RecruitingRare disease

Study on Durvalumab, Etoposide, and Platinum Drug Combination for First-Line Treatment of Advanced Large-Cell Neuroendocrine Lung Cancer Patients

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 clinical trial is focused on studying a type of lung cancer known as Large-Cell Neuroendocrine Carcinoma (LCNEC). This cancer can be in an advanced stage, either locally advanced or metastatic, meaning it has spread to other parts of the body. The study is investigating the effectiveness and safety of a treatment combination that includes the drug Durvalumab (also known by its code name MEDI 4736), along with two chemotherapy drugs, Etoposide and a type of platinum-based drug, which can be either Cisplatin or Carboplatin. These medications are given as an infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of this study is to determine how well this combination of drugs works as a first-line treatment, which means it is the first treatment given for this type of cancer. Participants in the study will receive these medications over a period of time, and their health will be monitored to see how the cancer responds to the treatment. The study aims to find out if this combination can help control the cancer and improve the quality of life for patients with LCNEC.

Throughout the study, participants will receive regular check-ups and assessments to track their progress and any side effects they might experience. The study will also look at how long the treatment can keep the cancer from getting worse. This information will help doctors understand if this treatment combination is a good option for patients with advanced LCNEC.

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
The treatment begins with the administration of durvalumab, carboplatin or cisplatin, and etoposide. These medications are given through a vein, a method known as intravenous infusion.
The dosage and frequency of these medications are determined by the healthcare provider based on individual patient needs and medical guidelines.
Step 2
Monitoring and assessment
Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects. This includes scheduled visits and examinations.
The primary goal is to evaluate the progression-free rate at 12 months, which means checking if the cancer has not worsened during this period.
Step 3
Continuation of treatment
The treatment continues as long as it is effective and the patient tolerates it well. Adjustments to the treatment plan may be made based on the patient's response and any side effects experienced.
Step 4
End of treatment
The treatment phase concludes when the healthcare provider determines that the treatment is no longer effective or if the patient experiences significant side effects.
Follow-up care and monitoring may continue after the treatment ends to ensure the patient's well-being and to manage any long-term effects of the treatment.

Who can join the trial?

14 criteria

Must be at least 18 years old at the time of joining the study.
For women, must be post-menopausal or have a negative pregnancy test if pre-menopausal. Post-menopausal means not having a period for 12 months without another medical reason.
Must use a highly effective form of birth control during the study and for a certain time after the last treatment. This applies to both men and women.
Must be willing and able to follow the study rules, including attending treatment sessions and check-ups.
Must be part of a social security system.
Must be able to give written consent to participate in the study, understanding all the requirements and restrictions.
Must have a confirmed diagnosis of **Large-Cell NeuroEndocrine Carcinoma of the lung (LCNEC)**.
Must have enough tumor material available for confirmation and analysis.
The disease must be either locally advanced (Stage III) and not suitable for local treatment, or metastatic (Stage IV) and in the first line of treatment.
Must have measurable disease according to specific medical guidelines (RECIST 1.1).
Must have a **Performance Status (PS)** of 0 or 1, which means being fully active or having some symptoms but still able to do light work.
Must weigh more than 30 kg (about 66 pounds).
Must have a life expectancy of at least 12 weeks.
Must have normal organ and bone marrow function, which includes specific levels of hemoglobin, neutrophils, platelets, bilirubin, and liver enzymes. If receiving cisplatin treatment, kidney function must be adequate.

Who cannot join the trial?

10 criteria

Patients who have received previous treatment for their lung cancer.
Patients with other types of cancer that are not under control or have not been treated successfully.
Patients with serious heart problems, such as heart failure or a recent heart attack.
Patients with active infections that require treatment with antibiotics or other medications.
Patients with autoimmune diseases, which are conditions where the immune system attacks the body's own cells.
Patients who are pregnant or breastfeeding.
Patients who have had an organ transplant.
Patients with known allergies to the study drugs or similar medications.
Patients with a history of drug or alcohol abuse that could interfere with the study.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
CHU Grenoble Alpes
Verified
La Tronche, France
Centre Francois Baclesse
Verified
Caen, France

Trial locations

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Investigated drugs

Durvalumab
is a medication used to help the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the body to better target and destroy them.
Etoposide
is a chemotherapy drug that helps stop the growth of cancer cells. It works by interfering with the DNA of the cancer cells, preventing them from dividing and growing.
Cisplatin
is a type of chemotherapy that contains platinum. It works by damaging the DNA in cancer cells, which stops them from multiplying and can lead to their death.
Carboplatin
is another chemotherapy drug that also contains platinum. Similar to cisplatin, it damages the DNA of cancer cells, preventing them from growing and spreading. It is often used as an alternative to cisplatin.

What is already known about the treatment

Durvalumab
Durvalumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating large-cell neuroendocrine carcinoma of the lung. It is primarily used in combination with other chemotherapy agents like etoposide and platinum-based drugs. The medication works by blocking a protein called PD-L1, which helps the immune system recognize and attack cancer cells. Durvalumab is classified as an immune checkpoint inhibitor.
Etoposide
Etoposide is given intravenously and is a well-established chemotherapy drug used in the treatment of various cancers, including large-cell neuroendocrine carcinoma of the lung. It works by inhibiting an enzyme called topoisomerase II, which is necessary for DNA replication, thereby preventing cancer cell division. Etoposide is classified as a topoisomerase inhibitor.
Cisplatin
Cisplatin is administered intravenously and is a widely used chemotherapy drug for treating different types of cancer, including large-cell neuroendocrine carcinoma of the lung. It works by forming cross-links in DNA, which disrupts DNA synthesis and function, leading to cancer cell death. Cisplatin is classified as a platinum-based chemotherapy agent.
Carboplatin
Carboplatin is given intravenously and is used in the treatment of various cancers, including large-cell neuroendocrine carcinoma of the lung. It functions similarly to cisplatin by forming DNA cross-links that inhibit DNA replication and transcription, resulting in cancer cell death. Carboplatin is also classified as a platinum-based chemotherapy agent.

Investigated diseases

Large-Cell Neuroendocrine Carcinoma of the Lung – This is a rare type of lung cancer characterized by large cells that have features of both neuroendocrine and carcinoma cells. It typically begins in the lungs and can grow rapidly, often spreading to other parts of the body. The disease is known for its aggressive nature and can be challenging to diagnose due to its similarities with other types of lung cancer. Symptoms may include cough, chest pain, and difficulty breathing, which can worsen as the disease progresses. It is often diagnosed at an advanced stage, making early detection difficult. The progression of the disease can vary, but it generally involves rapid growth and spread to other organs.