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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

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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

15 criteria

  • 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 trial?

13 criteria

  • 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
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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.

What is already known about the treatment

  • Durvalumab

    A monoclonal antibody medication administered through intravenous infusion that works by blocking PD-L1 protein, helping the immune system fight cancer cells. It is currently approved for treating various types of cancers and is being studied in clinical trials for metastatic pulmonary large-cell neuroendocrine carcinoma (LCNEC). This immunotherapy belongs to the class of immune checkpoint inhibitors and works by preventing cancer cells from evading the body's immune response.

  • Carboplatin

    A platinum-based chemotherapy drug given through intravenous infusion that works by interfering with DNA replication in cancer cells, preventing them from dividing and growing. It belongs to the alkylating agents class of chemotherapy medications and is commonly used in combination therapy for various types of cancer, including lung cancers. This medication is well-established in cancer treatment protocols and has a documented history of clinical effectiveness.

  • Etoposide

    An intravenous chemotherapy medication that belongs to the topoisomerase inhibitor class, working by blocking an enzyme necessary for cancer cell DNA repair and replication. It is commonly used in combination with other chemotherapy drugs, particularly in the treatment of lung cancers, and has been a standard component of chemotherapy protocols for several decades. The medication interferes with the cancer cell division process, leading to cell death.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516157-41-00Protocol codeGOIRC-05-2020Estimated enrolment49 patientsSponsorGOIRC Gruppo Oncologico Italiano Di Ricerca Clinica

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