Recruiting

Study on the Safety of Tremelimumab Injections for Early-Stage Non-Small Cell Lung Cancer Patients

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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 Non-Small Cell Lung Cancer (NSCLC), which is a common type of lung cancer. The treatment being investigated is called Tremelimumab, a medication that is administered as a solution for infusion. The study aims to explore the safety and feasibility of injecting Tremelimumab directly into the lymph nodes or tumors of patients with early-stage NSCLC using a method called transbronchial needle injection.

Participants in the study will receive either Tremelimumab or a saline solution, which is a simple saltwater solution, through a needle inserted into the lymph nodes or tumors. The study will monitor the safety of this procedure by observing any adverse effects that may occur. Additionally, the study will assess how well the procedure can be performed and whether the medication can be successfully delivered to the targeted areas.

The study will also involve checking the levels of therapeutic antibodies in the blood at various times after the procedure to understand how the body processes the medication. This will help researchers gather important information about the treatment's effects and its potential use in managing early-stage NSCLC.

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 study
Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the details and potential risks of the study.
You must be at least 18 years old and have a confirmed diagnosis of early-stage non-small cell lung cancer (NSCLC) that is scheduled for surgical removal.
Step 2
Initial assessment
An initial assessment will be conducted to ensure you meet all the criteria for participation. This may involve reviewing your medical history and conducting necessary tests.
Step 3
Treatment administration
You will receive an injection of the study medication, tremelimumab, directly into the lymph node or tumor using a procedure called transbronchial needle injection (TBNI).
The medication is administered as a solution for infusion and is designed to study its safety and feasibility in treating early-stage NSCLC.
Step 4
Monitoring and follow-up
After the injection, you will be monitored for any adverse effects. This includes checking for any severe reactions related to the procedure or the medication.
Blood samples will be taken at various times: immediately after the procedure, 2 hours later, 1 day later, 14 days later, and 12 weeks after your surgery. These samples help assess the levels of the medication in your body.
Step 5
Surgical tumor resection
You will undergo the planned surgical removal of your lung tumor. This is a standard procedure for treating your condition.
Step 6
Final assessment
A final assessment will be conducted to evaluate the overall safety and effectiveness of the treatment. This includes reviewing any side effects and the success of the medication administration.

Who can join the trial?

6 criteria

Must have a confirmed diagnosis of a specific type of lung cancer called non-small cell lung cancer (NSCLC).
The cancer must be in an early stage, specifically classified as T1-2N0M0, which means the tumor is small and has not spread to lymph nodes or other parts of the body.
Must be scheduled for a surgical removal of the lung tumor.
Must be willing and able to sign a document that shows you understand the study and agree to participate, known as informed consent.
Must be 18 years or older at the time of signing the informed consent.
Must be considered a suitable candidate for the lung surgery by a team of doctors, including a lung specialist and surgeons, during a meeting where they discuss the best treatment options.

Who cannot join the trial?

8 criteria

Patients with any other type of cancer besides non-small cell lung cancer.
Patients who are not in the early stages of non-small cell lung cancer.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, such as those unable to give consent.
Patients who have any medical condition that the study doctors think would make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a history of severe allergic reactions to similar treatments.

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Verified sites

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Amsterdam UMC
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Amsterdam, The Netherlands

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Investigated drugs

Tremelimumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, tremelimumab is being injected directly into the lymph nodes and tumors of patients with early-stage non-small cell lung cancer (NSCLC) using a special technique called transbronchial needle injection. This approach aims to see if the medication can be safely delivered in this way and if it can help the immune system fight the cancer more effectively.

What is already known about the treatment

Tremelimumab – Tremelimumab is administered through a procedure called transbronchial needle injection, which involves delivering the medication directly into the lymph nodes or tumor tissue in the lungs. It is currently being studied in clinical trials for its safety and feasibility in treating early-stage non-small cell lung cancer (NSCLC). The main therapeutic use of tremelimumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein that usually helps keep the immune system in check, allowing the immune cells to target cancer more effectively. Tremelimumab is classified as an immunotherapy drug, specifically a monoclonal antibody, which is a type of medication designed to target specific proteins in the body.

Investigated diseases

Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the epithelial cells lining the lungs and is characterized by the uncontrolled growth of abnormal cells. As the disease progresses, these cancerous cells can form tumors and potentially spread to other parts of the body. NSCLC often grows and spreads more slowly than small cell lung cancer. The progression of NSCLC can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. Over time, the disease may invade nearby tissues and organs, complicating the patient's condition.