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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Koranyi National Institute For Pulmonology	Budapest	Hungary

Other Sites

Site Name	City	Country
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok	Hungary
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Matrai Gyogyintezet	Gyongyos	Hungary
Semmelweis University	Budapest	Hungary
Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Hungary
Tuedogyogyintezet Toeroekbalint	Torokbalint	Hungary
Cardiomed S.R.L.	Cluj Napoca	Romania
Mmprfhv Cjeiqe Glax Skzktv	Ploiesti	Romania
Babzeuhhqat Vuruhobuq Ojmkfhditkma	Kecskemet	Hungary
Gcarjdsnvllcfmrvl Virmquhij Pphf Ajuavf Exwdqrlb Ozliuf Khmutk	Gyor	Hungary

Trial status

Country	Status	Recruitment Start
Hungary	Not recruiting	07.04.2021
Romania	Not recruiting	07.04.2021

Trial locations

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.

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.

Trial ID:

2023-505362-28-00

Protocol code:

MK-7684A-003

NCT ID:

NCT04738487

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?