Not recruiting

Study to Test Pembrolizumab, MK-4830, and MK-0482 in Patients with Advanced Non-Small Cell Lung Cancer Who Have Not Received Prior Treatment

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 treatments for Non-small Cell Lung Cancer (NSCLC), a common type of lung cancer. The study involves the use of several investigational medications, including pembrolizumab (also known as KEYTRUDA), MK-4830, and rolistobart (also known as MK-0482). These medications are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well these treatments work in patients who have not received prior treatment for their advanced NSCLC and whose tumors have a specific protein called PD-L1. The study will explore different combinations of these medications to see which is most effective. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the investigational drugs.

Participants in the study will receive treatment over a period of time, with regular monitoring to assess their response to the medication. The study aims to understand the objective response rate, which is a measure of how the cancer responds to the treatment. Additionally, the study will track progression-free survival, which is the length of time during and after treatment that a patient lives with the disease without it getting worse, and any adverse events, which are side effects or any unwanted effects of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of treatment
Upon joining the study, you will begin treatment for advanced non-small cell lung cancer (NSCLC).
The treatment involves receiving medications through an intravenous (IV) infusion. This means the medication is given directly into your vein using a needle.
Step 2
Medication administration
You will receive a combination of investigational agents with pembrolizumab, also known as KEYTRUDA, or pembrolizumab alone.
The medications include pembrolizumab, MK-4830, and rolistobart. All are administered as a solution for infusion.
Step 3
Treatment schedule
The frequency and duration of the medication administration will be determined by the study protocol. This will be explained to you by the study team.
Regular visits to the clinic will be required for the administration of the medication and for monitoring your health.
Step 4
Monitoring and assessments
Throughout the trial, your response to the treatment will be assessed using specific criteria to evaluate the size and progression of the tumor.
You will also be monitored for any side effects or adverse events that may occur during the treatment.
Step 5
End of treatment
The study is expected to continue until November 2026, but your participation may end earlier depending on your response to the treatment or if you experience any significant side effects.
After completing the treatment, follow-up visits may be scheduled to monitor your health and gather additional information about the long-term effects of the treatment.

Who can join the trial?

9 criteria

Must have a confirmed diagnosis of Stage IV **Non-small Cell Lung Cancer (NSCLC)**, which is a type of lung cancer.
If you have non-squamous NSCLC, you must not be eligible for an approved targeted therapy, which is a specific type of cancer treatment.
Must be able to provide a sample of your tumor tissue. This can be an old sample taken within the last 5 years, a sample taken after your last treatment but before the study screening, or a new sample taken within 90 days before starting the study.
Must not have received any previous systemic treatment for metastatic NSCLC. Systemic treatment is a type of cancer treatment that affects the whole body.
Must have a **PD-L1 tumor proportion score (TPS)** of 1% or higher. PD-L1 is a protein that can affect how your immune system fights cancer.
Must be able to complete all screening procedures within a 35-day period before starting the study.
Male participants must agree to use contraception and not donate sperm during the study and for at least 120 days after the last dose of the study treatment.
Female participants must not be pregnant or breastfeeding. They must either not be able to have children or agree to use contraception during the study and for at least 120 days after the last dose of the study treatment.
Must have adequate organ function within 10 days before starting the study treatment. This means your organs, like your liver and kidneys, are working well enough.

Who cannot join the trial?

9 criteria

Patients with any other type of cancer besides Non-small Cell Lung Cancer (NSCLC) cannot participate.
Patients who have had another cancer within the last 5 years, except for skin cancer that is not melanoma, cannot participate.
Patients who have received any other cancer treatment within the last 4 weeks cannot participate.
Patients with uncontrolled or serious heart problems cannot participate.
Patients with active infections that require treatment cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with known allergies to the study medication cannot participate.
Patients who have participated in another clinical trial within the last 4 weeks cannot participate.
Patients with any condition that the study doctors believe would make it unsafe for them to participate cannot participate.

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Verified sites

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

Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Verified
Rome, Italy
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Verified
Gyor, Hungary

Trial locations

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Investigated drugs

Pembrolizumab
is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. It targets a specific protein on the surface of cancer cells, which helps your immune system recognize and attack these cells more effectively. This medication is used in the trial to see if it can help treat advanced non-small cell lung cancer, either on its own or in combination with other treatments.
Chemotherapy
is a treatment that uses drugs to kill cancer cells. It works by targeting and destroying rapidly dividing cells, which include cancer cells. In this trial, chemotherapy is used in combination with pembrolizumab to see if the combination is more effective in treating advanced non-small cell lung cancer than using pembrolizumab alone.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently a well-established medication in the treatment of various cancers, including non-small cell lung cancer (NSCLC), and is frequently discussed in medical literature. The main therapeutic use of pembrolizumab is to treat advanced NSCLC, particularly in patients who have not received prior treatment and have tumors expressing PD-L1. At the molecular level, pembrolizumab works by blocking a specific protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

Investigated diseases

Non-small Cell Lung Cancer (NSCLC) – 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 generally starts in the epithelial cells lining the lungs and can grow and spread to other parts of the body. The disease often progresses slowly compared to small cell lung cancer, but it can vary depending on the subtype and individual factors. As the cancer grows, it may cause symptoms like persistent cough, chest pain, and difficulty breathing. Over time, it can invade nearby tissues and organs, potentially leading to further complications. The progression of NSCLC is typically assessed using imaging techniques and specific criteria to evaluate tumor size and spread.