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 study about?

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.

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

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

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

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 Study?

Age between 18 and 80 years
Confirmed large-stage small cell lung cancer through tissue examination (histology)
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)
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 Study?

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)
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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda Provinciale Per I Servizi Sanitari	Trento	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
IRCCS Ospedale Sacro Cuore Don Calabria	Negrar di Valpolicella	Italy
Awujusl Ongadxdkdvu Uwvxfhvyujugg Pprnf	Parma	Italy
Aatiapp Usa Igqxm Da Rswwlp Efmpeu	Reggio Emilia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.01.2025

Trial locations

Investigated drugs:

Durvalumab

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.

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.

Trial ID:

2024-517445-13-00

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?