Not recruitingRare disease

Study on Atezolizumab, Carboplatin, and Etoposide for Adults with Advanced Large-Cell Neuroendocrine Lung Cancer

Fast replyRegistered 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. This is a serious condition where cancer cells form in the tissues of the lung. The study is testing a combination of treatments to see how effective they are in treating this cancer. The treatments being used in this study include Atezolizumab, which is a medication that helps the immune system fight cancer, and a group of chemotherapy drugs known as Platinum drugs, specifically Carboplatin and Cisplatin, along with Etoposide. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how well these treatments work together in improving the survival of patients with this type of lung cancer. Participants in the study will receive these treatments over a period of time, and their health will be monitored to see how the cancer responds. The study will also look at how long patients live after starting the treatment and how the cancer changes during the study.

Throughout the study, researchers will collect information on how the cancer responds to the treatment, including any changes in the size of the cancer and how long it takes for the cancer to start growing again. The study will also monitor any side effects that participants may experience from the treatment. This information will help doctors understand more about the effectiveness and safety of using Atezolizumab with Platinum drugs and Etoposide for treating large-cell neuroendocrine carcinoma of the lung.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will provide written informed consent. This means you agree to participate after understanding the trial's purpose and procedures.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes checking your medical history and current health status to ensure you meet the trial's criteria.
Step 3
Treatment plan
The treatment involves a combination of medications administered through intravenous infusion. This means the drugs are given directly into your vein.
The medications include etoposide, carboplatin or cisplatin, and atezolizumab (Tecentriq).
Step 4
Treatment cycles
The treatment is given in cycles. Each cycle lasts for a specific period, followed by a rest period to allow your body to recover.
The exact dosage and frequency of each medication will be determined by the medical team based on your individual needs.
Step 5
Monitoring and follow-up
Throughout the trial, regular monitoring will occur to assess your response to the treatment and manage any side effects.
This includes physical exams, blood tests, and imaging studies to track the progress of the treatment.
Step 6
End of trial
The trial is expected to continue until January 31, 2029. Your participation may end earlier if the treatment is not effective or if you experience significant side effects.
At the end of your participation, a final assessment will be conducted to evaluate your overall health and the outcomes of the treatment.

Who can join the trial?

12 criteria

Provide written informed consent, which means you agree to participate after understanding the study details.
Have a diagnosis of locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung (LCNEC) without options for curative treatment. If your cancer has mixed types, LCNEC should be the main type (at least 50%).
Have not received previous systemic therapy (treatment that affects the entire body). If you had curative treatment like chemotherapy or radiation and the cancer returned at least 6 months after stopping treatment, you can still participate.
Plan to receive treatment with Carboplatin or Cisplatin and Etoposide, which are standard chemotherapy drugs.
Have an ECOG performance status of 0 to 2, which is a scale that measures your ability to perform daily activities. A score of 0 means fully active, while 2 means you are up and about more than half the day.
Be at least 18 years old.
Have measurable disease according to RECIST v1.1, which means the cancer can be measured using specific criteria.
Have adequate organ function, which includes:
- Alanine Aminotransferase (ALAT) / Aspartate Aminotransferase (ASAT) levels no more than 2.5 times the upper limit of normal (ULN), or 3.5 times if you have liver metastases.
- Bilirubin levels no more than 1.5 times ULN, or 2.5 times if you have liver metastases.
- Creatinine levels no more than 1.5 times ULN, or a creatinine clearance greater than 60 ml/min according to the Cockroft-Gault formula.
- Neutrophil count of at least 1 Gigaparticle (Gpt)/l.
- Platelet count greater than 50 Gpt/l, unless low levels are due to cancer in the bone marrow.

Who cannot join the trial?

10 criteria

Patients who have received any other cancer treatment within the last 4 weeks.
Patients with a history of severe allergic reactions to the study drugs.
Patients with active infections that require treatment.
Patients with other serious medical conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 4 weeks.
Patients with a history of another type of cancer, unless it has been in remission for at least 5 years.
Patients with brain metastases, which means the cancer has spread to the brain, unless they have been treated and are stable.
Patients with autoimmune diseases, which are conditions where the immune system attacks the body, unless they are in a stable condition.
Patients with a history of drug or alcohol abuse within the last 12 months.

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Verified sites

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

Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Verified
Mainz, Germany
Deutsches Herzzentrum Berlin
Verified
Berlin, Germany
Thoraxklinik Heidelberg gGmbH
Responsive
Heidelberg, Germany

Trial locations

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Investigated drugs

Atezolizumab
is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, Atezolizumab is being tested to see if it can improve the survival of patients with a specific type of lung cancer called large-cell neuroendocrine cancer when used alongside standard chemotherapy treatments.
Platinum
refers to a group of chemotherapy drugs that contain the metal platinum. These drugs work by damaging the DNA of cancer cells, which stops them from growing and dividing. In this trial, a platinum-based drug is used as part of the standard chemotherapy treatment to help fight the cancer.
Etoposide
is a chemotherapy medication that helps stop cancer cells from dividing and growing. It does this by interfering with the DNA inside the cancer cells. In this trial, Etoposide is used as part of the standard chemotherapy treatment to help treat the lung cancer.

What is already known about the treatment

Atezolizumab – Atezolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently being studied in clinical trials for its effectiveness in treating advanced large-cell neuroendocrine carcinoma of the lung, a type of lung cancer that cannot be cured with surgery. The main purpose of using Atezolizumab in this context is to improve the survival of patients when combined with standard chemotherapy. At the molecular level, Atezolizumab works by blocking a protein that helps cancer cells hide from the immune system, allowing the body's natural defenses to better attack the cancer. It is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system recognize and fight cancer cells.

Investigated diseases

Large-cell neuroendocrine carcinoma of the lung – This is a type of lung cancer characterized by large, abnormal cells that originate from neuroendocrine cells. It is considered a high-grade tumor, meaning it grows and spreads more quickly than low-grade tumors. The disease often begins in the central part of the lungs and can spread to other parts of the body. Symptoms may include cough, chest pain, and difficulty breathing. As the disease progresses, it can lead to more severe respiratory issues and other systemic symptoms. The progression of this carcinoma is typically aggressive, with a tendency to metastasize early.