Active not recruitingPHASE2INTERVENTIONAL

Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC

This important study is looking into the best way to treat a type of lung cancer that has spread to the brain. Researchers want to compare two approaches: giving a drug called osimertinib by itself, or giving osimertinib alongside a special type of focused radiation called Stereotactic Radiosurgery (SRS). This study is for people who have stage IV non-small cell lung cancer with a particular genetic change called EGFR positive, and who haven't had previous treatment for their advanced cancer. The goal is to see if combining SRS with osimertinib is more effective than the drug alone, especially for controlling the cancer in the brain. It's a randomised study, meaning participants will be assigned to one of the treatment groups by chance.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

British Columbia Cancer Agency

Enrolment target

Start

19 Mar 2019

Estimated completion

01 Apr 2025

Lung Cancer Non-small Cell Stage IV Brain Metastases

What is this study about?

This study is designed for individuals in the UK who have a type of lung cancer called non-small cell lung cancer that has spread to their brain. This is known as Stage IV lung cancer with brain metastases. The researchers are particularly focusing on patients whose cancer has a specific genetic change, which doctors call an EGFR positive mutation. This mutation means the cancer cells have a particular switch that can be targeted by certain medicines.

The main aim of this study is to compare two ways of treating these brain metastases. One group of patients will receive a drug called osimertinib on its own. Osimertinib is a targeted therapy designed to block the signals that help EGFR positive cancer cells grow. The other group will receive osimertinib, but also have a special type of focused radiation treatment called Stereotactic Radiosurgery (SRS). SRS delivers a very precise, high dose of radiation to the brain tumours while trying to spare healthy brain tissue. Researchers want to see if adding SRS to osimertinib improves treatment outcomes more than taking osimertinib alone.

By comparing these two approaches, doctors hope to find out which method is more effective at controlling the cancer in the brain, improving patients' quality of life, and potentially helping them live longer. This information will help guide future treatment decisions for people with this specific type of lung cancer.

Key takeaways

Compares osimertinib alone vs. osimertinib with focused radiation (SRS) for lung cancer in the brain.
Specifically for non-small cell lung cancer with an EGFR positive genetic change.
Participants will be randomly assigned to one of the two treatment groups.
Involves taking osimertinib tablets and regular monitoring with scans and blood tests.
Aims to find the most effective treatment for this specific type of advanced lung cancer.

Who may be eligible?

This study is for adults aged 18 or older with non-small cell lung cancer that has spread to the brain. Your lung cancer needs to have a specific genetic change called an EGFR positive mutation (either exon 19 deletion or L858R mutation) and you shouldn't have had any main cancer treatments before this.

Important points for brain metastases are that they should be causing only mild symptoms, or no symptoms at all. Your MRI scans will be checked to confirm the size and number of these brain tumours meet specific criteria – generally, no more than 10 small tumours, and they need to be a safe distance from your optic nerve. You should also be generally well enough to take part, with a good overall health score (ECOG performance status 0-2), and expecting to live for more than 6 months.

However, you can't join if you've already been treated with osimertinib or similar drugs. Also, if your brain metastases are causing severe problems, require surgery right away, involve the lining of the brain (leptomeningeal disease), or if you've had radiation or surgery to your brain for these tumours before, you won't be able to participate. Having certain other medical conditions or a pacemaker that isn't safe for MRI scans might also prevent you from joining.

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.

Do I have non-small cell lung cancer that has spread to my brain?
Has my lung cancer been tested and confirmed as 'EGFR positive'?
Have I not had previous main treatments for my advanced lung cancer?
Are my brain tumours causing mild, or no, symptoms right now?
Am I generally well enough to participate in a clinical study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first undergo some checks to make sure the study is right for you. If you qualify, you'll be randomly assigned to one of two treatment groups: either you'll receive the drug osimertinib alone, or you'll receive osimertinib plus Stereotactic Radiosurgery (SRS) for your brain tumours. Being 'randomly assigned' means you'll be put into a group by chance, like flipping a coin.

Both groups will receive osimertinib tablets, which you take by mouth. The SRS treatment is a short course of high-precision radiation given over a few sessions. You will have regular hospital visits for check-ups, blood tests, and MRI scans to monitor your progress and how well the treatment is working. Doctors will also check for any side effects. The exact number of visits and the full duration of the study will be explained in detail by the study team, but it will involve ongoing monitoring as long as the treatment is beneficial and safe for you.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of accessing new treatments or combinations of treatments before they are widely available. You will also be closely monitored by a specialist medical team. However, like all medical treatments, both osimertinib and SRS have potential side effects and risks, which will be fully explained to you before you decide to participate. There's no guarantee that the treatment will be effective for you, and it might not be better than standard treatments. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

BC Cancer, Vancouver Centre
Verified postcode
Vancouver, Canada
Princess Margaret Hospital
Verified postcode
Toronto, Canada
Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada

Common questions

What is EGFR positive lung cancer?

It's a type of non-small cell lung cancer where the cells have a specific genetic change that helps them grow. Certain drugs, like osimertinib, are designed to target this change.

What is Stereotactic Radiosurgery (SRS)?

SRS is a very precise type of radiation therapy that delivers high doses of radiation to a small area, like a brain tumour, while trying to protect surrounding healthy tissue. It's not surgery in the traditional sense.

Will I know which treatment group I'm in?

Yes, this is an 'open-label' study, which means both you and your doctors will know whether you are receiving osimertinib alone or osimertinib with SRS.

What kind of side effects might I experience?

Osimertinib and SRS can have different side effects. The study team will explain all the known and potential side effects of each treatment so you can make an informed decision.

How long will I be in the study?

The duration of your participation will depend on how you respond to the treatment. You will continue as long as the treatment is helping you and you are tolerating it well, or until the end of the study.