Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

C4221008 - A Phase 2, Open-label Study of Encorafenib + Binimetinib in Patients with BRAFV600-mutant Non-small Cell Lung Cancer

This research study, called C4221008, is exploring a combination of two medicines, encorafenib and binimetinib, for people with a common type of lung cancer called non-small cell lung cancer. Specifically, it's for patients whose cancer cells have a particular genetic change known as a BRAFV600 mutation. This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. The main goal is to find out how many patients experience the shrinking of their tumours while taking these drugs. This will be looked at in patients who haven't had treatment before, and also in those who have had previous treatments. The study aims to gather important information about how effective this combination treatment is.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Pfizer Inc.

Enrolment target

Start

02 Sep 2024

Non-small Cell Lung Cancer

What is this study about?

This clinical trial is looking into a new way to treat a type of lung cancer called non-small cell lung cancer. For some people with this cancer, their cancer cells have a specific genetic change or 'mutation' called BRAFV600. This study is testing a combination of two drugs, encorafenib and binimetinib, which are designed to target cells with this particular mutation.

The main purpose of the study is to see how many patients respond to this treatment. 'Response' means that the cancer shrinks or stops growing. Researchers will measure this carefully, both in patients who haven't had any treatment for their lung cancer yet, and in those who have tried other treatments already. They want to understand how effective these drugs are in different situations.

By taking part, you would be helping doctors learn more about how to treat this specific type of lung cancer. This information could help future patients. The drugs involved are Braftovi (encorafenib) and Mektovi (binimetinib), which are given as tablets or capsules.

Key takeaways

This study evaluates two drugs for BRAFV600-mutated non-small cell lung cancer.
It aims to see if the drugs shrink the cancer in new and previously treated patients.
You would take specific tablets or capsules as part of the treatment.
Regular check-ups and scans will monitor your health and treatment response.
Participation could help advance lung cancer treatment.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would need to be at least 18 years old. There's no upper age limit, meaning older adults can also take part. The study is open to both men and women.

The most important requirement is that you must have non-small cell lung cancer, and your cancer cells must have a specific genetic change called the BRAFV600 mutation. Your doctors would be able to check for this mutation with a test.

There might be other health requirements or previous treatments that could affect whether you can join, so your doctor will be able to discuss all the details with you. They will review your medical history to make sure the study is a good fit for you.

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 or older?
Do you have non-small cell lung cancer?
Has your cancer been tested and found to have a BRAFV600 gene mutation?
Are you able to take oral medications (tablets/capsules)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking the study medications, encorafenib and binimetinib, likely in tablet or capsule form. Since this is an 'open-label' study, you and your doctors will know which medicines you are receiving. You would have regular visits to the clinic for medical check-ups, blood tests, and scans to see how the treatment is working and monitor your health. These scans would help doctors measure if your cancer is shrinking or staying stable. The exact number of visits, tests, and the total length of time you'd be in the study would be explained in detail by the study team, as it can vary. There would also be follow-up appointments after you finish taking the study drugs.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available, and close medical monitoring. However, like all medications, the study drugs may have side effects, which could be mild or more serious. The study team will explain all known side effects. There's also no guarantee that the treatment will work for everyone. You have the right 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
Netherlands
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Unverified
Spain
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Unverified
Italy

Common questions

What is the BRAFV600 mutation?

It's a specific change in the genes of some cancer cells that can make them grow and spread. These drugs are designed to target this change.

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

It's the most common type of lung cancer. 'Non-small cell' refers to how the cancer cells look under a microscope.

What are encorafenib and binimetinib?

These are two separate medications that are being tested together. They are specifically designed to work against cancer cells with the BRAFV600 mutation.

Will I know if I'm getting the active treatment?

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

How long will I be on the study treatment?

The duration can vary for each patient, but the study team will explain the expected period during your initial discussions.