Study on Radiotherapy and Durvalumab for Patients with Resectable Stage III Non-Small Cell Lung Cancer (NSCLC)

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC), specifically in patients with a form that can potentially be removed by surgery. The study is investigating the effects of combining different treatments to see if they can improve outcomes for patients. The treatments being studied include a combination of chemotherapy drugs, cisplatin and docetaxel, and an immune therapy drug called durvalumab (also known by its code name MEDI4736). Additionally, the study will explore the use of radiotherapy, which is a treatment that uses high-energy rays to target and kill cancer cells.

The purpose of the study is to evaluate whether adding radiotherapy to the standard chemotherapy and immune therapy can be effective and manageable for patients with this type of lung cancer. Participants in the study will receive these treatments before undergoing surgery to remove the cancer. The study will monitor how well the cancer responds to the treatments and how the treatments affect the patients’ health and recovery.

Throughout the study, patients will receive the treatments in a controlled manner, with careful monitoring by healthcare professionals. The study aims to gather information on the safety and effectiveness of this combined treatment approach, with the hope of improving the chances of successful surgery and long-term health for patients with advanced NSCLC.

1 initial treatment phase

The treatment begins with neoadjuvant chemotherapy, which is chemotherapy given before surgery to shrink the tumor. This phase involves the administration of two drugs: cisplatin and docetaxel. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The specific dosage and frequency of these medications will be determined by the healthcare provider based on individual health conditions and response to treatment.

2 immune therapy phase

Following the initial chemotherapy, durvalumab, an immune therapy drug, is administered. Durvalumab is an anti-PD-L1 antibody, which helps the immune system recognize and attack cancer cells more effectively.

This medication is also given through an intravenous infusion. The duration and frequency of administration will be specified by the healthcare provider.

3 radiotherapy phase

In this phase, immune-modulatory radiotherapy is used to enhance the effects of the immune therapy. Radiotherapy involves the use of high-energy rays to target and kill cancer cells.

The schedule and dosage of radiotherapy will be determined by the healthcare team based on the specific characteristics of the cancer and the patient’s overall health.

4 surgical phase

After completing the chemotherapy, immune therapy, and radiotherapy, surgery is performed to remove the tumor. The goal is to achieve a complete resection, meaning all visible cancer is removed.

The timing of the surgery will depend on the patient’s response to the previous treatments and their overall health status.

5 post-surgical follow-up

Following surgery, regular follow-up appointments are scheduled to monitor recovery and check for any signs of cancer recurrence. These appointments may include physical exams, imaging tests, and laboratory tests.

The healthcare team will provide specific instructions on the frequency and type of follow-up care needed.

Who Can Join the Study?

The patient must have a type of lung cancer called non-small cell lung cancer (NSCLC) that can be surgically removed and is locally advanced.
The lung cancer must be confirmed through a test called histology (or cytology if histology is not possible). This means examining the cells under a microscope to confirm the type of cancer.
The cancer can be of different types: adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or NSCLC not otherwise specified. It doesn’t matter if there are specific genetic changes or the level of a protein called PD-L1.
The cancer must be at a specific stage, called T1-4>7 N2 M0, according to a system called the TNM classification. This system helps describe the size and spread of cancer. The cancer should not have spread to other parts of the body.
The patient must be between 18 and 75 years old at the time of joining the study.
The patient must have a WHO performance status of 0-1, which means they are fully active or have some symptoms but can still carry out light work.
The patient must have adequate organ function, including a kidney function test result called eGFR that is 60 mL/min or higher.

Who Cannot Join the Study?

Patients who have a different type of lung cancer than the one being studied.
Patients who have cancer that cannot be surgically removed.
Patients who have already received certain treatments for their lung cancer.
Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures for any reason.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.03.2024

Trial locations

Investigated drugs:

Cisplatin is a chemotherapy medication used to treat various types of cancer, including lung cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. In this trial, it is used as part of the standard neoadjuvant chemotherapy regimen.

Docetaxel is another chemotherapy drug that is used to treat lung cancer. It works by interfering with the microtubule structures within the cell, which are essential for cell division. This helps to stop the growth and spread of cancer cells. It is used alongside cisplatin in the neoadjuvant chemotherapy treatment.

Durvalumab is an immunotherapy drug that targets the PD-L1 protein on cancer cells. By blocking this protein, durvalumab helps the immune system recognize and attack cancer cells more effectively. In this trial, it is used as a peri-operative treatment to enhance the effects of chemotherapy and radiotherapy.

Immune-modulatory radiotherapy is a type of radiation treatment that not only targets cancer cells directly but also aims to stimulate the immune system to attack cancer cells. In this trial, it is used to enhance the effects of the neoadjuvant chemotherapy and immunotherapy with durvalumab.

Investigated diseases:

Non-small cell lung cancer stage III

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the tissues of the lung. NSCLC is often diagnosed at an advanced stage, where the cancer has spread to nearby lymph nodes (N2 stage). The disease progresses as the cancer cells continue to grow and potentially spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and difficulty breathing. The progression can vary significantly depending on the stage at diagnosis and other individual factors.

Trial ID:

2023-504536-18-00

Protocol code:

SAKK 16/18

NCT ID:

NCT04245514

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Radiotherapy and Durvalumab for Patients with Resectable Stage III Non-Small Cell Lung Cancer (NSCLC)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?