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Study on the Effects of Adding Durvalumab After Chemotherapy and Surgery in 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 effects of adding a medication called durvalumab after initial treatment in patients with early-stage, operable non-small cell lung cancer (NSCLC). The study aims to understand if this additional treatment can improve the time patients remain free from cancer after surgery. The initial treatment involves a combination of chemotherapy and durvalumab, followed by surgery to remove the cancer.

Participants in the study will receive treatments through an intravenous infusion, which means the medication is given directly into a vein. The medications used in the study include cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, which are all types of chemotherapy drugs. These drugs work by targeting and killing cancer cells. The study will also use durvalumab, an immunotherapy drug that helps the immune system recognize and attack cancer cells.

The study will take place over a period of time, with participants receiving treatment for up to 16 weeks. The goal is to determine if adding durvalumab after the initial treatment can help prevent the cancer from returning. Participants will be monitored throughout the study to assess their response to the treatment and any side effects they may experience. The study is designed to provide valuable information on improving treatment outcomes for patients with early-stage 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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as confirmed non-small cell lung cancer (NSCLC), resectable and operable primary tumor, and adequate organ function.

    The patient must be fit to receive platinum-based chemotherapy and have a known PD-L1 status without certain genetic mutations.

  2. Step 2

    Neoadjuvant treatment phase

    The patient receives a combination of chemotherapy and immunotherapy before surgery. This includes drugs like cisplatin, carboplatin, gemcitabine hydrochloride, and durvalumab administered through intravenous infusion.

    The goal is to reduce the tumor size and improve surgical outcomes.

  3. Step 3

    Surgery

    After the neoadjuvant treatment, surgery is performed to remove the tumor.

    The surgical outcome is assessed to determine if the tumor has been completely removed.

  4. Step 4

    Randomisation

    Following surgery, patients are evaluated for randomisation based on their response to the initial treatment.

    Patients are then randomly assigned to receive either additional treatment or standard follow-up care.

  5. Step 5

    Adjuvant treatment phase

    Patients who are selected for additional treatment receive durvalumab as an adjuvant therapy to help prevent cancer recurrence.

    This phase aims to improve disease-free survival and overall survival rates.

  6. Step 6

    Follow-up

    Regular follow-up visits are scheduled to monitor the patient's health and response to treatment.

    The study tracks outcomes such as disease-free survival, overall survival, and any side effects experienced.

Who can join the trial?

11 criteria

  • The patient must have a type of lung cancer called **non-small cell lung cancer (NSCLC)**, confirmed by a test called a **histology**.
  • The main tumor must be able to be removed by surgery and the patient must be healthy enough for the surgery, as decided by a team of doctors.
  • The patient must be able to receive a specific type of chemotherapy that includes a drug called **platinum**, according to local medical standards.
  • The cancer must be at a specific stage, called **Stage IIB-IIIB**, based on a system that measures the size and spread of the cancer. For Stage III, certain lymph nodes must be checked to ensure the cancer has not spread too far.
  • The patient must have a known status of a protein called **PD-L1**, determined by a local test.
  • The patient must not have certain genetic changes in the cancer, specifically no **EGFR mutation** or **ALK translocation**, as tested locally.
  • The patient must have normal blood, kidney, and liver function.
  • The patient must have a performance status of 0-1 on a scale called the **Eastern Cooperative Oncology Group (ECOG)**, which measures how well the patient can perform daily activities.
  • The patient must be at least 18 years old at the time of joining the study.
  • The patient must weigh more than 30 kilograms.
  • The patient must have a life expectancy of at least 12 weeks.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not the specific type being studied, which is a certain stage of lung cancer.
  • Patients who have had a different type of treatment that is not part of the study plan.
  • Patients with serious health conditions that might make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study might affect the baby.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have participated in another clinical trial recently, which might interfere with this study.
  • Patients with allergies or reactions to the study medications or similar drugs.
  • Patients with certain infections that could affect their health during the study.
  • Patients with a history of drug or alcohol abuse that might affect their ability to participate.
  • Patients who have had an organ transplant, as their immune system might be affected.
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Investigated drugs

Durvalumab is an immunotherapy medication used in this clinical trial. It is designed to help the body's immune system recognize and attack cancer cells more effectively. In this study, durvalumab is given to patients after they have received initial treatment with chemotherapy and durvalumab, to see if it can improve the time patients remain free from 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 certain types of lung cancer, specifically stage IIB-IIIB resectable non-small cell lung cancer (NSCLC). The main therapeutic indication for Durvalumab is to serve as an adjuvant treatment following neoadjuvant chemotherapy and immunotherapy, aiming to improve disease-free survival in patients. At the molecular level, Durvalumab works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immunotherapy drug, specifically a checkpoint inhibitor.

Investigated diseases

Stage IIB-IIIB (N2) Resectable Non-Small Cell Lung Cancer – This is a type of lung cancer that is categorized by its ability to be surgically removed and its specific stage of progression. In Stage IIB, the cancer has spread to nearby lymph nodes or structures, while Stage IIIB indicates further spread to lymph nodes on the opposite side of the chest or above the collarbone. The term "N2" refers to the involvement of lymph nodes in the center of the chest, which can complicate surgical removal. This cancer type is known for its potential to grow and spread to other parts of the body if not treated. The progression of the disease can vary, with some patients experiencing more rapid advancement than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508773-82-00Protocol codeETOP25-23 ADOPT-lungEstimated enrolment580 patientsSponsorETOP IBCSG Partners Foundation

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