Active not recruitingPHASE3INTERVENTIONAL

A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)

This research study is for people recently diagnosed with non-small cell lung cancer that has spread to other parts of the body. Doctors are trying to find the best ways to treat this type of cancer. Currently, many people receive a medicine called pembrolizumab through a special drip into their vein. This study is testing a new way to give pembrolizumab: as an injection just under the skin. The main goal is to understand how well the injected version works in the body compared to the version given through a drip. They want to learn how much medicine gets into the body and how long it stays there when given in these different ways.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

21 Nov 2024

Estimated completion

11 Feb 2030

Lung Cancer Non-Small Cell Lung Cancer

What is this study about?

This study is looking for new and easier ways to treat a specific type of lung cancer called non-small cell lung cancer (NSCLC), especially when it has spread to other parts of the body. This is often called metastatic cancer. Finding new and gentler treatment options is a big focus for doctors and researchers.

One of the current treatments is a medicine called pembrolizumab. It's a type of immunotherapy, which helps your body's own immune system fight the cancer. Usually, this medicine is given through a needle into a vein in your arm, like a drip, which is called an intravenous (IV) infusion. This study is testing if an alternative way of giving the medicine, through a simple injection under the skin (called a subcutaneous or SC injection), works similarly.

The main idea behind this study is to compare how pembrolizumab acts in your body when given as an IV drip versus a skin injection. Researchers will look at things like how quickly the medicine gets into your system and how long it stays there with each method. This information helps them understand if the new injection method could be a good and convenient option for patients in the future.

Key takeaways

This study is for advanced non-small cell lung cancer.
It's comparing two ways to give the medicine pembrolizumab: IV drip vs. under-skin injection.
The aim is to understand how the new injection works in the body.
Participation involves regular clinic visits for treatment and tests.
You can stop participating at any time.
The study helps improve future lung cancer treatments.

Who may be eligible?

To be part of this study, you would generally need to have a confirmed diagnosis of non-small cell lung cancer that has spread to other parts of your body. Doctors would also need to see that your cancer can be measured, often through scans, so they can track how you respond to treatment.

There are also reasons why you might not be able to join. For example, if you have a different type of lung cancer called small cell lung cancer, you wouldn't be suitable for this specific study. Also, if you've already had other treatments for your metastatic non-small cell lung cancer, or if you have certain other serious health conditions like active autoimmune diseases or some types of lung problems, this study might not be right for you. They also can't include people with certain active infections or cancer that has spread to the brain and is causing problems.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have non-small cell lung cancer that has spread.
My cancer was recently diagnosed as metastatic.
I haven't had other treatments for my widespread lung cancer yet.
I do not have other serious active medical conditions, like some severe autoimmune diseases or certain lung problems.
My cancer can be seen and measured on scans.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you might receive pembrolizumab either through a drip into your arm or as an injection under your skin, depending on which group you are in. You would need to attend regular clinic visits for this treatment and to have various tests, such as blood tests and scans, to see how your body is reacting to the medicine and how your cancer is responding. The exact number of visits and tests will be explained in detail by the study team. You would be followed closely by the medical team throughout the study and potentially for some time after your treatment finishes to monitor your health.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be access to a new way of receiving treatment that might be more convenient, or the chance to help doctors learn more about better lung cancer care for everyone. However, like all medicines, pembrolizumab can have side effects, and the new injection method may have unique effects. The study team will explain all known potential side effects and risks to you in detail. You are always in control of your decision and can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (67)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Providence Medical Foundation ( Site 0117)
Verified postcode
Fullerton, United States
Illinois Cancer Care ( Site 0101)
Verified postcode
Peoria, United States
Montefiore Medical Center ( Site 0104)
Verified postcode
The Bronx, United States
University of Cincinnati Medical Center ( Site 0112)
Verified postcode
Cincinnati, United States
Beijing Peking Union Medical College Hospital ( Site 5000)
Verified postcode
Beijing, China
Chongqing University Three Gorges Hospital ( Site 5018)
Verified postcode
Chongqing, China
Fujian Province Cancer Hospital ( Site 5007)
Verified postcode
Fuzhou, China
The First Affiliated hospital of Xiamen University ( Site 5008)
Verified postcode
Xiamen, China
The first affiliated hospital, Sun Yat-Sen university ( Site 5011)
Verified postcode
Guangzhou, China
Southern Medical University Nanfang Hospital ( Site 5003)
Verified postcode
Guangzhou, China
Huizhou Central People's Hospital ( Site 5004)
Verified postcode
Huizhou, China
Jiangmen Center Hospital ( Site 5001)
Verified postcode
Jiangmen, China

Common questions

What is the main goal of this study?

The main goal is to compare two ways of giving the lung cancer medicine pembrolizumab: through a drip in your arm or as an injection under the skin.

What kind of lung cancer is this study for?

It's for people recently diagnosed with non-small cell lung cancer that has spread to other parts of the body.

What is pembrolizumab?

It's a type of immunotherapy medicine that helps your immune system fight cancer.

Will I definitely get the new injection?

You might get the injection or the usual drip; it depends on which group you are assigned to as part of the study.

Can I stop being part of the study if I change my mind?

Yes, you can leave the study at any time without it affecting your future medical care.