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Durvalumab Maintenance Therapy for Frail Patients with Limited Stage Small Cell Lung Cancer After Chemoradiotherapy

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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 Small Cell Lung Cancer (SCLC), specifically in patients whose disease is limited to the chest area. The study is investigating the use of a treatment called durvalumab, also known by its code name MEDI4736. Durvalumab is a type of immunotherapy, which is a treatment that helps the body's immune system fight cancer. The trial is designed for patients who are considered frail, meaning they may have other health conditions or are older, making them less able to tolerate aggressive treatments.

The purpose of the study is to evaluate how effective durvalumab is in maintaining the health of patients after they have received a combination of chemotherapy and radiation therapy, known as thoracic chemoradiotherapy (CRT). The study will compare the outcomes of patients who receive durvalumab with those who are under regular observation without the drug. Patients will receive durvalumab through an intravenous infusion, which means the medication is given directly into a vein. The treatment period can last up to 24 months, depending on how well the patient responds to the therapy.

Throughout the study, patients will have regular check-ups and assessments to monitor their health and the progression of their cancer. These assessments may include imaging tests like MRI or CT scans to evaluate the size and spread of the cancer. The study aims to determine if durvalumab can help extend the time patients live without their cancer getting worse, which is referred to as progression-free survival. Additionally, the study will look at the overall survival of patients and any side effects they may experience from the treatment.

The research process

The trial runs in 6 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, the patient must have a confirmed diagnosis of frail limited disease small cell lung cancer. This includes a complete radiological evaluation within 28 days before starting chemotherapy.
The patient must sign a written informed consent form before any trial-specific procedures begin.
Step 2
Initial treatment
The patient undergoes thoracic chemoradiotherapy (CRT), which may be given either concurrently or sequentially. The CRT involves receiving at least 60 Gy of radiation or 45 Gy twice daily, combined with a chemotherapy regimen of cisplatin-etoposide or carboplatin-etoposide.
Step 3
Randomization
After completing CRT, the patient is assessed for disease control using imaging techniques such as CT or PET scans.
The patient must sign a second informed consent form before randomization and any specific trial procedures.
Step 4
Maintenance treatment
The patient receives maintenance treatment with durvalumab, an immunotherapy drug. This is administered as an intravenous infusion.
The treatment aims to evaluate the progression-free survival of the patient.
Step 5
Follow-up and assessments
Throughout the trial, the patient's health and response to treatment are monitored through scheduled visits and examinations.
Quality of life is assessed using specific questionnaires designed for lung cancer patients.
Step 6
End of trial
The trial is estimated to conclude by June 30, 2028. The primary endpoint is the time from randomization until disease progression or death from any cause.

Who can join the trial?

23 criteria

Patient must have signed a first written informed consent form before any trial-specific procedures.
Patient must be willing and able to follow the trial protocol, including treatment, visits, and examinations.
Women who can have children must have a negative pregnancy test before starting the trial and use effective birth control during the trial and for 3 months after.
Patient must have a limited disease according to specific medical classifications, confirmed by certain scans like PET, CT, or MRI.
All sexually active men and women who can have children must use effective birth control during the trial and for 3 months after.
Patient must be part of the social security system.
Patient must have a confirmed diagnosis of Small Cell Lung Cancer (SCLC).
Patient must have a measurable disease according to specific medical criteria.
Patient must not have been previously treated for SCLC, but those who have started initial treatment are eligible.
Patient must be 18 years or older.
Patient must have signed a second written informed consent form before randomization.
Patient must belong to specific groups based on health status and age after initial treatment.
Patient must have completed a specific type of radiation therapy with certain medications.
Patient must show disease control through specific scans after initial treatment.
Use of brain MRI is required if certain preventive treatments are avoided.
Patient must complete a quality of life questionnaire.
Patient must have adequate blood health, including specific levels of hemoglobin, platelets, and neutrophils.
Patient must have adequate kidney function, measured by a specific formula.
Patient must have adequate liver function, with specific levels of bilirubin and liver enzymes.
Any unresolved side effects from previous cancer treatments must be mild, except for hair loss and skin changes.
Patient must weigh more than 30 kg.
Patient can be a candidate for specific radiation therapy if they meet certain conditions.
Patients who had previous chest radiation may be eligible if they can follow the planned treatment schedule.

Who cannot join the trial?

4 criteria

Patients who have already received treatment for their **Limited Disease Small Cell Lung Cancer** cannot participate. This means if you have already been treated for this type of lung cancer, you are not eligible.
Patients who are not considered **frail** are excluded. Frail generally refers to being physically weak or having reduced strength, often due to age or illness.
Patients who have received **concomitant thoracic CRT** are excluded. This means if you have had a type of radiation therapy to the chest area at the same time as other treatments, you cannot join the study.
Patients with certain **comorbidities** are excluded. Comorbidities are other health conditions or diseases you might have alongside your lung cancer.

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Verified sites

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

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Assistance Publique Hopitaux De Marseille
Marseille, France
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Centr Georges Francois Leclerc
Dijon, France
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Centre Francois Baclesse
Caen, France

Trial locations

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Investigated drugs

Durvalumab (MEDI 4736) is a medication used in this clinical trial. It is an immunotherapy drug that helps the body's immune system to fight cancer cells. In this study, it is given to patients with a specific type of lung cancer called limited disease small cell lung cancer. The goal is to see if durvalumab can help prevent the cancer from coming back or getting worse after the patients have already received a combination of chemotherapy and radiation therapy.

Durvalumab

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, typically given in a healthcare setting. It is currently being studied in clinical trials for its effectiveness in treating certain types of lung cancer, specifically frail patients with limited disease small cell lung cancer who have not received prior treatment. The main therapeutic indication for durvalumab is to maintain disease control after initial treatment with chemoradiotherapy. At the molecular level, durvalumab works by blocking a protein called PD-L1, which helps cancer cells evade the immune system, thereby allowing the body's immune system to better attack the cancer. It is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Small Cell Lung Cancer – Small Cell Lung Cancer (SCLC) is a fast-growing type of lung cancer that primarily affects smokers. It is characterized by small cells that multiply quickly and form large tumors. Limited Disease Small Cell Lung Cancer (LD-SCLC) refers to cancer that is confined to one side of the chest and can be treated with radiation therapy. The disease progresses rapidly, often spreading to other parts of the body if not treated promptly. Symptoms may include coughing, chest pain, and difficulty breathing. It is often diagnosed at an advanced stage due to its aggressive nature.