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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Agwqbuyxv Uwx	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.06.2024

Trial locations

Investigated drugs:

Durvalumab

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.

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.

Trial ID:

2024-511711-21-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?