Recruiting

Study on Durvalumab with Chemoradiotherapy for Stage III Non-Small Cell Lung Cancer Patients

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 Stage III non-small cell lung cancer (NSCLC). The treatment being investigated involves a medication called Durvalumab, which is also known by its code name MEDI4736. Durvalumab is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to explore the possibility of performing surgery after patients have received high-dose chemotherapy and radiation therapy, which is a combination treatment often referred to as chemoradiotherapy. After surgery, the study will also look at whether patients can continue with Durvalumab as a follow-up treatment, known as consolidation therapy. This approach aims to see if adding surgery and Durvalumab can be a feasible treatment plan for patients with Stage III NSCLC.

Participants in the study will first undergo chemoradiotherapy. If surgery is deemed possible, it will be performed within 12 weeks after completing the chemoradiotherapy. Following surgery, patients will receive Durvalumab to help consolidate the treatment. The study will monitor the ability to perform surgery and the continuation of Durvalumab treatment, as well as any side effects or complications that may arise during the process.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Chemoradiotherapy
The initial phase involves receiving high-dose chemoradiotherapy. This treatment combines chemotherapy and radiation therapy to target cancer cells in the body.
The duration and specific schedule of this treatment will be determined by the healthcare team based on individual needs and medical condition.
Step 2
Surgery evaluation
After completing chemoradiotherapy, an evaluation will be conducted to determine the feasibility of performing surgery.
This evaluation must occur within 12 weeks following the completion of chemoradiotherapy.
Step 3
Surgery
If deemed feasible, surgery will be performed to remove any remaining cancerous tissue.
The timing of the surgery will be coordinated to ensure it occurs within the specified 12-week period post-chemoradiotherapy.
Step 4
Consolidation therapy with durvalumab
Following surgery, consolidation therapy with durvalumab will be initiated.
Durvalumab is administered as a solution for infusion, given intravenously. The specific dosage and frequency will be determined by the healthcare provider.
This phase aims to enhance the effectiveness of previous treatments and reduce the risk of cancer recurrence.
Step 5
Follow-up and monitoring
Regular follow-up appointments will be scheduled to monitor recovery and assess the effectiveness of the treatment.
During these visits, any side effects or complications will be addressed, and additional support will be provided as needed.

Who can join the trial?

6 criteria

The patient must have **Stage III non-small cell lung cancer (NSCLC)**. This is a type of lung cancer that is not small cell and is at stage III, which means it has spread to nearby tissues or lymph nodes but not to distant parts of the body.
The cancer must be confirmed through a test called **histology** or **cytology**, which involves examining cells or tissues under a microscope.
If there is a suspicion of **N2-disease**, which means cancer has spread to certain lymph nodes in the chest, a special procedure called **mediastinal invasive staging** is required. This can include tests like **EUS** (endoscopic ultrasound), **EBUS** (endobronchial ultrasound), or **mediastinoscopy** to confirm the spread before starting treatment.
The patient must have an initial recommendation from a team of doctors (MDT) for a treatment plan that includes **chemoradiotherapy (CRT)** followed by a medication called **durvalumab**.
The study is open to both male and female patients.
The study is not specifically for vulnerable populations, meaning it is not designed for groups that might need special protection or care.

Who cannot join the trial?

3 criteria

Patients who have a different type of lung cancer than Stage III non-small cell lung cancer cannot participate. This is a specific stage and type of lung cancer.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection, like children or people with certain disabilities.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Durvalumab
is a medication used in this trial to help the immune system fight cancer. It is given to patients after they have undergone surgery and chemoradiotherapy. The goal is to see if it can help prevent the cancer from coming back by boosting the body's natural defenses against cancer cells.
Chemoradiotherapy
is a combination of chemotherapy and radiation therapy used to treat cancer. In this trial, it is used as an initial treatment to shrink the tumor and kill cancer cells in patients with stage III non-small cell lung cancer (NSCLC). The aim is to make the tumor smaller and more manageable before considering surgery.
Surgery
is a procedure that may be performed after chemoradiotherapy in this trial. The purpose of the surgery is to remove any remaining cancerous tissue in the lung. The trial is investigating whether it is feasible to perform surgery within 12 weeks after the initial treatment with chemoradiotherapy.

Durvalumab

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently being studied in clinical trials for its effectiveness in treating stage III non-small cell lung cancer, particularly after chemoradiotherapy and surgery. The main therapeutic use of Durvalumab is to help the immune system fight cancer by blocking a specific protein that prevents immune cells from attacking cancer cells. It belongs to a class of medications known as immune checkpoint inhibitors, which enhance the body's immune response against cancer.

Investigated diseases

Stage III Non-Small Cell Lung Cancer – This is a type of lung cancer that is characterized by the presence of cancerous cells in the tissues of the lung. In stage III, the cancer has spread to nearby lymph nodes or other parts of the lung but not to distant body parts. The disease often progresses by growing larger or spreading to nearby structures, making it more challenging to treat. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the disease advances, it can lead to more severe respiratory issues and general health decline. The progression can vary significantly among individuals, depending on various factors such as overall health and specific cancer characteristics.