Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti- PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients with Advanced or Metastatic Non-Small Cell Lung Cancer

This research study is looking at different ways to treat advanced non-small cell lung cancer. It’s comparing combinations of a drug called cemiplimab (which helps your immune system fight cancer) with standard chemotherapy drugs. The main goal is to find out if these new combinations help people live longer. Researchers will also check for side effects, how well the treatments shrink the cancer, and if they improve a person's quality of life. This is a large study (Phase 3), meaning it's comparing a new treatment against standard care to see if it's better.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Regeneron Pharmaceuticals Inc.

Enrolment target

117

Start

26 Sep 2024

Non-small Cell Lung Cancer

What is this study about?

This study is designed for people who have been diagnosed with advanced non-small cell lung cancer. This means the cancer has spread or is difficult to treat with local therapy. The researchers want to find the best first treatment for this type of cancer.

The study will look at combining a medicine called cemiplimab with standard chemotherapy drugs. Cemiplimab is a type of immunotherapy. This kind of drug works by helping your body's immune system recognise and fight cancer cells. The chemotherapy drugs are common treatments that kill fast-growing cancer cells.

The main aim of the study is to see if these new combinations of treatments help people live longer than current standard treatments. They will also be carefully checking how well the treatment shrinks the cancer, how long any improvements last, and importantly, what side effects people might experience. Furthermore, they will assess how these treatments affect your daily life and overall well-being (your quality of life).

Key takeaways

This study evaluates new combinations of immunotherapy and chemotherapy for advanced non-small cell lung cancer.
The main goal is to improve how long people live.
It's a Phase 3 study, comparing new treatments to standard care.
Researchers will also look at side effects and quality of life.
Participants must be at least 18 years old and have advanced non-small cell lung cancer that hasn't been treated yet.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. Both men and women are welcome to take part.

The study is specifically for people who have been diagnosed with non-small cell lung cancer that is advanced or has spread to other parts of the body. You would be considered if you haven't yet received treatment for this stage of your lung cancer.

There will be other detailed medical checks to make sure the study treatment is safe and appropriate for you, and that your health generally is suitable to participate.

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?
Is your lung cancer considered 'advanced' or has it spread?
Have you not yet started treatment specifically for your advanced lung cancer?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive one of the study treatments, which involves a combination of medicines given through a drip (infusion) into your vein. You will have regular visits to the hospital or clinic for these treatments, as well as for check-ups, blood tests, and scans. These visits will help the doctors monitor your health, how the treatment is working, and any side effects you might experience. The specific schedule and duration of your treatment will depend on which group you are in and how you respond. After your main treatment period, there will be follow-up appointments to monitor your long-term health and the effects of the treatment. The overall duration of your involvement could be several months to a few years, including the follow-up period.

Potential risks and benefits

Taking part in this study could offer the potential benefit of receiving a new, potentially more effective treatment for your lung cancer. However, there are no guarantees, and the treatment might not work for everyone. All medications have potential side effects, and the study treatments may cause unwanted effects, some of which could be serious. The research team will monitor you closely for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (4)

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

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Unverified
France
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Unverified
Poland
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Unverified
Ireland
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Unverified
Greece

Common questions

What is Non-Small Cell Lung Cancer?

It's the most common type of lung cancer. It's called 'non-small cell' because of the way the cells look under a microscope.

What does 'advanced' or 'metastatic' mean?

It means the cancer has either grown widely in the lung or has spread to other parts of the body.

What is cemiplimab?

Cemiplimab is an immunotherapy drug that helps your own immune system fight cancer cells.

What does a 'Phase 3' study mean?

It means this is a large study comparing a new treatment or combination of treatments with the current standard treatment to see if it's better.

Will I know which treatment I'm getting?

This is a 'randomized' study, meaning you will be assigned to a treatment group by chance, like flipping a coin. Sometimes, neither you nor your doctor will know which specific treatment you are receiving (this is called 'blinded').