RecruitingOBSERVATIONAL

An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe

This study is for adults with advanced non-small cell lung cancer who are already receiving a medicine called cemiplimab (Libtayo®) as part of their regular care. The main goal is to observe how well this treatment works and if it's safe when used in typical hospitals and clinics across Europe. It’s an observational study, meaning doctors won’t change your treatment, but will simply collect information about your progress. This helps us understand the real-world experience of patients on cemiplimab, tracking benefits and any side effects over time. The study will follow patients for several years to get a full picture.

At a glance

Status

Recruiting

Sponsor

Regeneron Pharmaceuticals

Enrolment target

500

Start

26 Oct 2022

Estimated completion

30 Oct 2028

Non-small Cell Lung Cancer

What is this study about?

This study is designed to learn more about a specific medication called cemiplimab, also known by its brand name Libtayo®. It's for adult patients who have a type of cancer called non-small cell lung cancer (NSCLC) that is considered advanced. The important thing to know is that this study isn't testing whether cemiplimab works; it's already approved for use. Instead, it's observing how well it works and if it's safe when used in the routine, day-to-day healthcare settings across Europe.

Think of it like this: when a new medicine is first approved, it's often tested in very controlled clinical trials. This study, however, wants to see what happens when the medicine is used in the 'real world' by many different doctors and patients. Researchers will collect information about people who are already being treated with cemiplimab for their lung cancer. This information will help them understand the actual benefits and any side effects people experience outside of the very strict conditions of earlier trials.

By gathering this real-world information, doctors and researchers can get a clearer picture of how cemiplimab performs for a wider range of patients and in standard medical practice. This kind of study helps improve our understanding of treatments and can inform future patient care decisions. It's about seeing the medicine in action, not changing how doctors typically treat their patients.

Key takeaways

Study is for adults with advanced non-small cell lung cancer on cemiplimab.
It observes how cemiplimab works in everyday clinical practice.
Your treatment won't change; you'll follow your doctor's plan.
Information is collected during routine clinic visits.
Participation helps improve understanding of cemiplimab for future patients.
You can leave the study at any time without affecting your care.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with non-small cell lung cancer. A key requirement is that your doctor has already decided that treatment with cemiplimab, possibly combined with platinum-based chemotherapy, is the right choice for you as part of your standard care. You must also be able to understand and complete some questionnaires related to the study and provide your written permission to take part.

There are also some reasons why you might not be able to join. For example, if you've already had cemiplimab treatment before the study starts, or if you have certain serious auto-immune conditions that are not well controlled. You also can't be in another study that's looking into a new or experimental drug. Your doctor will check if cemiplimab is suitable for you based on its official guidance, and if there are any other health issues that might make it difficult for you to take part.

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 decided that cemiplimab is part of your planned treatment?
Are you able to fill out questionnaires and give written consent?
Have you NOT received cemiplimab before your doctor decided on it for this course of treatment?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your treatment with cemiplimab will continue as usual, prescribed by your doctor. The study itself won't change your treatment plan. Instead, it involves collecting information during your routine check-ups. You'll likely visit your clinic about every three months while you're taking cemiplimab. After you stop cemiplimab treatment, you'll continue to be followed, with visits roughly every six months, for up to two years. Researchers will gather information from your medical records and you might be asked to complete some questionnaires during these visits.

The study aims to follow patients from when they start cemiplimab until they pass away, are no longer able to be contacted, decide to leave the study, or until the study finishes, which could be up to six years after it began. The total time you might be included in the study depends on your individual treatment journey and how long the main study runs.

Potential risks and benefits

The main benefit of taking part in this study is contributing to a better understanding of how cemiplimab works in real-world patients. This can help other people with similar conditions in the future by providing valuable information about the treatment's effectiveness and safety outside of strict clinical trial settings. Since this is an observational study, you will be receiving treatment that your doctor has already decided is best for you, so there are no new medical treatments given specifically for the study. The main risks are largely related to the time commitment for visits and completing questionnaires, and any potential for discomfort or anxiety related to discussing your health. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (49)

Klinikum Klagenfurt
Verified postcode
Klagenfurt, Austria· Recruiting
Salzburger Landeskliniken (SALK)
Verified postcode
Salzburg, Austria· Recruiting
Le Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Emile Muller Hospital
Verified postcode
Mulhouse, France· Recruiting
APHM - Hopital Nord
Verified postcode
Marseille, France· Recruiting
Centre Hospitalier Universitaire (CHU) de Poitiers
Verified postcode
Poitiers, France· Recruiting
Sainte Catherine Institut du Cancer Avignon Provence
Verified postcode
Avignon, France· Recruiting
Centre Hospitalier Universitaire Angers
Verified postcode
Angers, France· Recruiting
Center Hospitalier Universitaire (CHU) of Clermont
Verified postcode
Clermont-Ferrand, France· Recruiting
Centre Hospitalier - Le mans
Verified postcode
Le Mans, France· Recruiting
Hopital Tenon
Verified postcode
Paris, France· Recruiting
Hopitaux Universitaires de Strasbourg
Verified postcode
Strasbourg, France· Recruiting
Klinikum Konstanz
Verified postcode
Konstanz, Germany· Recruiting

Common questions

What does 'non-small cell lung cancer' mean?

It's the most common type of lung cancer, and there are different ways to treat it depending on its specific type and how advanced it is.

What is cemiplimab (Libtayo®)?

Cemiplimab is a type of cancer medicine called an immunotherapy that helps your body’s immune system fight cancer cells.

Will my treatment change if I join this study?

No, your treatment with cemiplimab will continue exactly as your doctor has already planned. The study only observes what happens.

How long will I be involved in the study?

You'll be followed from when you start cemiplimab treatment, with regular check-ups, and potentially for up to two years after you stop the medicine, or until the study ends (up to six years total).

What does an 'observational study' mean?

It means researchers are simply watching and collecting information about treatment that's already happening, rather than giving you new or experimental treatments.

How to find out more

Clinical Trials Administrator

clinicaltrials@regeneron.com 844-734-6643 Official trial record

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