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Study of Durvalumab with Thoracic Radiotherapy and Chemotherapy for Patients with Extensive Stage Small Cell Lung Cancer After Initial Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with extensive-stage small cell lung cancer who have responded to initial treatment. The research examines the effectiveness of combining chest radiation therapy with a medication called durvalumab (also known as MEDI4736). This medication belongs to a group of drugs called immunotherapy, which helps the body's immune system fight cancer cells.

The study evaluates how well patients respond to treatment that includes chemotherapy drugs (cisplatin or carboplatin, and etoposide) given together with durvalumab, followed by durvalumab alone while receiving radiation therapy to the chest area. The main goal is to determine how long patients can live without their cancer getting worse after receiving this combination of treatments.

During the study, participants will receive durvalumab through intravenous infusion, which means the medication is given directly into a vein. The maximum daily dose of durvalumab is 1500 milligrams, and treatment may continue for up to 15 months. Throughout the study, doctors will monitor the cancer's response to treatment and check for any side effects.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive first-line treatment consisting of chemotherapy (cisplatin or carboplatin with etoposide) combined with durvalumab through intravenous infusion for up to 4 cycles
Your response to this treatment will be evaluated through imaging tests to confirm if the disease is stable or showing improvement
Step 2
Maintenance therapy
After completing the initial treatment phase, you will continue receiving durvalumab alone as maintenance therapy through intravenous infusion
During this phase, you will also receive thoracic radiation therapy targeting the chest area
Step 3
Monitoring and evaluation
Regular medical assessments will track your progress for at least 12 months
These assessments will include imaging tests to check for any signs of disease progression in the chest area or other parts of the body
Your doctor will monitor for any side effects and evaluate your overall health status
Quality of life assessments will be conducted throughout the study period
Step 4
Long-term follow-up
The study will continue monitoring your health status until January 2028
Regular check-ups will assess your overall survival and any late effects of the treatment
Imaging tests will continue to evaluate the control of cancer in the chest area and check for any spread of disease

Who can join the trial?

15 criteria

Age between 18 and 80 years
Confirmed large-stage small cell lung cancer through tissue examination (histology)
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Have completed up to 4 cycles of platinum-based chemotherapy plus Durvalumab with either:
- Complete response (cancer has disappeared)
- Partial response (cancer has shrunk)
- Stable disease (cancer has not grown)
- check
  Must have had imaging tests including:
  - Chest and abdomen CT scan
  - Bone scan or PET-CT scan
  - Brain MRI
  - Good physical condition (ECOG Performance Status between 0-2, meaning able to care for self and be up and about more than 50% of waking hours)
  - Normal lung function
  - Treatment area (planning target volume) less than 600 cc
  - Body weight more than 30 kg
  - No previous radiation therapy to the chest area
  - Able to understand and sign informed consent
  - If able to have children (both men and women), must use effective birth control during the study

Who cannot join the trial?

14 criteria

History of other cancers within the past 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
Active or prior autoimmune disease (a condition where the immune system attacks healthy cells in the body)
Current use of immunosuppressive medication (drugs that lower the activity of the immune system)
Active or untreated brain metastases (cancer spread to the brain)
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Uncontrolled heart conditions including:
- Heart failure
- Uncontrolled high blood pressure
- Unstable heart rhythm disorders
- Active infections requiring systemic treatment
- Known allergy or sensitivity to study medications
- Pregnant or breastfeeding women
- Previous treatment with immune checkpoint inhibitors
- Significant liver problems or abnormal liver function tests
- Active tuberculosis or hepatitis B or C infection
- Any condition that, in the opinion of the study doctor, would interfere with safe participation in the study

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Verified sites

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

Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Azienda Ospedaliero Universitaria Parma
Parma, Italy
Responsive
Istituto Oncologico Veneto
Padua, Italy

Trial locations

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Investigated drugs

Cisplatin is a chemotherapy medication used to treat various types of cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. Carboplatin is a chemotherapy medication similar to cisplatin but often with fewer side effects. It is commonly used in the treatment of various cancers and works by interfering with cancer cell DNA. Etoposide is a chemotherapy medication that stops cancer cells from growing and dividing. It works by blocking an enzyme that cancer cells need to survive. Durvalumab is an immunotherapy medication that helps the immune system fight cancer cells. It works by blocking a protein that cancer cells use to hide from the immune system, allowing the body's natural defenses to better recognize and attack the cancer. Thoracic Radiation Therapy is a treatment that uses high-energy X-rays targeted at the chest area to destroy cancer cells. This is not a medication but rather a form of radiation treatment delivered to the thorax (chest) area.

Durvalumab

What is already known about the treatment

Durvalumab
A monoclonal antibody medication administered through intravenous infusion, used in immunotherapy for extensive-stage small cell lung cancer (SCLC). It works by blocking the PD-L1 protein on cancer cells, enabling the immune system to better recognize and attack tumor cells. This medication is currently approved for maintenance therapy following platinum-based chemotherapy in SCLC patients, showing promising results in clinical trials when combined with standard chemotherapy agents like cisplatin/carboplatin and etoposide.
Cisplatin
A platinum-based chemotherapy drug administered intravenously, widely used in the treatment of various cancers including small cell lung cancer. It works by interfering with DNA replication in cancer cells, preventing them from dividing and ultimately leading to cell death. This medication belongs to the alkylating agents class and is often used as a first-line treatment in combination with other chemotherapy drugs.
Carboplatin
A second-generation platinum chemotherapy medication given through intravenous infusion, commonly used as an alternative to cisplatin in treating small cell lung cancer. It causes less severe side effects compared to cisplatin while maintaining similar efficacy, making it particularly suitable for patients who cannot tolerate cisplatin. Like cisplatin, it works by binding to and damaging DNA in cancer cells.
Etoposide
A chemotherapy medication administered intravenously, belonging to the topoisomerase inhibitor class of drugs. It works by blocking an enzyme called topoisomerase II, which is essential for cancer cell division, thereby preventing tumor growth. This medication is commonly used in combination with platinum-based drugs for the treatment of small cell lung cancer and has been a standard component of SCLC treatment regimens.

Investigated diseases

Small Cell Lung Cancer
A fast-growing type of lung cancer that develops in the lung tissue and spreads quickly to other parts of the body. It typically starts in the bronchi, which are the large airways that lead to the lungs. The disease is characterized by small, round cancer cells that multiply rapidly and form large tumors. Small cell lung cancer often spreads (metastasizes) to other organs before it is discovered. This type of cancer is distinguished from other lung cancers by the size and appearance of the cancerous cells under a microscope, as well as by its aggressive growth pattern.
Extended Stage Small Cell Lung Cancer
An advanced form of small cell lung cancer where the cancer has spread beyond one lung and nearby lymph nodes to other parts of the body. In this stage, cancer cells have traveled through the bloodstream or lymphatic system to create tumors in other organs. The disease affects multiple areas of the body simultaneously, commonly spreading to the brain, liver, adrenal glands, or bones. This stage represents the more extensive form of the disease where cancer has progressed beyond localized areas.