Study of Durvalumab, Tremelimumab, Chemotherapy, and Radiotherapy for Patients with Newly Diagnosed Non-Small Cell Lung Cancer with Limited Spread

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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) that has spread to a few other parts of the body, referred to as synchronous oligo-metastatic NSCLC. The study is exploring the effectiveness of a combination of treatments, including two medications called durvalumab (also known by its code name MEDI4736) and tremelimumab, along with chemotherapy and a type of targeted radiation therapy called stereotactic body radiotherapy (SBRT). These treatments are followed by either surgery or additional radiation therapy to the main tumor in the lung.

The purpose of this study is to evaluate how well these combined treatments work in controlling the cancer. Participants will receive the medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will monitor the participants over a period to see how the cancer responds to the treatment and to assess the overall health and quality of life of the participants. The study aims to understand how long the cancer can be kept from progressing and to gather information on the overall survival of the participants.

Throughout the study, researchers will also look at various aspects such as the pattern of disease progression, the response to the initial therapy, and any side effects experienced before and after surgery or radiation therapy. The study will help in understanding the potential benefits and risks of using this combination of treatments for patients with this specific type of lung cancer.

1 initial treatment phase

The treatment begins with the administration of two medications: durvalumab and tremelimumab. These are given as solutions for infusion, which means they are delivered directly into the bloodstream through a vein.

The medications are administered via intravenous infusion. The specific dosage and frequency will be determined by the healthcare team based on individual patient needs and responses.

2 chemotherapy and radiotherapy

Following the initial immunotherapy, chemotherapy is administered. The specific drugs and schedule will be provided by the healthcare team.

Stereotactic body radiotherapy (SBRT) is applied to all metastases. This is a precise form of radiation therapy aimed at targeting cancer cells in specific areas.

3 surgery or additional radiotherapy

After the completion of chemotherapy and SBRT, the next step involves either surgery or additional radiotherapy to the primary tumor in the lung.

The decision between surgery and radiotherapy will depend on the patient’s specific condition and the response to previous treatments.

4 follow-up and monitoring

Regular follow-up appointments are scheduled to monitor the patient’s health and the effectiveness of the treatment.

Progression-free survival is assessed at one year, along with other factors such as overall survival, disease progression patterns, and quality of life.

Who Can Join the Study?

The patient must have a confirmed diagnosis of NSCLC. This stands for Non-Small Cell Lung Cancer.
The patient must have synchronous oligo-metastatic stage IV disease. This means the cancer has spread to a few other places in the body, with a maximum of three distant metastases, and at least one must be outside the brain for a specific treatment called SBRT (Stereotactic Body Radiation Therapy).
Initial mediastinal staging is recommended. This involves checking the area between the lungs, usually with a special procedure called endobronchial ultrasound (EBUS), unless the lymph nodes are very small and not showing signs of cancer on scans.
If the patient has one single CNS metastasis (cancer spread to the brain) or one adrenal metastasis (cancer spread to the adrenal gland), it can be surgically removed before joining the study, but one metastasis outside the brain must still be available for SBRT.
The patient must be able to understand the study and give written consent, meaning they agree to participate and follow the study procedures.
The patient must be at least 18 years old.
The patient must have an ECOG Performance Status of 0-1. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to do light work.
The patient must have available tumor tissue for research purposes related to the study.
The patient must have adequate blood, kidney, and liver function. This means their blood tests show that these organs are working well enough to participate in the study.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have more than a few small areas where the cancer has spread.
Patients who have had a different type of treatment for their cancer recently.
Patients who have other serious health problems that could affect the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend appointments.
Patients who have allergies to the medications used in the study.
Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Erwkrxu Uzvvjwpjlbkt Mtrujat Cpzsxwg Rqrrmxquj (zjqucxx Mdt	Rotterdam	The Netherlands
Hzouhgxv Dj Lm Sqqzq Cvzw I Swla Pzq	Barcelona	Spain
Hiiukxys Vcit dbhjsypm	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	03.08.2020
Spain	Not recruiting	03.08.2020
The Netherlands	Not recruiting	03.08.2020

Trial locations

Investigated drugs:

Durvalumab is a type of immunotherapy used in this trial. It helps the body’s immune system to detect and fight cancer cells more effectively. It is specifically used for patients with non-small cell lung cancer.

Tremelimumab is another immunotherapy medication included in the trial. It works by enhancing the immune system’s ability to attack cancer cells, complementing the effects of durvalumab.

Chemotherapy involves the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used alongside other treatments to help control the spread of non-small cell lung cancer.

Stereotactic Body Radiotherapy (SBRT) is a form of radiation therapy that precisely targets cancer cells in the body. It is used in this trial to treat metastases, which are cancerous growths that have spread from the primary tumor to other parts of the body.

Investigated diseases:

Non-Small Cell Lung Cancer (NSCLC), Synchronous Oligo-Metastatic – This form of lung cancer is characterized by the presence of a limited number of metastatic sites at the time of diagnosis. It primarily affects the lungs but can spread to other parts of the body, such as the bones or brain. The disease progresses as cancer cells grow and potentially spread to nearby tissues and organs. In its synchronous oligo-metastatic form, the cancer has already spread to a few distant sites at the time of initial diagnosis. The progression can vary, with some patients experiencing slow growth while others may have more rapid disease advancement. Understanding the pattern of spread and growth is crucial for determining the appropriate treatment approach.

Trial ID:

2024-511134-12-00

Protocol code:

ETOP 14-18 CHESS

NCT ID:

NCT03965468

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Durvalumab, Tremelimumab, Chemotherapy, and Radiotherapy for Patients with Newly Diagnosed Non-Small Cell Lung Cancer with Limited Spread

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?