Study on MK-7684A and Docetaxel for Treating Metastatic Non-Small Cell Lung Cancer in Patients After Platinum Chemotherapy and Immunotherapy

2 1 1

What is this study about?

This clinical trial is focused on studying a type of lung cancer known as metastatic non-small cell lung cancer (NSCLC). The study is investigating the effects of a new treatment called MK-7684A, which is a combination of two substances: pembrolizumab and vibostolimab. These substances are designed to help the immune system fight cancer. The trial will compare the effectiveness of MK-7684A when used alone and when combined with another medication called docetaxel, which is a standard treatment for NSCLC. Some participants will receive a placebo, which looks like the treatment but does not contain the active substances.

The purpose of the study is to see if MK-7684A, either alone or with docetaxel, can help stop or slow down the growth of NSCLC better than docetaxel alone. Participants in the study will be randomly assigned to one of the treatment groups. The study will monitor the participants over a period to observe how the cancer responds to the treatments. The trial will also look at the safety of the treatments and any side effects that may occur.

Throughout the study, participants will receive their treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will continue for a set period, and participants will have regular check-ups to assess their health and the progress of their cancer. The results of this study will help determine the potential benefits of MK-7684A for people with metastatic NSCLC.

1 joining the study

Upon joining the study, you will be randomly assigned to one of the treatment groups. This means you will either receive the new drug combination MK-7684A (which includes pembrolizumab and vibostolimab) plus docetaxel, or a placebo (a substance with no active drug) plus docetaxel, or docetaxel alone.

The assignment is random, similar to flipping a coin, and neither you nor the study team will know which group you are in.

2 treatment administration

If you are in the group receiving MK-7684A plus docetaxel, you will receive these medications through an intravenous infusion. This means the medication will be given directly into your vein through a needle.

The frequency and dosage of the medications will be determined by the study protocol, and you will be informed about the schedule by the study team.

3 monitoring and assessments

Throughout the study, your health will be closely monitored. This includes regular visits to the study site for physical exams, blood tests, and imaging tests like CT or MRI scans to check the status of your cancer.

These assessments are important to evaluate how the treatment is affecting your cancer and to monitor for any side effects.

4 end of treatment

The treatment will continue until your doctor determines it is no longer beneficial, or if you experience side effects that require stopping the treatment.

After the treatment ends, you will have follow-up visits to monitor your health and gather information about your overall survival and any long-term effects of the treatment.

Who Can Join the Study?

Must have a confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC). This means the cancer has spread to other parts of the body.
Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use birth control or not have heterosexual intercourse during the study and for a certain period after the last dose of the study drug.
Must have adequate organ function, meaning the organs are working well enough to participate in the study.
Must have confirmation that certain targeted therapies, like those for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or reactive oxygen species (ROS) 1, are not suitable as the main treatment.
Must have disease progression after treatment with one prior anti-programmed cell death 1 (PD-1) or programmed cell death ligand 1 (PD-L1) therapy, which are types of cancer treatments.
Must have disease progression after platinum-based chemotherapy for metastatic disease.
Must have measurable disease, meaning there is at least one tumor that can be measured using a scan like a CT or MRI.
Must provide a sample of tumor tissue for PD-L1 biomarker analysis, which helps in understanding the cancer better.
Must have a life expectancy of at least 3 months.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1, which indicates the level of daily functioning and ability to care for oneself.
Male participants must agree not to donate sperm and either not have heterosexual intercourse or use birth control during the study and for a certain period after the last dose of the study drug.

Who Cannot Join the Study?

Patients who have a different type of cancer than Non-Small Cell Lung Cancer.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or assessments.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medications or similar drugs.
Patients who have received certain treatments for cancer recently.
Patients who have an active infection or other uncontrolled medical conditions.
Patients who have a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Institut Gustave Roussy	Villejuif	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
Centre Hospitalier D Avignon	Avignon	France
Ospedale San Raffaele S.r.l.	Milan	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Centre Hospitalier Le Mans	Le Mans	France
Hospital Universitario Virgen De Valme	Sevilla	Spain
Grand Hopital De Charleroi	Charleroi	Belgium
Clinique Ambroise Pare	Beuvry	France
Les Hopitaux Universitaires De Strasbourg	STRASBOURG, Alsace	France
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Tampere University Hospital	Tampere	Finland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Turku University Hospital	Turku	Finland
Rigshospitalet	Copenhagen	Denmark
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital General Universitario Gregorio Maranon	Madrid	Spain
HELIOS Klinikum Emil von Behring GmbH	Berlin	Germany
Krankenhaus Nord Klinik Floridsdorf	Vienna	Austria
Vitaz	Sint-Niklaas	Belgium
Oulu University Hospital	Oulu	Finland
Vaasa Central Hospital	Vaasa	Finland
Odense University Hospital	Odense	Denmark
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Direction Centrale Du Service De Sante Des Armees	Toulon	France
Hlzseyct Dv Lh Suwns Ciep I Site Pgd	Barcelona	Spain
Aicjwkw Owpfsdzewyc S Gevwkbom Adbeyessqm	Rome	Italy
Eeyhxmi	Mechelen	Belgium

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	15.04.2021
Belgium	Not recruiting	15.04.2021
Denmark	Not recruiting	15.04.2021
Finland	Not recruiting	15.04.2021
France	Not recruiting	15.04.2021
Germany	Not recruiting	15.04.2021
Italy	Not recruiting	15.04.2021
Poland	Not recruiting	15.04.2021
Spain	Not recruiting	15.04.2021

Trial locations

Investigated drugs:

MK-7684A is an experimental medication being tested to see if it can help treat a type of lung cancer called metastatic non-small cell lung cancer. This medication is being studied to understand if it can stop or slow down the growth of cancer cells in patients who have already been treated with other cancer drugs, including chemotherapy and immunotherapy. Researchers are looking at how well this medication works in comparison to other treatments.

Docetaxel is a medication that is already used to treat various types of cancer, including lung cancer. It works by interfering with the growth and spread of cancer cells in the body. In this clinical trial, docetaxel is being used as a standard treatment to compare its effectiveness against the new experimental medication, MK-7684A, to see if the new treatment offers any additional benefits for patients with lung cancer.

Investigated diseases:

Non-small cell lung cancer metastatic

Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer is a type of lung cancer that begins in the tissues of the lungs. It is the most common form of lung cancer, accounting for a majority of cases. The disease progresses as cancer cells grow and form tumors, which can spread to other parts of the body. As the cancer advances, it may invade nearby tissues and organs, leading to further complications. The progression of the disease can vary, with some tumors growing slowly while others may grow more rapidly. The spread of cancer cells to other parts of the body is known as metastasis, which can occur at different stages of the disease.

Trial ID:

2022-501252-28-00

Protocol code:

MK-7684A-002

NCT ID:

NCT04725188

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on MK-7684A and Docetaxel for Treating Metastatic Non-Small Cell Lung Cancer in Patients After Platinum Chemotherapy and Immunotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?