Study of Durvalumab, Carboplatin and Etoposide combination therapy for patients with metastatic large-cell neuroendocrine lung cancer who have not received previous treatment

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What is this study about?

This study focuses on patients with metastatic pulmonary large-cell neuroendocrine carcinoma (LCNEC), a rare type of lung cancer that has spread to other parts of the body. The treatment being tested combines three medications: durvalumab (also known as MEDI4736), carboplatin, and etoposide. The purpose of this study is to determine how effective this combination of medications is in treating patients who have not received previous treatment for their metastatic LCNEC.

During the study, patients will receive a combination of carboplatin and etoposide along with durvalumab for four treatment cycles. After these initial cycles, patients will continue receiving only durvalumab as maintenance therapy. All medications will be given through intravenous (into the vein) infusions. Durvalumab is a type of medication called a monoclonal antibody that helps the immune system fight cancer cells, while carboplatin and etoposide are traditional chemotherapy medications that work by directly attacking cancer cells.

The study will measure how well patients respond to the treatment by tracking their survival time and checking if their cancer shrinks or stops growing. Doctors will monitor patients throughout the study to check for any side effects from the treatment. Regular medical examinations and imaging tests will be performed to evaluate how the treatment is working.

1 Initial treatment phase

You will receive a combination of three medications through intravenous infusion: durvalumab (Imfinzi), carboplatin, and etoposide

This treatment phase consists of 4 cycles

Each cycle includes all three medications administered through a vein

2 Maintenance phase

After completing the initial 4 cycles, you will continue receiving only durvalumab as maintenance therapy

The maintenance treatment will be administered through intravenous infusion

3 Monitoring during treatment

Regular assessments will track your response to treatment using CT scans or MRI to measure tumor size

Your doctor will monitor any side effects throughout the treatment period

Blood tests will be performed to check your blood count, liver, and kidney function

4 Follow-up assessments

Regular check-ups will continue to monitor your health status

Imaging tests will be performed to evaluate how the treatment is working

Your doctor will assess your overall response to the treatment using standard measurement criteria

5 Safety monitoring

Any side effects will be recorded and graded according to standardized criteria

Your doctor will monitor your health status throughout the entire study period

The study will track your progress until June 2026

Who Can Join the Study?

Must be at least 18 years old
Must weigh more than 30 kg
Must be able to provide signed informed consent
Must have a life expectancy of at least 12 weeks
Must have at least one measurable tumor that is at least 10mm in size (or 15mm for lymph nodes) that can be seen on CT or MRI scans
Must have adequate blood cell counts:
– Normal white blood cell count (neutrophils ≥1500/μL)
– Adequate hemoglobin levels (≥9 g/dL)
– Adequate platelet count (≥100,000/μL)
Must have normal liver and kidney function tests
Must have normal blood clotting function
For women who can become pregnant:
– Must have a negative pregnancy test
– Must not be breastfeeding
– Must use effective birth control during treatment and for 6 months after
For men:
– Must use barrier contraception during treatment and for 6 months after
– Must not donate sperm during this period
Must have confirmed pulmonary large-cell neuroendocrine carcinoma through tissue or cell testing
Must have advanced disease (Stage IV or inoperable Stage IIIB)
Must not have had previous chemotherapy or cancer treatment, unless it was for early-stage disease at least 6 months ago
Must not need radiation therapy to the chest
Must have good physical function (ECOG performance status 0-1, meaning able to perform daily activities with minimal assistance)

Who Cannot Join the Study?

Previous treatment with any cancer therapy for metastatic large-cell neuroendocrine carcinoma (LCNEC)
Active or untreated brain metastases (spread of cancer to the brain)
History of other cancers within the past 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
Severe heart conditions, including heart failure, uncontrolled high blood pressure, or recent heart attack
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
Autoimmune conditions requiring systemic treatment (conditions where the immune system attacks healthy cells)
Severe lung disease or breathing problems
Pregnancy or breastfeeding
Unable to give informed consent
Allergic reactions to study medications or their components
Participation in another clinical trial within 30 days before starting this study
Psychiatric conditions or substance abuse that could interfere with study compliance
Serious infections requiring antibiotics within 14 days before starting treatment

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
San Camillo Forlanini Hospital	Rome	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Arfdgek Opakwafxpcp Umkesruqjpkwr Pieki	Parma	Italy
Inghdvsa Ozdxgcpgin Dsc Mzdbzmqgdhac Skdleq	Viagrande	Italy
Apjwkra Upc Tkbderz nzzo oxrio	Leghorn	Italy
Ikwcccbf Rfztxlzcb Pxo Lm Sflxci Daz Tdakey Dedb Acbzqjg Iiaw Smipfr	Meldola	Italy
Apvbmkd Urhdz Spjjddogz Lkfgco Dc Bbxbavq	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.12.2021

Trial locations

Investigated drugs:

Durvalumab (also known as MEDI 4736) is an immunotherapy medication that helps the body’s 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 tumor.

Carboplatin is a chemotherapy medication that belongs to the platinum-based drug family. It works by interfering with cancer cell DNA, preventing cancer cells from growing and dividing.

Etoposide is a chemotherapy medication that works by blocking an enzyme that cancer cells need to divide and grow. It is often used in combination with other cancer treatments to increase their effectiveness.

These medications are used together as a combination therapy, with carboplatin and etoposide given along with durvalumab for initial treatment, followed by durvalumab alone as maintenance therapy.

Investigated diseases:

Neuroendocrine carcinoma metastatic

Large-cell neuroendocrine carcinoma (LCNEC) of the lung – A rare and aggressive type of lung cancer that belongs to the group of neuroendocrine tumors. The disease develops from specialized neuroendocrine cells in the lungs that can produce hormones. LCNEC typically grows rapidly and can spread to other parts of the body, particularly when discovered at a later stage. The cancer cells appear large when viewed under a microscope and have certain features that distinguish them from other types of lung cancer. This condition shows characteristics of both non-small cell lung cancer and small cell lung cancer.

Trial ID:

2024-516157-41-00

Protocol code:

GOIRC-05-2020

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Durvalumab, Carboplatin and Etoposide combination therapy for patients with metastatic large-cell neuroendocrine lung cancer who have not received previous treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?