Not recruiting

Study Comparing MK-7684A and Pembrolizumab for Patients with PD-L1 Positive Metastatic Non-Small Cell Lung Cancer

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 Stage IV non-small cell lung cancer, a type of lung cancer that has spread to other parts of the body. The study is comparing two treatments: a combination of two medications, MK-7684A (which includes pembrolizumab and vibostolimab), and pembrolizumab alone. Pembrolizumab is a medication that helps the immune system fight cancer cells, while vibostolimab is a newer drug being tested for its potential to enhance this effect.

The purpose of the study is to see which treatment is more effective for patients with a specific type of lung cancer that shows a protein called PD-L1. This protein can affect how the immune system responds to cancer. Participants in the study will receive either the combination treatment or pembrolizumab alone. The study will monitor how long patients live and how long they live without the cancer getting worse. It will also look at the overall response to the treatment and any side effects experienced.

Participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over a period of time, with regular check-ups to monitor the effects of the treatment. The goal is to find out if the combination of MK-7684A is more effective than pembrolizumab alone in treating this type of lung cancer. The study will help doctors understand which treatment might be better for patients with Stage IV non-small cell lung cancer that is PD-L1 positive.

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
Joining the study
Upon joining the study, the participant is confirmed to have Stage IV non-small cell lung cancer. The participant's cancer must express a protein called PD-L1 in at least 1% of tumor cells.
The participant must have a performance score indicating they are fully active or restricted in physically strenuous activity but ambulatory.
Step 2
Randomization
The participant is randomly assigned to one of two groups: one receiving a combination of MK-7684A and pembrolizumab, and the other receiving pembrolizumab alone.
This process is double-blind, meaning neither the participant nor the researchers know which treatment the participant receives.
Step 3
Treatment administration
The treatment is administered as an intravenous infusion. This means the medication is given directly into a vein through a needle.
The specific dosage and frequency of the infusion are determined by the study protocol and are administered at regular intervals.
Step 4
Monitoring and assessments
Throughout the study, the participant undergoes regular assessments to monitor the cancer's response to treatment. This includes imaging tests and other evaluations.
The participant's overall health and any side effects experienced are closely monitored.
Step 5
Completion of treatment
The treatment continues until the study's end date or until the participant's doctor determines it is no longer beneficial.
The study is estimated to conclude in June 2028, but individual participation may end earlier based on specific circumstances.

Who can join the trial?

8 criteria

The patient must have a confirmed diagnosis of **Stage IV non-small cell lung cancer**. This means the cancer has spread to other parts of the body.
The patient must have a **measurable disease**. This means the cancer can be measured using specific medical criteria.
The patient must not need specific treatments for certain gene changes in the cancer, like **EGFR**, **ALK**, or **ROS1**. These are specific genes that can affect cancer growth.
The patient must provide a sample of their tumor that shows **PD-L1 expression** in at least 1% of the tumor cells. PD-L1 is a protein that can affect how the immune system responds to cancer.
The patient must have an **ECOG performance score** of 0 or 1. This score measures how well the patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
The patient must have a **life expectancy** of at least 3 months.
If the patient is a woman, she must not be pregnant or breastfeeding. If she can have children, she must use a highly effective birth control method or be abstinent during the study and for at least 120 days after the last dose of the study drug.
The patient must have **adequate organ function**. This means the organs are working well enough to handle the treatment.

Who cannot join the trial?

6 criteria

Patients who have a different type of cancer than Stage IV non-small-cell lung cancer cannot participate. This is a specific type of lung cancer that has spread to other parts of the body.
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 not able to provide informed consent or understand the study requirements cannot participate. This means they need to be able to understand what the study involves and agree to take part.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients who have certain medical conditions or are taking medications that might interfere with the study cannot participate. This is to ensure accurate results and the safety of the participants.
Patients who have participated in another clinical trial recently may not be eligible. This is to avoid any interference with the results of the study.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Verified
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemet, Hungary
Verified
Centrul De Oncologie SF Nectarie S.R.L.
Craiova, Romania
Responsive
Semmelweis University
Budapest, Hungary

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

MK-7684A
is a combination medication used in this clinical trial. It is being studied to see how effective it is when used together with another medication, pembrolizumab, for treating patients with a specific type of lung cancer called PD-L1 positive metastatic non-small cell lung cancer. The goal is to determine if this combination can help patients live longer or delay the progression of their cancer compared to using pembrolizumab alone.
Pembrolizumab
is a medication that is already used to treat certain types of cancer, including non-small cell lung cancer. It works by helping the immune system recognize and attack cancer cells. In this trial, pembrolizumab is being used as a comparison to see if the combination with MK-7684A offers any additional benefits for patients with PD-L1 positive metastatic non-small cell lung cancer.

What is already known about the treatment

MK-7684A
This medication is administered as an intravenous infusion and is currently being studied in clinical trials for its effectiveness in treating stage IV non-small cell lung cancer. It is a combination of MK-7684 with pembrolizumab, designed to enhance the immune system's ability to fight cancer by targeting specific proteins on cancer cells. The main therapeutic indication is for patients with PD-L1 positive metastatic non-small cell lung cancer. MK-7684A works by blocking the interaction between PD-1 and PD-L1 proteins, which helps activate T-cells to attack cancer cells. It is classified as an immunotherapy agent.
Pembrolizumab
This medication is also administered as an intravenous infusion and is widely used in the treatment of various cancers, including non-small cell lung cancer. It is an established medication in medical literature and is used as a monotherapy in this clinical trial. Pembrolizumab is indicated for patients with PD-L1 positive metastatic non-small cell lung cancer. It functions by inhibiting the PD-1 protein on T-cells, thereby enhancing the immune response against cancer cells. Pembrolizumab is classified as a checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Stage IV Non-Small Cell Lung Cancer – This is an advanced form of lung cancer where the disease has spread beyond the lungs to other parts of the body. It typically begins in the cells lining the air passages and can grow and spread rapidly. As the cancer progresses, it may invade nearby tissues and organs, leading to symptoms such as persistent cough, chest pain, and difficulty breathing. The spread of cancer to distant organs, such as the brain or bones, can cause additional symptoms depending on the affected area. The progression of the disease can vary, with some patients experiencing a gradual worsening of symptoms, while others may have a more rapid decline. The disease is often categorized by the presence of specific proteins, such as PD-L1, which can influence its behavior and response to certain treatments.