Not recruiting

Study on the Effect of Adding Thoracic Radiotherapy to Durvalumab and Chemotherapy for Patients with Extensive Stage Small-Cell Lung Cancer

Verified siteRegistered drugNo placebo

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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 extensive stage small-cell lung cancer. The trial is investigating whether adding a type of radiation treatment to a combination of medications can help patients live longer. The medications being used in this study include durvalumab, also known by its code name MEDI4736, which is a type of immunotherapy. Immunotherapy is a treatment that helps the body's immune system fight cancer. This study also involves chemotherapy, which is a common cancer treatment that uses drugs to kill cancer cells.

The purpose of the study is to find out if combining radiation therapy with durvalumab and chemotherapy can improve the survival rate of patients with this type of lung cancer. Participants in the study will receive these treatments, and some may receive a placebo instead of the active medication. The study will monitor the participants over time to see how well the treatments work and to check for any side effects. The study aims to understand the benefits of this combined treatment approach over a period of several years.

Throughout the study, researchers will look at various outcomes, such as how long patients live after starting the treatment and how the cancer responds to the treatment. They will also assess the quality of life of the participants and any side effects they experience. This information will help determine if the addition of radiation therapy to the existing treatment plan can provide a significant benefit to patients with extensive stage small-cell lung cancer.

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
Joining the study
Upon joining the study, informed consent is required. This involves understanding and agreeing to the study's requirements and restrictions.
Eligibility is confirmed based on specific criteria, including age, health status, and lung cancer stage.
Step 2
Initial assessment
An initial assessment is conducted to evaluate lung function and overall health. This includes tests like pulmonary function tests and imaging scans such as CT or MRI.
The presence of at least one lesion in the thorax that can be treated is confirmed.
Step 3
Treatment phase
The treatment involves the administration of durvalumab, an immunotherapy drug, given intravenously. The specific dosage and frequency are determined by the study protocol.
Chemotherapy is administered alongside durvalumab. The exact drugs and schedule are specified in the study protocol.
Thoracic radiotherapy is added to the treatment regimen. This involves targeted radiation to the chest area.
Step 4
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor health status and response to treatment. This includes physical examinations and imaging tests.
The frequency and severity of any side effects are recorded and managed as necessary.
Step 5
End of treatment evaluation
At the end of the treatment phase, a comprehensive evaluation is conducted to assess the overall response to the therapy.
Long-term follow-up may continue to monitor survival rates and quality of life over several years.

Who can join the trial?

13 criteria

Must be able to give signed informed consent, which means agreeing to the study's rules and procedures.
Have **Stage IV disease** according to the TNM v8 system. Patients with **Stage III disease** can join if the disease is too widespread to be treated as limited stage small-cell lung cancer (SCLC).
Have good lung function, with **FEV1** (a measure of how much air you can forcefully exhale in one second) greater than 1 liter or more than 30% of the predicted value, and **DLCO** (a test that measures how well your lungs transfer gas) greater than 30% of the predicted value.
Female patients who can have children should use highly effective birth control and avoid pregnancy during the study and for at least 5 months after the last dose.
Patients with **brain metastases** (cancer that has spread to the brain) can join if they have no symptoms or are stable on steroids and/or anticonvulsants before starting treatment.
Must be at least 18 years old at the time of joining the study.
Have an **ECOG performance status** of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Body weight must be more than 30 kg (about 66 pounds).
Have adequate organ and bone marrow function, meaning the organs and bone marrow are working well enough.
Must be willing and able to follow the study's rules, including attending treatment sessions, scheduled visits, exams, and follow-up.
Have a life expectancy of at least 3 months.
Have at least one lesion (abnormal tissue) in the chest area that hasn't been treated with radiation before and can be treated with radiation to 30 Gy in 10 sessions. A **CT scan** or **MRI** must be done within 28 days before starting the study to assess the tumor.
Have a confirmed diagnosis of small-cell lung cancer (SCLC) through a **histological** (study of tissue) or **cytological** (study of cells) test. Mixed types of cancer may be allowed if more than 90% is SCLC.

Who cannot join the trial?

8 criteria

Patients with any other type of cancer besides small-cell lung cancer, extensive stage cannot participate. This means the study is only for those with this specific type of lung cancer.
Patients who have had previous treatment with durvalumab or similar medications are not eligible. Durvalumab is a type of medicine used to help the immune system fight cancer.
Patients with serious heart problems are excluded. This includes conditions like heart failure or recent heart attacks.
Patients with uncontrolled infections cannot join. This means if an infection is not being managed well with treatment, the patient cannot participate.
Patients with severe liver or kidney disease are not eligible. This refers to serious problems with these organs that affect their normal function.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial within the last 4 weeks are excluded. This is to ensure that previous treatments do not affect the study results.
Patients with known allergies to the study medications are not eligible. This means if a patient has had a bad reaction to similar drugs before, they cannot participate.

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Verified sites

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

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
North Estonia Medical Centre Foundation
Responsive
Tallin, Estonia
Sykehuset I Vestfold HF
Responsive
Tonsberg, Norway

Trial locations

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Investigated drugs

Durvalumab
is an immunotherapy medication used in this trial. It helps the body's immune system to detect and fight cancer cells more effectively. It is being tested to see if it can improve survival rates in patients with extensive stage small-cell lung cancer when combined with other treatments.
Chemotherapy
is a type of cancer treatment that uses drugs to destroy cancer cells. In this trial, chemotherapy is used alongside durvalumab to see if the combination can improve the survival of patients with extensive stage small-cell lung cancer.
Thoracic Radiotherapy (TRT)
is a treatment that uses high-energy rays to target and kill cancer cells in the chest area. This trial is investigating whether adding thoracic radiotherapy to the combination of durvalumab and chemotherapy can further improve the survival rates of patients with extensive stage small-cell lung cancer.

Durvalumab

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, typically given in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating extensive-stage small-cell lung cancer. The main therapeutic indication for durvalumab is to enhance the immune system's ability to fight cancer cells. At the molecular level, durvalumab works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. It is classified as an immunotherapy drug, specifically a PD-L1 inhibitor.

Investigated diseases

Small-cell lung cancer, extensive stage – This is a type of lung cancer characterized by small cells that multiply quickly and form large tumors. It is called "extensive stage" when the cancer has spread beyond the lungs to other parts of the body. The disease progresses rapidly, often involving the liver, bones, and brain. Symptoms may include coughing, chest pain, and difficulty breathing. As the cancer advances, it can lead to weight loss and fatigue. The rapid growth and spread make it a challenging condition to manage.