Study on the Effectiveness of Pembrolizumab with Chemotherapy in Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Levels

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What is this study about?

This clinical trial is focused on studying treatments for non-small cell lung cancer (NSCLC), a type of lung cancer. The study will explore the effectiveness of different medications, including Cisplatin, Pemetrexed, Pembrolizumab (also known by its code name MK-3475), Paclitaxel, and Carboplatin. These medications are administered as solutions for infusion, which means they are given directly into the bloodstream through a vein.

The purpose of the study is to assess and compare the effectiveness of two treatment strategies for patients with advanced NSCLC that have a high level of a protein called PD-L1. The study will involve a series of treatments over a period of time, with some patients receiving a combination of medications and others receiving a single medication. The study will also include a group of patients who will receive a placebo. The goal is to determine which treatment strategy is more effective in controlling the disease.

Participants in the study will receive treatment over several weeks, with regular monitoring to assess how well the treatment is working. The study will measure various outcomes, such as how long patients live without the disease getting worse and the overall response to the treatment. The study is expected to continue until early 2026, with the aim of providing valuable information on the best treatment options for patients with advanced NSCLC.

1 initial visit

Upon joining the clinical trial, you will attend an initial visit. During this visit, you will undergo a series of tests to confirm your eligibility. These tests will include a review of your medical history, a physical examination, and laboratory tests to ensure your organs are functioning properly.

You will also be required to provide written informed consent, indicating your understanding and agreement to participate in the trial.

2 treatment initiation

Once eligibility is confirmed, you will begin the treatment phase. The treatment involves receiving medications through an infusion, which is a method of delivering drugs directly into your bloodstream.

The medications used in this trial include cisplatin, pemetrexed, pembrolizumab, paclitaxel, and carboplatin. The specific combination and dosage will be determined by the study protocol and your medical team.

3 ongoing treatment

Throughout the trial, you will receive regular infusions of the study medications. The frequency and duration of these infusions will be specified by the study protocol.

You will also have regular follow-up visits to monitor your health and the effectiveness of the treatment. These visits will include physical exams, blood tests, and imaging studies as needed.

4 end of treatment

At the end of the treatment phase, you will have a final evaluation to assess your response to the therapy. This will involve similar tests and assessments as conducted during the trial.

Your medical team will discuss the results with you and provide guidance on any further treatment or follow-up care that may be necessary.

5 post-trial follow-up

After completing the trial, you will continue to be monitored for a specified period. This is to ensure your ongoing health and to gather additional data on the long-term effects of the treatment.

You will be required to attend follow-up visits and report any changes in your health to the study team.

Who Can Join the Study?

Diagnosis of non-small cell lung cancer (NSCLC) in stage IIIC or IV.
Female participants who can have children must agree to use two methods of birth control, be surgically sterile, or abstain from heterosexual activity during the study and for 120 days after the last dose of study medication. This applies to those who have not been surgically sterilized or have not had a period for more than one year.
Male participants must agree to use a reliable method of contraception starting with the first dose of study therapy and continuing for 120 days after the last dose.
No history of active cancer that requires treatment.
Must show adequate organ function as defined by specific medical tests, which should be done within 15 days before starting treatment.
Must not have specific genetic changes (driver alterations) for which there is an approved targeted therapy available, such as EGFR, ALK, ROS-1, or BRAF V600E mutations.
Tumor must have PD-L1 levels of 50% or higher, determined by a specific lab test using an anti-PD-L1 antibody.
Must not have received previous systemic treatment for advanced NSCLC.
Must be willing and able to provide written informed consent to participate in the trial.
Must be 18 years of age or older on the day of signing the informed consent.
Must have measurable disease based on specific criteria (RECIST version 1.1). Lesions in areas that were previously treated with radiation may be considered if they have shown progression.
Must have a performance status of 0-1 on the ECOG Performance Scale, which measures daily living abilities.
Female participants who can have children must 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 required.

Who Cannot Join the Study?

Patients with any other type of cancer besides non-small cell lung cancer cannot participate.
Patients with driver alterations in their cancer cells are not eligible. These are specific changes in the cancer’s DNA that can affect how the cancer grows.
Patients who do not have MSC-H are excluded. MSC-H refers to a specific characteristic of the cancer cells.
Patients with a PD-L1 level less than 50% are not eligible. PD-L1 is a protein that can be found on the surface of cancer cells.
Patients who are part of a vulnerable population are not eligible. This means groups of people who might need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	03.04.2023

Trial locations

Investigated drugs:

ICI-CHT is a combination of immune checkpoint inhibitors and chemotherapy. Immune checkpoint inhibitors are a type of medication that helps the body’s immune system recognize and attack cancer cells more effectively. Chemotherapy involves using drugs to kill or slow the growth of cancer cells. In this trial, the combination of these two therapies is being tested to see how well they work together as a first treatment option for patients with a specific type of lung cancer.

ICI-SA stands for immune checkpoint inhibitors with supportive agents. This therapy uses immune checkpoint inhibitors, which help the immune system target and destroy cancer cells. Supportive agents are additional treatments that help manage side effects or enhance the effectiveness of the main therapy. This approach is being evaluated to determine its effectiveness as an initial treatment for patients with a certain type of lung cancer.

Investigated diseases:

Non-small cell lung cancer stage IV

Non-Small Cell Lung Cancer – Non-small cell lung cancer 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 tissues of the lungs and is characterized by the uncontrolled growth of abnormal cells. As the disease progresses, these cancerous cells can form tumors and may spread to other parts of the body, a process known as metastasis. The progression of non-small cell lung cancer can vary depending on the subtype and stage at diagnosis. Early stages may involve localized tumors, while advanced stages often see the cancer spreading to lymph nodes and distant organs. The disease can lead to symptoms such as persistent cough, chest pain, and difficulty breathing as it advances.

Trial ID:

2022-502253-34-00

NCT ID:

NCT00000000

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Pembrolizumab with Chemotherapy in Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Levels

What is this study about?

Who Can Join the Study?

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