Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A randomized, open-label, controlled phase III trial comparing the pembrolizumab platinum based chemotherapy combination with pembrolizumab monotherapy in first line treatment of non small-cell lung cancer (NSCLC) patients with PD L1 expression ≥50% on tumor cells : PERSEE TRIAL

This study, called PERSEE, is for people with a type of lung cancer called non-small cell lung cancer (NSCLC). Doctors are comparing two different ways of using a medicine called pembrolizumab as a first treatment. One group will receive pembrolizumab alongside standard chemotherapy (a combination treatment), while another group will receive pembrolizumab on its own. This trial focuses on patients whose cancer cells show a certain marker called PD-L1 at a high level (50% or more). By comparing these two treatments, researchers hope to find out which one is more effective and can offer a better outcome for patients with this specific type of lung cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Regional Et Universitaire De Brest

Enrolment target

349

Start

07 Nov 2024

non-small-cell lung cancer

What is this study about?

This important study, known as the PERSEE trial, focuses on a type of lung cancer called non-small cell lung cancer (NSCLC). This is the most common kind of lung cancer. When you're diagnosed with cancer, doctors often look for specific features. In this study, they are particularly interested in patients whose cancer cells have a high level of something called PD-L1 (over 50%). Think of PD-L1 as a flag on the cancer cell that helps it hide from the body's immune system.

The main aim of this trial is to see which treatment works better as a first step for these patients. 'First line treatment' means it's the initial therapy given after diagnosis. The study is comparing two different approaches using a medicine called pembrolizumab. Pembrolizumab is an immunotherapy medicine, which means it helps your own immune system fight the cancer. One group of patients will receive pembrolizumab together with traditional chemotherapy. The other group will receive pembrolizumab on its own, without chemotherapy.

By carefully comparing these two treatment plans, the researchers hope to understand which approach provides the most benefit. This could mean helping people live longer, improving their quality of life, or reducing side effects. Finding the most effective treatment for people with this specific type of lung cancer could lead to new standard treatments in the future.

Key takeaways

This study compares two ways to treat specific non-small cell lung cancer.
It's for people whose cancer cells show high levels of a marker called PD-L1.
One group gets immunotherapy (pembrolizumab) with chemotherapy, the other gets immunotherapy alone.
It's a 'Phase III' trial, meaning it's a advanced study to confirm if a new treatment is better.
Your participation could help improve future treatments for lung cancer.

Who may be eligible?

To join this study, you would generally need to be at least 18 years old. Both men and women are welcome to participate. The study is specifically for people who have been diagnosed with a type of lung cancer called non-small cell lung cancer.

Crucially, your cancer cells must show a high level of a specific marker called PD-L1, which means 50% or more of your cancer cells have this marker present. This is something your doctor can test for with a biopsy. You also need to be starting your very first treatment for this lung cancer; it's not for those who have already received other treatments.

There might be other health requirements needed to make sure the treatment is safe for you. Your doctor or the study team will be able to explain all the detailed criteria and check if you meet them.

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?
Has your doctor confirmed your cancer cells have a high level (50% or more) of the PD-L1 marker?
Are you about to start your first treatment for this lung cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have several health checks, like blood tests, scans, and a review of your medical history, to make sure it's safe for you to join. Once enrolled, you will be assigned to one of two groups: either receiving pembrolizumab and chemotherapy, or pembrolizumab on its own. You won't get to choose which group you're in, as this is decided randomly, like flipping a coin, to ensure the comparison is fair.

The treatments will involve regular visits to the hospital for infusions (medicine given through a drip into your arm). The exact number and frequency of visits will depend on your specific treatment plan, but you can expect them to be regular for several months. During these visits, there will be assessments, blood tests, and scans to monitor how you're responding to the treatment and to check for any side effects.

After your main treatment period, you will have follow-up visits, which might be less frequent, to continue monitoring your health over a longer period. The total time you'd be involved in the study, including treatment and follow-up, can vary, and the study team will provide you with a clearer timeline.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. On the benefit side, you would receive close medical monitoring and access to a new treatment approach that may be more effective for your type of lung cancer than current options. It also helps advance medical knowledge, potentially benefiting future patients. However, there are potential risks, as with any medical treatment. The medicines might cause side effects, which can vary from mild to severe, and may include fatigue, skin rashes, or changes in how your organs function. Not every treatment works for everyone, and there's no guarantee of benefit. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is non-small cell lung cancer (NSCLC)?

It's the most common type of lung cancer. This study focuses on a specific group of NSCLC patients.

What is PD-L1 and why is it important?

PD-L1 is a marker on cancer cells. If your cancer has a lot of it (50% or more), it suggests certain treatments might work well by helping your immune system fight the cancer.

What is pembrolizumab?

It's an immunotherapy medicine that helps your body's own immune system find and attack cancer cells.

Will I get to choose my treatment?

No, you'll be randomly assigned to one of the two treatment groups. This helps researchers compare the treatments fairly.

How long will I be in the study?

The total time, including treatment and follow-up, can vary. The study team will give you more specific details based on the treatment plan.