Study Comparing MK-7684A with Chemotherapy to Pembrolizumab with Chemotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying treatments for Metastatic Non-Small Cell Lung Cancer, a type of lung cancer that has spread to other parts of the body. The study is comparing two treatment options. The first option is a combination of a new drug called MK-7684A, which is a coformulation of Pembrolizumab and Vibostolimab, along with chemotherapy. The second option is Pembrolizumab combined with chemotherapy. Chemotherapy involves using drugs to kill cancer cells and is a common treatment for various types of cancer.

The purpose of this study is to compare the effectiveness of these two treatment options in terms of how long patients live. Participants will receive their assigned treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will follow participants over a period to monitor their health and any changes in their condition. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

Throughout the study, researchers will collect information on various aspects of the participants’ health, including their overall survival, progression of the disease, and quality of life. This information will help determine which treatment option is more effective for patients with Metastatic Non-Small Cell Lung Cancer. The study aims to provide valuable insights that could improve treatment strategies for this type of cancer in the future.

1 joining the study

Upon joining the study, a diagnosis of Stage IV non-small cell lung cancer (NSCLC) is confirmed. This is a type of lung cancer that has spread to other parts of the body.

Eligibility is determined based on specific criteria, including not having received prior treatment for metastatic NSCLC and having a life expectancy of at least 3 months.

2 treatment initiation

The treatment involves receiving medications through an intravenous infusion. This means the medication is delivered directly into the bloodstream through a vein.

The medications used include pembrolizumab and vibostolimab in combination with chemotherapy drugs such as paclitaxel, carboplatin, and cisplatin.

3 treatment schedule

The treatment is administered in cycles. Each cycle typically lasts for a few weeks, during which the medications are given on specific days followed by a rest period.

The exact schedule and dosage depend on the specific treatment plan designed for the individual.

4 monitoring and assessments

Regular monitoring is conducted to assess the response to treatment. This includes imaging tests to measure the size of the cancer and blood tests to check overall health.

Quality of life is also evaluated using questionnaires that assess physical functioning, pain, and other symptoms.

5 end of treatment

The treatment continues until the cancer progresses, unacceptable side effects occur, or the study ends.

The estimated end date for the study is October 25, 2027.

Who Can Join the Study?

Must have a confirmed diagnosis of Stage IV squamous or non-squamous NSCLC. NSCLC stands for Non-Small Cell Lung Cancer, and Stage IV means the cancer has spread to other parts of the body.
Must not have received any previous treatment for metastatic NSCLC. Metastatic means the cancer has spread from its original location to other parts of the body.
Must have a disease that can be measured based on RECIST 1.1. This is a set of guidelines used to measure how well a cancer treatment is working.
Must have a life expectancy of at least 3 months.
For males: Must use contraception unless confirmed to be azoospermic. Azoospermic means having no sperm in the semen.
For females: Women who can have children must use a highly effective method of contraception.

Who Cannot Join the Study?

Patients with other types of cancer besides Metastatic Non-Small Cell Lung Cancer cannot participate. Metastatic means the cancer has spread to other parts of the body.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study.
Patients who are part of a vulnerable population, which may include groups like pregnant women or those unable to give consent, cannot participate.
Patients who have medical conditions or are taking medications that might interfere with the study treatment cannot participate.
Patients who have previously received certain treatments that could affect the study results cannot participate.
Patients who are unable to follow the study procedures or attend required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Medical University Of Graz	Graz	Austria
Comite Entreprise Paul Papin	Angers	France
Hospital Clinico San Carlos	Madrid	Spain
Medizinische Universitaet Innsbruck	Innsbruck	Austria

Other Sites

Site Name	City	Country
Centre Hospitalier D Avignon	Avignon	France
HIA Sainte Anne	Toulon	France
Szpital Specjalistyczny W Prabutach Sp. z o.o.	Prabuty	Poland
Med Polonia Sp. z o.o.	Poznan	Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
SRH Wald-Klinikum Gera GmbH	Gera	Germany
Deutsches Herzzentrum Berlin	Berlin	Germany
Krankenhaus Nord Klinik Floridsdorf	Vienna	Austria
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
GEFOS Gesellschaft fuer onkologische Studien Dortmund mbH	Dortmund	Germany
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Centrum Pulmonologii I Torakochirurgii W Bystrej	Wilkowice	Poland
Pbcialagiwv Lalzwqvx &ryaqtpnbmwteffjpojo Rqcyu Kunurgosmzy	Konin	Poland
Cswwua Ldxz Bgzwvn	Lyon	France
Ogizrcwrceqnur Lzsn Gkna	Linz	Austria
Hwkafmsh Vqlw dxzazesz	Barcelona	Spain
Hssqvoza Uzlmirynkfvrl dl A Ccdpcb	A Coruna Galicia	Spain
Wsjrhpqzmn Stzpttn Ikj Smccuxl Pxu W Pqibssvwb	Przemysl	Poland

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	24.03.2022
France	Not recruiting	24.03.2022
Germany	Not recruiting	24.03.2022
Poland	Not recruiting	24.03.2022
Spain	Not recruiting	24.03.2022

Trial locations

Investigated drugs:

Pembrolizumab is a medication used in this trial to help the immune system fight cancer cells. It is often used in combination with other treatments to improve its effectiveness against certain types of cancer, such as non-small cell lung cancer.

Vibostolimab is part of a coformulation with pembrolizumab in this study. It is designed to work alongside pembrolizumab to enhance the immune response against cancer cells, potentially improving treatment outcomes for patients with metastatic non-small cell lung cancer.

MK-7684A is the code name for the coformulation of pembrolizumab and vibostolimab. This combination is being tested to see if it provides better results when used with chemotherapy compared to pembrolizumab with chemotherapy alone.

Chemotherapy refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used in combination with other medications to treat metastatic non-small cell lung cancer, aiming to improve survival rates and reduce cancer progression.

Investigated diseases:

Non-small cell lung cancer metastatic

Metastatic Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells of the lungs and has spread to other parts of the body. It is the most common type of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and form tumors in the lungs, which can then spread to lymph nodes and other organs such as the brain, bones, and liver. Symptoms may include a persistent cough, chest pain, shortness of breath, and unexplained weight loss. As the cancer spreads, it can cause additional symptoms depending on the organs affected. The progression of the disease can vary greatly among individuals.

Trial ID:

2023-506074-12-00

Protocol code:

MK-7684A-007

NCT ID:

NCT05226598

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing MK-7684A with Chemotherapy to Pembrolizumab with Chemotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

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