Recruiting

Study on Durvalumab and Radiotherapy for Patients with Early-Stage 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 a type of lung cancer known as early-stage non-small cell lung cancer (NSCLC). The treatment being tested involves a combination of two approaches: a medication called durvalumab and a specific type of radiation therapy. Durvalumab, also known by its code name MEDI4736, is given as an infusion, which means it is administered directly into the bloodstream through a vein. The purpose of the study is to evaluate the safety and effectiveness of this treatment combination in preparing the body for surgery by modifying the tumor environment.

Participants in the study will receive a single fixed dose of durvalumab along with a carefully adjusted schedule of radiation therapy. This is known as a neoadjuvant treatment, which means it is given before the main treatment, in this case, surgery. The study aims to see how well the cancer responds to this combination before surgery and to ensure that it is safe for patients. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects.

The trial will monitor the safety of the treatment by observing any side effects experienced by participants. It will also assess how the cancer responds to the treatment by examining the tumor tissue after it is surgically removed. The study will look at changes in the tumor's immune environment and use imaging techniques like PET scans to evaluate the response. The trial is expected to continue until 2025, with the goal of improving treatment strategies 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.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes a review of medical history and a series of tests to ensure all criteria are met.
Tests may include blood tests, imaging scans, and lung function tests to evaluate overall health and suitability for the trial.
Step 2
Medication administration
You will receive a single fixed dose of durvalumab, which is a medication given through an intravenous (IV) infusion. The dose is 1500 mg.
The infusion will be administered in a healthcare setting, and medical staff will monitor you during and after the infusion to ensure safety.
Step 3
Radiotherapy
Following the medication, you will undergo a short course of medium-dose radiotherapy. This is a treatment that uses high-energy rays to target and treat the tumor.
The schedule for radiotherapy will be adaptive, meaning it may be adjusted based on your specific needs and response to treatment.
Step 4
Surgery preparation
After completing the medication and radiotherapy, preparations for surgery will begin. This involves additional assessments to ensure you are ready for the procedure.
The surgery aims to modify the tumor environment and will be planned based on your response to the previous treatments.
Step 5
Surgery
The surgical procedure will be performed to remove the tumor. The timing and specifics of the surgery will be determined by your healthcare team.
Post-surgery, you will be monitored closely to manage recovery and assess the outcomes of the treatment.
Step 6
Follow-up
Regular follow-up appointments will be scheduled to monitor your health and the effects of the treatment over time.
These appointments may include physical exams, imaging tests, and discussions about any side effects or concerns you may have.

Who can join the trial?

16 criteria

Must have a histologically confirmed NSCLC (a type of lung cancer confirmed by examining tissue under a microscope).
Must have a tumor classified as T1c-3N0-2 (a specific stage of lung cancer based on size and spread, but not invading certain areas like the chest wall or diaphragm).
Must be willing and able to provide written informed consent (agree in writing to participate after understanding the study).
Must be above 18 years of age on the day of signing the informed consent.
Must have measurable disease based on RECIST 1.1 (a standard way to measure how cancer responds to treatment).
Must have an ECOG performance status of 0-1 (a scale to assess how well a person can perform daily activities) and be considered operable based on lung function tests.
Must demonstrate adequate organ function as acceptable for immunotherapy, including:
- Leukocytes (white blood cells) ≥ 3,000/mm³
- Absolute neutrophil count (ANC) ≥ 1000/mm³
- Platelet count ≥ 75,000/mm³
- Hemoglobin ≥ 6 mmol/L (9.7 g/dL)
- Creatinine ≤ 1.5 times the upper limit of normal or creatinine clearance (CrCl) ≥ 40 mL/min
- Total Bilirubin ≤ 1.5 times the upper limit of normal (except for those with Gilbert Syndrome)
- AST and ALT ≤ 2.5 times the upper limit of normal
- Adequate lung function for surgery, determined by lung function tests
- Must have a body weight greater than 30 kg (about 66 pounds).
- Must have a life expectancy of at least 12 weeks.

Who cannot join the trial?

3 criteria

Patients with any medical condition other than early stage NSCLC (a type of lung cancer) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection, cannot participate.

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Verified sites

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Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Stichting OLVG
Verified
Amsterdam, The Netherlands

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Investigated drugs

Durvalumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, durvalumab is given to patients before surgery to see if it can help shrink the tumor and make it easier to remove. The goal is to use the body's own defenses to fight the cancer more effectively.

Radiotherapy is a treatment that uses high-energy rays to target and kill cancer cells. In this trial, a special type of radiotherapy is used before surgery. The idea is to give a lower dose of radiation over a short period to help change the environment around the tumor, making it more vulnerable to treatment. This approach aims to improve the chances of successfully removing the cancer during surgery.

Durvalumab

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its use in treating early-stage non-small cell lung cancer (NSCLC). The main therapeutic indication for durvalumab in this trial is to modify the tumor microenvironment before surgery. At the molecular level, durvalumab works by blocking a protein called PD-L1, which helps the immune system recognize and attack cancer cells. It is classified as an immunotherapy drug, specifically a checkpoint inhibitor, which helps the body's immune system fight cancer.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – Non-Small Cell Lung Cancer is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It generally starts in the epithelial cells lining the lungs and can grow and spread to other parts of the body. The disease progresses through stages, beginning with localized tumors and potentially advancing to involve lymph nodes and distant organs. Early stages may not cause noticeable symptoms, but as it progresses, symptoms like persistent cough, chest pain, and shortness of breath can occur. The rate of progression can vary, with some cases remaining stable for extended periods while others advance more rapidly.