Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

STRIDER: A phase II Study evaluaTing intRacranial effIcacy of JDQ443 in patiEnts with KRAS G12C+ NSCLC and bRain metastases

The STRIDER study is testing a new medication called JDQ443. It's for adults who have a specific kind of non-small cell lung cancer, known as KRAS G12C positive, which has also spread to their brain. The main goal is to see if JDQ443 can shrink or stop the growth of brain tumours. Researchers will also check how the drug affects the cancer in other parts of the body, how long people live without the cancer getting worse, and their overall quality of life. This is a Phase II study, meaning it's still an early stage, but it's focused on finding out how effective the drug is for this particular group of patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

University Hospital Maastricht

Enrolment target

Start

20 Nov 2023

patients with KRAS G12C+ non small cell lung cancer and brain metastases

What is this study about?

The STRIDER study is designed to investigate a new medication, JDQ443, for a particular group of people living with lung cancer. Specifically, it's for adults whose non-small cell lung cancer has a special genetic change in the KRAS gene (called G12C positive) and has also spread to their brain, forming secondary tumours (known as brain metastases).

The main purpose of this study is to measure how well JDQ443 works in the brain. Researchers will be looking to see if the drug can shrink these brain tumours or stop them from growing. They will use special brain scans and criteria to assess this. This is really important because treating cancer that has spread to the brain can be challenging, and new treatments are always needed to improve patient care.

Beyond just looking at the brain tumours, the study will also check other important things. This includes how long people live without their cancer getting worse (both in the brain and elsewhere in the body), how the drug affects the cancer in other parts of the body, and how it impacts patients' daily lives and well-being. Safety is also a key focus, to understand any side effects the new drug might have.

Key takeaways

This study is for adults with a specific type of lung cancer (KRAS G12C+ non-small cell lung cancer) that has spread to the brain.
It's testing a new drug called JDQ443.
The main goal is to see if the drug can shrink or control brain tumours and how it affects overall cancer growth.
Researchers will also look at quality of life and safety.
It's a Phase II study, meaning it's an early step in testing this new treatment.
Participation involves regular check-ups and monitoring.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. The study is open to both men and women.

Crucially, you would need to have been diagnosed with a specific type of lung cancer called non-small cell lung cancer. This cancer must also have a particular genetic marker known as KRAS G12C positive. Additionally, the cancer must have spread to your brain, meaning you have brain metastases.

There will be other detailed medical checks to make sure the study is safe and appropriate for you, and these will be discussed with you by the study team.

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 been tested and confirmed to be 'KRAS G12C positive'?
Has your lung cancer spread to your brain (brain metastases)?
Are you able to attend regular appointments for check-ups and scans?

Answer every question to see your result.

What does participation involve?

If you join the study, you would receive the study drug, JDQ443. You'd have regular appointments for check-ups, which might include physical exams, blood tests, and scans (like MRI or CT scans) to monitor your cancer and check for any side effects. You might also be asked to fill out questionnaires about how you're feeling and your quality of life. These visits would help the doctors understand how the treatment is working and ensure your safety. The total duration of your participation would depend on how your treatment is progressing and what the study team determines is best for you, with regular follow-up over time.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new, experimental drug that could help control your cancer, especially in the brain, before it's widely available. However, there are also potential risks, as the drug's full side effects are still being understood. You might experience side effects, some of which could be serious. The study team will monitor you closely for any issues, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is 'KRAS G12C positive' lung cancer?

It's a specific type of non-small cell lung cancer that has a particular genetic change, or 'mutation', in the KRAS gene. This change can make the cancer grow and spread.

What are 'brain metastases'?

These are secondary tumours that form when cancer cells from your lung travel to your brain and start to grow there.

What is a 'Phase II' study?

This means it's an early-stage study designed to see if a new drug is effective for a specific condition and to understand its side effects. It usually involves a relatively small group of patients.

Will I know if I'm getting the drug or a placebo?

In this specific study, everyone enrolled will receive the new drug, JDQ443. There is no placebo group.

How will the doctors know if the drug is working?

Doctors will use regular brain scans (like MRI) to measure the size of your brain tumours and see if they are shrinking or staying the same. They'll also monitor your other cancer sites.