.
  • Patients with lung cancer that is not in **Stage IIA to IIIB**. This means the cancer must be in a specific range of stages to participate.
  • Patients who have already had surgery to remove their lung cancer.
  • Patients who are not able to have surgery for their lung cancer.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are not willing to use effective birth control during the study.
  • Patients who have participated in another clinical trial recently.
  • Patients who have had an allergic reaction to similar medications in the past.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

  • Durvalumab

    is a medication used in this clinical trial to help treat patients with certain types of lung cancer. It is given to patients before and after surgery to see if it can improve the chances of the cancer not coming back. Durvalumab works by helping the immune system recognize and attack cancer cells more effectively.

  • Chemotherapy

    is a treatment that uses special drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy is given to patients before surgery to help shrink the tumor and make it easier to remove. The goal is to see if combining chemotherapy with durvalumab can improve treatment outcomes for patients with lung cancer.

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, typically given in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating resectable non-small cell lung cancer, specifically in stages IIA to IIIB. The main therapeutic indication for durvalumab is to enhance the immune system's ability to fight cancer by blocking a protein called PD-L1, which helps cancer cells evade immune detection. This medication is classified as an immune checkpoint inhibitor, a type of immunotherapy that helps the body's immune system recognize and attack cancer cells more effectively.

Investigated diseases

Non-small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as squamous cell carcinoma and adenocarcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. The disease is staged from I to IV, with stages IIA to IIIB indicating that the cancer is locally advanced but may still be resectable, meaning it can potentially be removed through surgery. As the disease progresses, it can spread to nearby lymph nodes and other parts of the body. Symptoms may include persistent cough, chest pain, and difficulty breathing. Early detection and intervention are crucial for managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509576-42-00Protocol codeD9106C00001Estimated enrolment883 patientsSponsorAstraZeneca AB

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