Study of Durvalumab, Cisplatin, Carboplatin, and Etoposide for Patients with Extensive Stage Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as extensive stage small cell lung cancer (SCLC). The trial will explore a treatment plan that combines several therapies to see if it can improve patient outcomes. The treatment involves using a combination of medications and therapies, including Durvalumab (also known by its code name MEDI4736), Cisplatin, Carboplatin, and Etoposide. These medications are given as solutions through an infusion, which means they are delivered directly into the bloodstream.

The purpose of the study is to test the feasibility and effectiveness of this treatment plan. The treatment will start with a combination of chemotherapy and radiotherapy, which is a type of cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors. This will be followed by a more targeted form of radiotherapy called stereotactic radiotherapy, which aims to precisely target cancer cells while sparing healthy tissue. The study will also look at how well this treatment plan can help patients live longer without the cancer getting worse over a period of 12 months.

Participants in the study will receive the treatment over a period of time, with the initial phase involving chemotherapy and radiotherapy, followed by maintenance therapy with Durvalumab. The study aims to gather information on how well patients respond to this combination of treatments and whether it can improve their quality of life and survival rates. The trial is expected to continue until 2026, with recruitment starting in 2024.

1 initial treatment phase

Upon joining the clinical trial, you will begin the initial treatment phase. This involves receiving a combination of medications through an intravenous infusion. The medications include cisplatin, carboplatin, durvalumab, and etoposide.

These medications are administered to you in a hospital or clinical setting. The dosage and frequency of these medications will be determined by the medical team based on your specific condition and response to treatment.

2 concurrent radiotherapy

During this phase, you will receive thoracic radiotherapy. This is a type of radiation treatment aimed at the chest area, which is given alongside the medication therapy.

The goal of this phase is to target the cancer cells in the chest while continuing the medication treatment to enhance its effectiveness.

3 stereotactic radiotherapy

Following the initial treatment and concurrent radiotherapy, you will undergo stereotactic radiotherapy. This is a precise form of radiation therapy that targets specific tumor sites with high accuracy.

This phase is designed to treat any remaining tumor lesions or metastases that can be addressed with this focused radiation approach.

4 maintenance therapy

After completing the stereotactic radiotherapy, you will enter the maintenance therapy phase. During this time, you will continue to receive durvalumab to help maintain the treatment’s effectiveness.

The frequency and duration of this maintenance therapy will be determined by your healthcare team, based on your progress and overall health status.

5 follow-up and monitoring

Throughout the clinical trial, regular follow-up appointments will be scheduled to monitor your health and the effectiveness of the treatment.

These appointments may include physical examinations, imaging tests, and other assessments to ensure the treatment is working as intended and to manage any side effects.

Who Can Join the Study?

Must have a first diagnosis of extensive stage small cell lung cancer (ES-SCLC), confirmed by a tissue sample test.
Must have oligometastatic disease, which means having a primary tumor with or without certain lymph node metastases, and up to four distant tumor lesions that can be treated with a specific type of radiation therapy. Must not have a confirmed cancerous fluid buildup in the chest area.
Must have a stable disease (SD) or a partial response (PR) after previous treatment with two cycles of specific chemotherapy drugs (platinum/etoposide/durvalumab), according to specific medical criteria (RECIST 1.1).
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.
Must have a life expectancy of at least 12 weeks.
Must be an adult, as the study includes both male and female participants.

Who Cannot Join the Study?

Patients with any other type of cancer besides extensive stage small cell lung cancer (SCLC) cannot participate.
Patients who have had previous treatments that might interfere with the study treatment are not eligible.
Patients with serious health conditions that could make the study treatment unsafe for them cannot join.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients who are unable to follow the study procedures or attend the required visits are not eligible.
Patients with known allergies to the study drugs or similar medications cannot participate.
Patients who are currently participating in another clinical trial are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Rostock University Medical Center	Rostock	Germany

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Kliniken Maria Hilf GmbH Moenchengladbach	Moenchengladbach	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Saarland University Hospital	Homburg	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Uvyayeluulqivfkngbvao Aphueryq	Augsburg	Germany
Ugrevudayntalotvyzwlx Wxkjnlcgn Aoy	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	30.10.2024

Trial locations

Investigated drugs:

Durvalumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, Durvalumab is used in combination with other treatments to help improve the outcomes for patients with extensive stage small cell lung cancer (SCLC). It is given alongside other therapies to enhance their effectiveness and is also used as a maintenance treatment to help keep the cancer from coming back.

Platinum refers to a group of chemotherapy drugs that contain the metal platinum. These drugs work by damaging the DNA of cancer cells, which prevents them from dividing and growing. In this trial, a platinum-based drug is used in combination with other treatments to help shrink the cancer and stop it from spreading.

Etoposide is a chemotherapy medication that helps stop cancer cells from dividing and growing. It works by interfering with the DNA of the cancer cells. In this trial, Etoposide is used together with other treatments to help control the cancer and improve patient outcomes.

Investigated diseases:

Extensive stage small cell lung cancer (SCLC) – This is a type of lung cancer characterized by the rapid growth and spread of small cells in the lung tissue. It is known for its aggressive nature and tendency to metastasize quickly to other parts of the body, such as the liver, brain, and bones. The disease typically begins in the central airways of the lungs and can cause symptoms like coughing, chest pain, and difficulty breathing. As it progresses, it may lead to more severe respiratory issues and systemic symptoms like weight loss and fatigue. The extensive stage indicates that the cancer has spread beyond the lung to other regions, making it more challenging to manage.

Trial ID:

2024-517937-41-00

Protocol code:

DuCoRa-SCLC

NCT ID:

NCT06223711

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Durvalumab, Cisplatin, Carboplatin, and Etoposide for Patients with Extensive Stage Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?