Study Comparing Subcutaneous Pembrolizumab with Hyaluronidase to Intravenous Pembrolizumab and Chemotherapy for First-line Treatment of Metastatic Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of 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 forms of the medication pembrolizumab, which is used to help the immune system fight cancer. One form is given as a subcutaneous injection, which means it is injected under the skin, and is known as MK-3475A. The other form is given as an intravenous infusion, meaning it is delivered directly into a vein. Both forms of pembrolizumab are administered alongside chemotherapy, which is a type of cancer treatment that uses drugs to destroy cancer cells.

The purpose of the study is to evaluate the safety and how the body processes these two forms of pembrolizumab when used as a first-line treatment, which means it is the first treatment given for this type of cancer. Participants in the study will receive either the subcutaneous or intravenous form of pembrolizumab, along with chemotherapy, and their health will be monitored over a period of time. The study will look at various factors, such as how much of the drug is present in the body at different times and any side effects that may occur.

Throughout the study, participants will receive regular medical check-ups and tests to monitor their response to the treatment. The study aims to provide valuable information on the effectiveness and safety of these treatment options for people with metastatic non-small cell lung cancer. This research could help improve treatment strategies and outcomes for patients with this condition in the future.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will be asked to provide a tumor tissue sample, either from a previous biopsy or a new one, to confirm your diagnosis of non-small cell lung cancer.

2 initial assessment

An initial assessment will be conducted to evaluate your health status and ensure you meet the study’s eligibility criteria. This includes confirming a life expectancy of at least three months.

3 treatment phase

You will receive treatment with pembrolizumab, which is a medication administered either subcutaneously (under the skin) or intravenously (through a vein). The specific form and dosage will be determined by the study protocol.

In addition to pembrolizumab, you will receive chemotherapy. The chemotherapy drugs may include cisplatin, carboplatin, paclitaxel, or pemetrexed, administered intravenously. The exact combination and schedule will be explained to you by the study team.

4 monitoring and follow-up

Throughout the study, your health and response to treatment will be closely monitored. This includes regular blood tests, imaging scans, and assessments of your overall well-being.

You will be asked to report any side effects or changes in your health to the study team promptly.

5 completion of treatment

Once the treatment phase is complete, you will undergo a final assessment to evaluate the outcomes of the study treatment.

The study team will discuss the results with you and provide guidance on any further medical care you may need.

Who Can Join the Study?

Must have a confirmed diagnosis of Non-small Cell Lung Cancer (NSCLC), which is a type of lung cancer.
Must provide a sample of tumor tissue. This can be from a previous sample or a new biopsy, which is a procedure to remove a small piece of tissue for testing. The sample should not be from an area that has been treated with radiation before.
Must have a life expectancy of at least 3 months.
Open to both male and female participants.
Participants must be adults, as the study includes age ranges for adults.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have received treatment for their cancer before.
Patients with serious heart problems.
Patients with uncontrolled high blood pressure.
Patients with active infections that need treatment.
Patients who are pregnant or breastfeeding.
Patients who have had an organ transplant.
Patients with a history of severe allergic reactions to similar medications.
Patients who are participating in another clinical trial.
Patients with a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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

Other Sites

Site Name	City	Country
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Oncomed S.R.L.	Timisoara	Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok	Hungary
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie	Olsztyn	Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Tuedogyogyintezet Toeroekbalint	Torokbalint	Hungary
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
Semmelweis University	Budapest	Hungary
Bhguhtotain Vlkftrlmg Owszdzzkfbkp	Kecskemet	Hungary
Amrzxsebat Pjuejuuv Hysabhfr Du Pescr	Paris	France
Cokyln Hihiphmjklo Rbmsycwm Uoccjsuvvowto Dq Tmpue	Tours	France
Huiduudp Vbpl dazbkntz	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	13.02.2023
Hungary	Not recruiting	13.02.2023
Poland	Not recruiting	13.02.2023
Romania	Not recruiting	13.02.2023
Spain	Not recruiting	13.02.2023

Trial locations

Investigated drugs:

Pembrolizumab is a type of cancer treatment known as immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, pembrolizumab is given through an intravenous (IV) infusion, which means it is delivered directly into your bloodstream through a vein. This method allows the medication to circulate throughout your body and target cancer cells.

MK-3475A is a new formulation of pembrolizumab that is combined with an enzyme called hyaluronidase. This combination is designed to be given as a subcutaneous (SC) injection, which means it is injected under the skin. The addition of hyaluronidase helps the medication to be absorbed more easily when injected this way. The goal of using MK-3475A is to provide a more convenient way to receive pembrolizumab, potentially with fewer visits to the clinic compared to the IV method.

Metastatic Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the tissues of the lungs and has spread to other parts of the body. It is the most common form of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow uncontrollably and form tumors in the lungs. Over time, these cancer cells can invade nearby tissues and spread to distant organs, such as the brain, bones, and liver. The progression of the disease can lead to symptoms like persistent cough, chest pain, and difficulty breathing. As the cancer advances, it can significantly impact a person’s quality of life and daily functioning.

Trial ID:

2022-501506-36-00

Protocol code:

MK3475A-D77

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Subcutaneous Pembrolizumab with Hyaluronidase to Intravenous Pembrolizumab and Chemotherapy for First-line Treatment of Metastatic Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?