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Study on Pembrolizumab as Maintenance Therapy for Patients with Unresectable Stage III Non-Small Cell Lung Cancer After Chemo-Radiotherapy

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 non-small cell lung cancer (NSCLC). The study is specifically for patients with stage III NSCLC that cannot be removed by surgery. The treatment being tested is called Pembrolizumab, also known by its code name MK-3475. Pembrolizumab is a medication given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to see if using Pembrolizumab as a maintenance therapy after patients have received a combination of chemotherapy and radiation therapy can help improve their overall survival. The study will compare two groups of patients: one group will receive Pembrolizumab for up to 24 months, while the other group will be observed without additional treatment after their initial therapy. This will help researchers understand if Pembrolizumab can provide better outcomes for patients with this type of lung cancer.

Participants in the study will first undergo chemotherapy and radiation therapy. After this initial treatment, they will either receive Pembrolizumab or be placed under observation. The study will monitor the patients over time to assess their overall survival and how long they remain free from cancer progression. The goal is to determine if Pembrolizumab can extend the lives of patients with stage III NSCLC compared to those who do not receive the maintenance therapy.

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
Initiation of treatment
The treatment begins with a combination of chemotherapy and radiotherapy. This phase is designed to target the cancer cells in the lung.
The duration of this initial treatment phase is determined by the healthcare provider based on individual patient needs and response to therapy.
Step 2
Maintenance therapy with pembrolizumab
Following the completion of chemo-radiotherapy, the next phase involves maintenance therapy using pembrolizumab.
Pembrolizumab is administered as an intravenous infusion. This means the medication is given directly into a vein through a drip.
The dosage is 25 mg/mL, and the treatment can continue for up to 24 months, depending on the patient's response and tolerance.
Step 3
Monitoring and follow-up
Throughout the trial, regular monitoring is conducted to assess the patient's health and the effectiveness of the treatment.
This includes routine check-ups, imaging tests, and laboratory tests to track the progress of the disease and any side effects of the treatment.
Step 4
Completion of trial
The trial is expected to conclude by December 31, 2024.
Upon completion, the patient's overall survival and response to the treatment will be evaluated to determine the success of the therapy.

Who can join the trial?

9 criteria

Be willing and able to provide written informed consent or agreement to participate in the trial.
Be at least 18 years old on the day of signing the informed consent.
Have a disease that can be measured using a specific method called RECIST 1.1.
Be willing to provide a sample of tissue from a newly obtained biopsy of a tumor. A biopsy is a small sample of tissue taken from the body to be examined. If a new sample cannot be provided due to safety concerns or other reasons, an older sample may be used with permission.
Have a performance status of 0 or 1 on the ECOG Performance Scale, which is a way to measure how well a person can perform daily activities.
Show that organs are working well enough, as defined by specific tests done within 10 days before starting treatment.
Female participants who can have children should have a negative pregnancy test within 72 hours before receiving the first dose of study medication. If the urine test is positive or unclear, a blood test will be needed.
Female participants who can have children should agree to use two methods of birth control, be surgically sterile, or not engage in heterosexual activity during the study and for 120 days after the last dose of study medication. Participants who can have children are those who have not been surgically sterilized or have not had a period for more than one year.
Male participants should agree to use an effective method of contraception starting with the first dose of study therapy and continuing for 120 days after the last dose of study therapy.

Who cannot join the trial?

7 criteria

Patients with medical conditions other than non-Small Cell Lung Cancer cannot participate. This type of cancer affects the lungs and is not the same as other types of lung cancer.
Patients who have had surgery to remove their lung cancer are not eligible. The study is for those with unresectable cancer, meaning it cannot be removed by surgery.
Patients who are not in stage IIIA-B of their lung cancer cannot join. This stage indicates a specific level of cancer spread.
Patients who are not receiving chemo-radiotherapy cannot participate. This is a treatment that combines chemotherapy (using drugs to kill cancer cells) and radiation therapy (using high-energy rays to kill cancer cells).
Patients who cannot undergo treatment with Pembrolizumab (MK-3475) are excluded. Pembrolizumab is a medication used to help the immune system fight cancer.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.

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Verified sites

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

Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Verified
Turin, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Azienda Ospedaliero Universitaria Di Modena
Verified
Modena, Italy

Trial locations

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Investigated drugs

Pembrolizumab is a medication used in this clinical trial as a maintenance therapy for patients with a specific type of lung cancer that cannot be removed by surgery. It is given to patients after they have completed a combination of chemotherapy and radiation therapy. The goal of using Pembrolizumab is to help improve the overall survival of patients by continuing to target and fight cancer cells for up to 24 months.

Pembrolizumab

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently being studied in clinical trials for its effectiveness as a maintenance therapy in patients with unresectable stage III non-small cell lung cancer (NSCLC) who have already undergone chemo-radiotherapy. The main therapeutic indication for Pembrolizumab in this context is to improve overall survival in these patients. At the molecular level, Pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. In its early stages, it may not cause noticeable symptoms, but as it progresses, it can lead to coughing, chest pain, and difficulty breathing. The progression of the disease can vary, with some tumors growing slowly and others spreading more rapidly. Understanding the specific subtype and stage of the cancer is crucial for determining its progression.