Algemeen Ziekenhuis Delta
Roeselare, Belgium
Not recruiting
Study of Durvalumab and Tremelimumab for Patients with Limited Stage Small-Cell Lung Cancer After Chemoradiation Therapy
Verified siteRegistered drug
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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 treatments for Limited Stage Small-Cell Lung Cancer (LS-SCLC). The study will explore the effectiveness of two medications, Durvalumab and Tremelimumab, either used together or with a placebo. Durvalumab is also known by its code name MEDI4736. The purpose of the study is to evaluate how well these treatments work in patients who have not experienced disease progression after receiving a combination of chemotherapy and radiation therapy.
Participants in the study will receive one of the following treatments: Durvalumab alone, a combination of Durvalumab and Tremelimumab, or a placebo. The medications are administered as a solution for infusion, which means they are given directly into the bloodstream through a vein. The study will last for a period of up to 24 months, during which the effects of the treatments will be monitored and compared.
The trial aims to provide valuable information on the potential benefits of these treatments for patients with Limited Stage Small-Cell Lung Cancer. By participating in this study, researchers hope to determine if these medications can help improve the outcomes for patients who have already undergone initial treatment with chemotherapy and radiation. The study is conducted in a double-blind manner, meaning neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
11 criteria
- Patients must have **Limited Stage Small-Cell Lung Cancer (LS-SCLC)**, which means the cancer is in a limited area and can be treated with radiation.
- The cancer must be confirmed through a test called **histology** or **cytology**, which examines cells or tissues under a microscope.
- Patients should have received a specific type of treatment called **chemoradiotherapy**, which combines chemotherapy and radiation therapy.
- The chemotherapy must include a drug called **platinum** and another drug called **etoposide**, given through a vein (IV).
- Radiation therapy should have started by the end of the second cycle of chemotherapy and must meet specific dose requirements.
- Patients must have shown a positive response to the treatment, such as complete response (CR), partial response (PR), or stable disease (SD), and the cancer should not have worsened.
- Patients need to have a **performance status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
- A sample of the tumor must be available for testing, which can be obtained through various methods like a needle biopsy.
- Patients can be of any gender.
- Patients must be within the age range specified by the study.
- Patients from vulnerable populations may be included in the study.
Who cannot join the trial?
8 criteria
- Patients who have a different type of cancer other than Limited Stage Small-Cell Lung Cancer (LS-SCLC) cannot participate. LS-SCLC is a specific type of lung cancer that is still in its early stages.
- Individuals who are not within the specified age range for the study are excluded. The study has specific age requirements that participants must meet.
- Participants who are not able to follow the study procedures or who have conditions that might interfere with the study results are not eligible.
- People who are part of a vulnerable population, which means they might need special protection or care, are not allowed to join the study.
- Anyone who has a medical condition or is taking medication that could affect the study's outcome cannot participate.
- Individuals who have previously received certain treatments that might interfere with the study are excluded.
- Participants who are pregnant or breastfeeding are not eligible to join the study.
- People who have a history of severe allergic reactions to any of the study medications are not allowed to participate.
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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Verified Responsive Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, BelgiumResponsive Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany
Trial locations
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Investigated drugs
Durvalumab
is a medication used in this clinical trial as a consolidation treatment for patients with limited-stage small-cell lung cancer. It is being tested to see if it can help prevent the cancer from progressing after the patients have received chemoradiation therapy. Durvalumab works by helping the immune system recognize and attack cancer cells more effectively.
Tremelimumab
is another medication being studied in combination with Durvalumab in this trial. It is also used as a consolidation treatment for small-cell lung cancer. Tremelimumab is designed to enhance the body's immune response against cancer cells, potentially improving the effectiveness of the treatment when used alongside Durvalumab.
What is already known about the treatment
Durvalumab – Durvalumab is administered as an intravenous infusion and is currently being studied in clinical trials for its effectiveness in treating patients with limited stage small-cell lung cancer (LS-SCLC) who have not progressed following concurrent chemoradiation therapy. It is classified as an immune checkpoint inhibitor, specifically targeting the PD-L1 protein to enhance the body's immune response against cancer cells. The main therapeutic indication for durvalumab is to improve progression-free survival (PFS) and overall survival (OS) in these patients. As an immunotherapy, it works by blocking the interaction between PD-L1 and its receptors, thereby allowing T-cells to better attack cancer cells.
Investigated diseases
Limited Stage Small-Cell Lung Cancer (LS-SCLC) – This is a type of lung cancer characterized by small cells that multiply quickly and form large tumors. It is called "limited stage" when the cancer is confined to one side of the chest and can be treated with a single radiation field. The disease progresses rapidly, often spreading to other parts of the body if not treated promptly. Symptoms may include coughing, chest pain, and difficulty breathing. As the cancer grows, it can cause additional symptoms such as weight loss and fatigue. Early detection and intervention are crucial to managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509602-29-00Protocol codeD933QC00001Estimated enrolment730 patientsSponsorAstraZeneca AB
sourced from the EU Clinical Trials Register and site verification
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