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Study of Durvalumab, Tremelimumab, Chemotherapy, and Radiotherapy for Patients with Newly Diagnosed Non-Small Cell Lung Cancer with Limited Spread

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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) that has spread to a few other parts of the body, referred to as synchronous oligo-metastatic NSCLC. The study is exploring the effectiveness of a combination of treatments, including two medications called durvalumab (also known by its code name MEDI4736) and tremelimumab, along with chemotherapy and a type of targeted radiation therapy called stereotactic body radiotherapy (SBRT). These treatments are followed by either surgery or additional radiation therapy to the main tumor in the lung.

The purpose of this study is to evaluate how well these combined treatments work in controlling the cancer. Participants will receive the medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will monitor the participants over a period to see how the cancer responds to the treatment and to assess the overall health and quality of life of the participants. The study aims to understand how long the cancer can be kept from progressing and to gather information on the overall survival of the participants.

Throughout the study, researchers will also look at various aspects such as the pattern of disease progression, the response to the initial therapy, and any side effects experienced before and after surgery or radiation therapy. The study will help in understanding the potential benefits and risks of using this combination of treatments for patients with this specific type of lung cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment begins with the administration of two medications: durvalumab and tremelimumab. These are given as solutions for infusion, which means they are delivered directly into the bloodstream through a vein.

    The medications are administered via intravenous infusion. The specific dosage and frequency will be determined by the healthcare team based on individual patient needs and responses.

  2. Step 2

    Chemotherapy and radiotherapy

    Following the initial immunotherapy, chemotherapy is administered. The specific drugs and schedule will be provided by the healthcare team.

    Stereotactic body radiotherapy (SBRT) is applied to all metastases. This is a precise form of radiation therapy aimed at targeting cancer cells in specific areas.

  3. Step 3

    Surgery or additional radiotherapy

    After the completion of chemotherapy and SBRT, the next step involves either surgery or additional radiotherapy to the primary tumor in the lung.

    The decision between surgery and radiotherapy will depend on the patient's specific condition and the response to previous treatments.

  4. Step 4

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor the patient's health and the effectiveness of the treatment.

    Progression-free survival is assessed at one year, along with other factors such as overall survival, disease progression patterns, and quality of life.

Who can join the trial?

9 criteria

  • The patient must have a confirmed diagnosis of **NSCLC**. This stands for **Non-Small Cell Lung Cancer**.
  • The patient must have **synchronous oligo-metastatic stage IV disease**. This means the cancer has spread to a few other places in the body, with a maximum of three distant metastases, and at least one must be outside the brain for a specific treatment called **SBRT** (Stereotactic Body Radiation Therapy).
  • Initial **mediastinal staging** is recommended. This involves checking the area between the lungs, usually with a special procedure called **endobronchial ultrasound (EBUS)**, unless the lymph nodes are very small and not showing signs of cancer on scans.
  • If the patient has one single **CNS metastasis** (cancer spread to the brain) or one **adrenal metastasis** (cancer spread to the adrenal gland), it can be surgically removed before joining the study, but one metastasis outside the brain must still be available for SBRT.
  • The patient must be able to understand the study and give written consent, meaning they agree to participate and follow the study procedures.
  • The patient must be at least 18 years old.
  • The patient must have an **ECOG Performance Status** of 0-1. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to do light work.
  • The patient must have available **tumor tissue** for research purposes related to the study.
  • The patient must have adequate **blood, kidney, and liver function**. This means their blood tests show that these organs are working well enough to participate in the study.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have more than a few small areas where the cancer has spread.
  • Patients who have had a different type of treatment for their cancer recently.
  • Patients who have other serious health problems that could affect the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend appointments.
  • Patients who have allergies to the medications used in the study.
  • Patients who are participating in another clinical trial at the same time.
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Investigated drugs

  • Durvalumab

    is a type of immunotherapy used in this trial. It helps the body's immune system to detect and fight cancer cells more effectively. It is specifically used for patients with non-small cell lung cancer.

  • Tremelimumab

    is another immunotherapy medication included in the trial. It works by enhancing the immune system's ability to attack cancer cells, complementing the effects of durvalumab.

  • Chemotherapy

    involves the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used alongside other treatments to help control the spread of non-small cell lung cancer.

  • Stereotactic Body Radiotherapy (SBRT)

    is a form of radiation therapy that precisely targets cancer cells in the body. It is used in this trial to treat metastases, which are cancerous growths that have spread from the primary tumor to other parts of the body.

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 certain types of lung cancer. It is primarily used for non-small cell lung cancer (NSCLC) with oligo-metastatic conditions. Durvalumab works by blocking a protein called PD-L1, which helps the immune system detect and attack cancer cells. It is classified as an immunotherapy drug.

  • Tremelimumab

    This medication is also given intravenously and is under investigation in clinical trials for its potential benefits in lung cancer treatment. It is used in combination with other therapies for NSCLC with oligo-metastatic disease. Tremelimumab functions by inhibiting CTLA-4, a protein that downregulates the immune response, thereby enhancing the body's ability to fight cancer. It belongs to the class of immunotherapy medications.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC), Synchronous Oligo-Metastatic – This form of lung cancer is characterized by the presence of a limited number of metastatic sites at the time of diagnosis. It primarily affects the lungs but can spread to other parts of the body, such as the bones or brain. The disease progresses as cancer cells grow and potentially spread to nearby tissues and organs. In its synchronous oligo-metastatic form, the cancer has already spread to a few distant sites at the time of initial diagnosis. The progression can vary, with some patients experiencing slow growth while others may have more rapid disease advancement. Understanding the pattern of spread and growth is crucial for determining the appropriate treatment approach.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511134-12-00Protocol codeETOP 14-18 CHESSEstimated enrolment48 patientsSponsorETOP IBCSG Partners Foundation

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).