Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase 2, Open-Label Study in Subjects with Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

This research study, called a Phase 2 trial, is looking into a new treatment called Telisotuzumab Vedotin. It's for adults in the UK who have a particular kind of lung cancer (called 'non-small cell lung cancer') that has spread or is advanced, and hasn't had treatment yet. This specific type of cancer has a feature called a 'MET amplification', which means certain cells are overactive. The main goal is to find out how many patients respond to the medicine, meaning their tumours shrink. Researchers will also look at how long the treatment works, how it affects symptoms like cough and pain, and overall quality of life. This is an 'open-label' study, which means both patients and doctors will know which treatment is being given.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Abbvie Deutschland GmbH & Co. KG

Enrolment target

Start

01 Feb 2023

Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

What is this study about?

This study is a Phase 2 clinical trial that focuses on a new potential treatment for a specific type of lung cancer. The cancer involved is called 'non-small cell lung cancer' (NSCLC), which is the most common type. Specifically, it's for people whose NSCLC hasn't been treated before, is either advanced (meaning it has grown significantly) or has spread to other parts of the body (called metastatic), and is 'non-squamous' (referring to a type of cell in the lung). Crucially, this study is for individuals whose cancer has a particular genetic change known as 'MET amplification'. This means there's an overactivity in a protein that can make cancer grow and spread, and the new medicine, Telisotuzumab Vedotin, is designed to target this specific feature.

The main purpose of this research is to see how effectively the new medicine, Telisotuzumab Vedotin, can shrink tumours in patients with this specific form of lung cancer. This is measured by something called the 'objective response rate'. An independent group of experts will carefully review scans and other information to confirm these responses. Beyond just shrinking tumours, the researchers also want to understand other important things, like how long the treatment keeps the cancer from growing (called 'progression-free survival'), how long people live overall, and crucially, how it impacts their quality of life. This includes looking at symptoms like cough, pain, and how well people can perform daily activities.

This study is important because it's exploring a new way to treat a type of lung cancer that currently has limited options. By understanding how well Telisotuzumab Vedotin works and how it affects patients' lives, doctors can learn if this could become a valuable new treatment in the future. It's a key step in helping to improve care for people living with advanced lung cancer that has this specific genetic change.

Key takeaways

This study is testing a new medicine for a specific type of previously untreated advanced lung cancer.
It targets a cancer feature called 'MET amplification'.
Researchers want to see if the medicine shrinks tumours and improves quality of life.
You would receive the new medicine, and both you and your doctor would know this.
Participation involves regular visits for checks, tests, and to monitor your well-being.

Who may be eligible?

To join this study, people need to meet certain requirements. First, you must be 18 years old or older. The study is open to both men and women.

The main health requirements are that you have been diagnosed with a specific type of lung cancer called 'non-small cell lung cancer'. This cancer must be advanced, meaning it has grown significantly, or metastatic, meaning it has spread to other parts of your body. Your cancer also needs to be 'non-squamous', which refers to the cell type.

Most importantly, your cancer must have a specific genetic change called 'MET amplification', which doctors can often test for. Also, you must not have received any previous treatment for your advanced or metastatic lung cancer. Other detailed medical criteria, such as your general health, how well your organs are working, and whether you have other serious medical conditions, will also be checked by the study doctor to make sure it's safe for you 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 that is advanced or has spread?
Has your cancer been tested and found to have 'MET amplification'?
Have you NOT received any previous treatment for your advanced or spread lung cancer?
Are you generally well enough to take part in a clinical trial, as assessed by a doctor?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive the new medicine, Telisotuzumab Vedotin. This is an 'open-label' study, which means both you and your doctors will know that you are receiving the study drug. You will have regular visits to the clinic for medical check-ups, blood tests, and scans (like CT scans) to see how the treatment is working and to monitor your health. You will also be asked to complete questionnaires about your symptoms and how you are feeling, which helps researchers understand your quality of life during the study.

The exact number and frequency of visits will be explained in detail by the study team, but they will be more frequent initially and then might become less frequent over time. You will continue to receive the study medication for as long as it is benefiting you and you are tolerating it well. After you stop taking the study medication, there will be follow-up appointments to track your long-term health. The total duration of your participation will vary, but usually, these types of studies involve months or even years of follow-up.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment that is not yet widely available, which could potentially shrink your tumours or improve your symptoms. However, there are also potential risks involved. The new medicine, like all medications, can have side effects, which could range from mild to serious. The study team will explain all known side effects and monitor you very closely for any issues. It's important to remember that these are new treatments, and their full effects are still being understood. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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
Germany
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Unverified
Italy
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Unverified
France
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Unverified
Spain

Common questions

What does 'MET amplified' mean?

It means your lung cancer cells have too much of a specific protein, which can make the cancer grow and spread. This study's medicine is designed to target this feature.

What is 'Non-Small Cell Lung Cancer'?

It's the most common type of lung cancer. This study is for a specific kind of non-small cell lung cancer that hasn't received treatment yet and has spread.

What is a 'Phase 2' study?

Phase 2 studies are designed to see if a new treatment works and is reasonably safe in a larger group of people, after earlier smaller studies.

Will I know if I'm getting the new medicine?

Yes, this is an 'open-label' study, which means both you and your doctors will know you are receiving Telisotuzumab Vedotin.

How long would I be in the study?

The time you spend in the study can vary. You would receive the medicine as long as it's helping you and your body can tolerate it, followed by follow-up appointments.