Recruiting

Study on Tislelizumab and Chemotherapy for Patients with Stage III PD-L1 Positive Non-Small Cell Lung Cancer

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 stage III PD-L1 positive Non-Small Cell Lung Cancer (NSCLC). The study will explore the effects of a treatment that combines a medication called tislelizumab with a type of chemotherapy known as platinum-based doublet chemotherapy. The chemotherapy drugs involved in this study include Pemetrexed, Cisplatin, Carboplatin, and Paclitaxel. These medications are given as a solution through an IV infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well this combination of treatments works in preparing patients for surgery. The study will look at how many patients can have a complete removal of their tumor through surgery after receiving the treatment. Participants will receive the treatment over a period of time before undergoing surgery. The study will also monitor other outcomes, such as the reduction of cancer in the lymph nodes, the response of the tumor to the treatment, and the overall survival of the patients.

Throughout the study, participants will receive regular assessments to monitor their health and the progress of the treatment. The study aims to provide valuable information on the effectiveness of combining tislelizumab with chemotherapy in treating this specific type of lung cancer, potentially leading to improved treatment options for patients in the future.

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 informed about the trial's purpose and procedures. You will be required to provide written informed consent, confirming your understanding and willingness to participate.
Step 2
Initial assessments
You will undergo a series of initial assessments to confirm your eligibility. These assessments include a review of your medical history, a physical examination, and specific tests to confirm the stage of your condition and your overall health status.
Step 3
Treatment phase
During the treatment phase, you will receive a combination of medications through IV infusion. The medications include pemetrexed, cisplatin, carboplatin, tislelizumab, and paclitaxel. The exact dosage and frequency will be determined by the study team based on your specific needs.
This phase is designed to prepare you for potential surgery by reducing the size of the tumor.
Step 4
Monitoring and follow-up
Throughout the trial, your health and response to the treatment will be closely monitored. Regular follow-up visits will be scheduled to assess your progress and manage any side effects.
These visits will include physical exams, imaging tests, and laboratory tests to evaluate the effectiveness of the treatment.
Step 5
Surgery evaluation
After completing the treatment phase, you will be evaluated for surgery. The goal is to achieve a complete tumor resection, meaning no visible cancer remains after surgery.
The decision for surgery will be based on the reduction of the tumor size and your overall health status.
Step 6
Post-treatment follow-up
Following the surgery, you will continue to be monitored to assess your recovery and any long-term effects of the treatment.
Regular follow-up visits will be scheduled to ensure your continued health and to detect any signs of cancer recurrence.

Who can join the trial?

11 criteria

Must have a confirmed diagnosis of stage III disease.
Must be at least 18 years old.
Must provide written informed consent to participate.
Must have a PD-L1 TPS (a type of protein test) of 1% or higher according to local testing.
Must not have evidence of EGFR mutations or ALK, ROS1, or RET rearrangements (specific genetic changes) by local testing.
Must undergo a baseline multidisciplinary assessment to confirm suitability for treatment aimed at curing the disease.
Must have pulmonary function tests (lung tests) done within 6 months of the planned surgery.
Must have at least one measurable lesion (a tumor that can be measured) as defined by RECIST v1.1 (a standard way to measure tumor size).
Must have an ECOG Performance Status of 0 or 1 (a scale to assess how the disease affects daily living).
Must be eligible to receive a platinum doublet chemotherapy regimen (a specific type of cancer treatment).
Must have adequate organ function as shown by laboratory tests done within 14 days before the first dose of the study drug.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer besides stage III PD-L1 positive Non-Small Cell Lung Cancer (NSCLC) cannot participate.
Patients who have had previous treatment for their lung cancer are not eligible.
Patients with serious heart problems, such as heart failure or a recent heart attack, cannot join the study.
Patients with uncontrolled high blood pressure are not allowed to participate.
Patients with active infections, including HIV, hepatitis B, or hepatitis C, are excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients with autoimmune diseases, which are conditions where the immune system attacks the body, are not eligible.
Patients who have had an organ transplant cannot participate.
Patients with a history of severe allergic reactions to similar drugs are excluded.
Patients who are currently participating in another clinical trial are not allowed to join.

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Verified sites

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

Fondazione I.R.C.C.S. Istituto Neurologico Besta
Verified
Milan, Italy
I.F.O. Istituti Fisioterapici Ospitalieri
Verified
Rome, Italy
Ospedale San Raffaele S.r.l.
Verified
Milan, Italy

Trial locations

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Investigated drugs

Tislelizumab
is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, it is used to treat patients with a specific type of lung cancer called PD-L1 positive Non-Small Cell Lung Cancer (NSCLC). The goal is to help your body fight the cancer more effectively before surgery.
Platinum-based doublet chemotherapy
is a combination of two chemotherapy drugs that contain platinum. These drugs work together to kill cancer cells or stop them from growing and dividing. In this trial, they are used alongside immunotherapy to shrink the tumor and make it easier to remove during surgery. This approach aims to improve the chances of a successful surgery and better outcomes for patients with lung cancer.

What is already known about the treatment

Tislelizumab – Tislelizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating stage III PD-L1 positive Non-Small Cell Lung Cancer (NSCLC). The main therapeutic use of tislelizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1 on immune cells, which can otherwise prevent the immune system from attacking cancer cells. Tislelizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

Investigated diseases

Stage III PD-L1 positive Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer characterized by the presence of PD-L1 protein on the surface of cancer cells, which can affect the immune system's ability to attack the tumor. In stage III, the cancer has spread to nearby lymph nodes or other structures within the chest but not to distant parts of the body. The disease often begins with symptoms such as a persistent cough, chest pain, or difficulty breathing. As it progresses, it may cause more severe respiratory issues and general symptoms like fatigue or weight loss. The cancer cells can grow and invade nearby tissues, making it more challenging to manage. The progression of the disease can vary, with some cases remaining stable for a period while others may advance more rapidly.