RecruitingOBSERVATIONAL

PEMBRO-K : Evaluation of Pembrolizumab Therapeutic Pharmacological Monitoring Benefit in NSCLC

This study is about a type of lung cancer called non-small cell lung cancer (NSCLC). We're trying to understand more about a treatment drug called pembrolizumab, which is already used to treat this cancer. Specifically, we want to see if the amount of the drug in a patient's blood is linked to how effective the treatment is and if they experience any side effects. Even though pembrolizumab has helped many people, it doesn't work for everyone, and some people have side effects. By studying this, we hope to find ways to make treatments better and more personalised in the future for people with lung cancer.

At a glance

Status

Recruiting

Sponsor

University Hospital, Angers

Enrolment target

Start

17 Dec 2025

Estimated completion

01 Jun 2028

Non Small Cell Lung Cancer

What is this study about?

Lung cancer is a serious health problem, and non-small cell lung cancer (NSCLC) is the most common type. Doctors are always looking for better ways to treat it. One important development has been new drugs that work with the body's immune system to fight cancer. These are called 'targeted therapies' because they focus on specific ways cancer cells grow or hide from the immune system.

Pembrolizumab is one of these new drugs that's already approved and used to treat NSCLC. It works by blocking a specific pathway (like a signal) called PD-1, which cancer cells sometimes use to switch off the immune system's attack. By blocking this, pembrolizumab helps your own immune system 'wake up' and fight the cancer more effectively.

Even though pembrolizumab has been very helpful for many people, we don't fully understand if the amount of the drug in a person's body is related to how well it works or if they experience side effects. This study aims to look at this more closely in people being treated for NSCLC. We want to see if there's a link between how much drug is in your system and your treatment results, which could help doctors give more personalised care in the future.

Key takeaways

The study focuses on an existing lung cancer drug, pembrolizumab.
It aims to understand drug levels in the body and their link to treatment success and side effects.
This research could help doctors personalise future lung cancer treatments.
Participants will have extra blood tests during their routine appointments.
You don't get a new drug; it's about better understanding current treatment.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have non-small cell lung cancer (NSCLC). You must also be receiving pembrolizumab treatment, either on its own or with other medicines, and have a special line (like a catheter) in place that allows doctors to give you infusions and take blood samples easily.

There are a few reasons why someone might not be able to join. For example, if you don't agree to take part, or if you are under special legal protection where you can't make your own decisions about joining studies, you wouldn't be able to participate. This is to make sure everyone who joins does so willingly and understands what's involved.

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.

Are you 18 years old or older?
Have you been diagnosed with non-small cell lung cancer (NSCLC)?
Are you currently receiving pembrolizumab treatment?
Do you have a medical line (like a catheter) in place for treatment?
Are you willing to provide extra blood samples?
Are you able to provide consent (agreement) to join the study?

Answer every question to see your result.

What does participation involve?

This study is designed to gather information from patients who are already receiving pembrolizumab as part of their standard care for non-small cell lung cancer. It means you wouldn't be given a new or experimental drug. Participating would likely involve providing some extra blood samples during your regular treatment visits. These samples would help researchers measure the level of pembrolizumab in your body. There would be no additional hospital visits specifically for the study beyond your usual treatment schedule. The total duration of your participation would depend on how long you are on pembrolizumab treatment, but the study team would explain the exact timeline to you. You would continue to receive all your normal scans and medical care as usual.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information we learn could help improve future treatments for people with lung cancer. The main risk involves having extra blood samples taken, which might cause minor discomfort, bruising, or a small infection at the needle site, similar to any blood test. You should know that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Angers University Hospital
Verified postcode
Angers, France· Recruiting
CH Le Mans
Verified postcode
Le Mans, France· Not yet recruiting

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer, making up about 85% of all lung cancer cases.

What is pembrolizumab?

It's a medicine that helps your own immune system fight cancer cells by blocking a specific pathway that cancer uses to hide.

Will I get a new drug if I join?

No, you will continue to receive pembrolizumab, which is already an approved treatment for your condition.

What will I have to do if I participate?

You'll have extra blood samples taken during your regular treatment appointments to measure drug levels.

Can I stop participating at any time?

Yes, you can leave the study whenever you want, and your medical care won't be affected.

How to find out more

Guillaume DREVIN, Doctor

guillaume.drevin@chu-angers.fr 0241354551 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.