Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Multicenter, Randomized, Double-blind Trial to Demonstrate Similar Efficacy, Safety, and Immunogenicity of FYB206 (Keytruda Biosimilar Candidate) in Comparison to Keytruda (Pembrolizumab) as an Add-on to Chemotherapy in Treatment-naïve Patients with Metastatic Non-squamous Non-small Cell Lung Cancer (LOTUS)

Doctors are conducting a study to compare a new potential lung cancer treatment, FYB206, with an established drug called Keytruda. Both medications are given alongside regular chemotherapy for patients who have recently been diagnosed with a specific kind of advanced lung cancer, known as non-squamous non-small cell lung cancer. The main goal is to see if FYB206 is as effective at shrinking or getting rid of the cancer as Keytruda, and if it has a similar safety profile. Researchers will also look at how patients feel and how their bodies react to the treatments over about nine months, and for up to a year, to understand the potential benefits and any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Formycon AG

Enrolment target

Start

26 Aug 2024

NSCLC

What is this study about?

Imagine you or someone you know has been diagnosed with a type of lung cancer called non-small cell lung cancer, which has spread to other parts of the body (this is called metastatic). Doctors are always working to find new and effective ways to treat this condition. This particular study is looking at a new medication, FYB206, which is very similar to an existing and widely used cancer drug called Keytruda (its scientific name is pembrolizumab).

The main idea behind this study is to see if FYB206 can work just as well as Keytruda. They will both be given in addition to standard chemotherapy treatments. Researchers will be carefully checking how well the cancer responds to the treatment – for example, if it shrinks or disappears completely – over about nine months. They will also be looking closely at how safe these treatments are, monitoring any possible side effects and how patients' bodies react.

This kind of study, called a Phase III trial, is a very important step in developing new medicines. If FYB206 proves to be as safe and effective as Keytruda, it could become another valuable treatment option for people with this type of lung cancer in the future. It's about finding more ways to help patients have better outcomes.

Key takeaways

This study compares a new drug (FYB206) to an established drug (Keytruda) for advanced lung cancer.
Both drugs are given with chemotherapy for people with a specific type of lung cancer.
The main aim is to see if the new drug works as well and is as safe as Keytruda.
Researchers will monitor cancer response and side effects over about 9 months to a year.
It's a 'double-blind' study, meaning you won't know which drug you're getting.

Who may be eligible?

To join this study, people need to be at least 18 years old. The study is open to both men and women.

Doctors will also check other things about your health and your specific cancer to make sure the study is a good fit for you. For example, they'll need to confirm that you have a specific type of advanced lung cancer called non-squamous non-small cell lung cancer, and that you haven't had treatment for it before.

There might be other health conditions or medications that would prevent you from taking part, to ensure everyone in the study is as safe as possible and the results are clear. Your doctor will be able to explain all the requirements in detail.

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 at least 18 years old?
Have you been diagnosed with non-squamous non-small cell lung cancer that has spread (metastatic)?
Have you not had previous treatment for your advanced lung cancer?
Are you able to receive chemotherapy?
Are you willing to visit the clinic regularly for treatments and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either FYB206 or Keytruda, along with your regular chemotherapy treatments. You wouldn't get to choose which one you receive, as this is decided randomly, like flipping a coin, to ensure a fair comparison. Both you and your study doctor wouldn't know which drug you are receiving, which helps make the results as unbiased as possible.

Your participation would involve regular visits to the clinic for your treatments, usually given through a drip (infusion). During these visits, the study team would perform various assessments. This includes regular checks of your health, blood tests, and scans to see how your cancer is responding. They would also ask about any side effects you might be experiencing. They'll also check things like your heart rate, breathing, oxygen levels, and other vital signs.

This monitoring would happen throughout your treatment, and for up to a year after you start. In total, the main part of the study where your cancer response is measured lasts about 9 months (40 weeks), but other assessments will continue for a year. You would have a study team to support you throughout your involvement.

Potential risks and benefits

Taking part in a clinical trial means you might be among the first to receive a new treatment that could potentially help your condition. While new treatments offer hope, there's also a chance they might not work for everyone, or could have side effects. You might experience side effects like those from standard chemotherapy, or other side effects specific to the study drugs. The research team will carefully monitor you for any changes in your health. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

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Unverified
Romania
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Unverified
Bulgaria
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Unverified
Poland

Common questions

What is non-squamous non-small cell lung cancer?

It's a common type of lung cancer that starts in the cells in the lining of the lungs. 'Non-squamous' refers to the specific kind of cells where the cancer begins.

What is chemotherapy?

Chemotherapy uses strong medicines to kill cancer cells or slow their growth inside the body.

What does 'add-on to chemotherapy' mean?

It means the study drug (FYB206 or Keytruda) will be given in addition to your standard chemotherapy treatment, not instead of it.

What does 'double-blind' mean in a study?

It means neither you nor your study doctor will know whether you are receiving the new drug (FYB206) or the existing drug (Keytruda). This helps make the study results fair.

What does a 'biosimilar' mean?

A biosimilar is a biological medicine that is very similar to an existing approved biological medicine (the 'reference' product), in this case, Keytruda.