Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A study to compare efficacy, safety, and immune response of GME751 and EU-authorized Keytruda in adult participants with untreated metastatic lung cancer

Doctors are conducting an important study to find better ways to treat a type of advanced lung cancer called non-small cell lung cancer. This study is testing a new medicine, GME751, against a well-known cancer drug, Keytruda, to see how well it works and if it's safe. Keytruda is already approved in Europe, but GME751 is still being investigated. The study will look at whether GME751 can shrink tumours, how it affects the body's immune system, and if it causes any unwanted side effects. It’s open to adults aged 18 and over who have this type of lung cancer and haven't had treatment for it yet. This kind of research is vital for developing new treatments that could help people living with cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

H e x a l AG

Enrolment target

Start

19 Apr 2024

Non-small-cell lung cancer

What is this study about?

This study is about finding new and better ways to treat a specific kind of lung cancer called non-small cell lung cancer. This is the most common type of lung cancer, and in this study, doctors are focusing on people whose cancer has spread to other parts of the body (this is called 'metastatic') and who haven't had any treatment for it yet.

The main goal of this research is to compare a new medicine, called GME751, with a medicine that's already approved and commonly used in Europe, called Keytruda. Keytruda is known to work by helping your body's own immune system fight cancer cells. The doctors want to see if GME751 works just as well, or even better, than Keytruda, and if it's safe for people to take. They will also be looking at how GME751 affects the body's immune system.

Studies like this, called 'Phase III' studies, are a really important step in developing new medicines. They help doctors understand if a new treatment is effective and safe enough to be made available to more people in the future. By participating, you could help researchers learn valuable information that could lead to improved treatments for people with lung cancer.

Key takeaways

Tests a new medicine (GME751) against a standard treatment (Keytruda) for advanced lung cancer.
For adults with non-small cell lung cancer that has spread and not yet been treated.
Aims to check safety, effectiveness, and how the immune system responds.
Participation involves regular hospital visits, medicines, and check-ups.
You can withdraw at any time without affecting your usual care.
Your involvement could help develop new lung cancer treatments.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. There is no upper age limit, meaning older adults are welcome to take part too. Both men and women can join the study.

Crucially, you must have been diagnosed with non-small cell lung cancer, and it needs to be in an advanced stage where it has spread. Also, you must not have received any treatment for this advanced lung cancer yet. This means the study is looking for people who are starting their first treatment for their metastatic lung cancer.

There might be other health requirements or specific details about your cancer that doctors will check to make sure the study is right for you and safe. These checks are standard practice in clinical trials.

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?
Do you have non-small cell lung cancer?
Has your lung cancer spread (metastatic)?
Have you *not* had any treatment for your advanced lung cancer yet?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to either receive the new medicine, GME751, or the standard medicine, Keytruda. This choice is usually made at random, like flipping a coin. You won't know which treatment you're getting, and neither will your doctor, unless it's medically necessary. This helps researchers compare the treatments fairly.

You'll have regular hospital visits, where doctors and nurses will check your health, give you the study medication, and take samples like blood tests. They'll also perform scans to see how your cancer is responding to the treatment. These visits are important for monitoring your safety and how well the treatment is working.

The treatment period will last for a certain amount of time, and even after you stop taking the study medicine, there will be follow-up appointments. These follow-ups are important to track your long-term health and any ongoing effects of the treatment. The total duration of your involvement, from starting treatment to the final follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available and contributing to medical knowledge that could help others. However, there are also potential risks. The new medicine, GME751, might have side effects that aren't fully known yet, and even Keytruda has known side effects, some of which can be serious. Your doctors will discuss all known potential risks in detail before you decide to join. It's really important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual 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
Spain
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Unverified
Romania
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Unverified
Germany

Common questions

What type of lung cancer is this study for?

This study is for a common type of advanced lung cancer called non-small cell lung cancer that has spread and hasn't been treated yet.

What medicines are being studied?

The study is comparing a new medicine called GME751 with an existing cancer drug called Keytruda.

Can I choose which medicine I receive?

No, you won't be able to choose. You'll be randomly assigned to receive either GME751 or Keytruda, similar to drawing straws.

How old do I need to be to join?

You need to be 18 years old or older. There is no upper age limit.

What happens if I want to stop participating?

You can leave the study at any time, for any reason, and your regular medical care will not be affected.