Boosting osimertinib Blood Brain Barrier penetration in patients with epidermal growth factor receptor mutated non-small cell lung cancer (OSIBBBOOST)
This research, called OSIBBOOST, is investigating how well a lung cancer medication, osimertinib (also known as Tagrisso), gets into the brain and spinal fluid. This is important because lung cancer can sometimes spread to these areas. The study is for patients with a specific type of lung cancer (EGFR-mutated non-small cell lung cancer) who are already taking osimertinib and are responding well to it. Researchers want to find out if adding another commonly used drug, febuxostat (Adenuric), can help more of the osimertinib reach the brain and spinal fluid. They will measure the levels of osimertinib in blood and spinal fluid before and after patients start taking febuxostat to see if there's a difference. This is a Phase II study, meaning it's an early stage but focused on how the drugs work together.
At a glance
What is this study about?
When you have lung cancer, especially a type called EGFR-mutated non-small cell lung cancer, your doctor might prescribe a medication called osimertinib (Tagrisso). This drug works by targeting specific changes in the cancer cells. However, sometimes cancer can spread to the brain and spinal cord, and it can be tricky for some medications to reach these areas effectively due to a natural protective barrier called the blood-brain barrier.
This study, called OSIBBOOST, is looking into how well osimertinib gets past this barrier and into the brain and spinal fluid. The exciting part is that researchers want to see if adding another drug, febuxostat (Adenuric), might help more osimertinib reach these important areas. Febuxostat is a medication already used for other conditions, and doctors believe it might have a helpful effect when used with osimertinib.
The main goal of this research is to measure the amount of osimertinib in the blood and spinal fluid before and after patients start taking febuxostat. By doing this, they hope to understand if combining these two drugs could lead to better penetration of osimertinib into the brain and spinal cord, potentially making the treatment more effective for some patients.
Key takeaways
- The study aims to improve how a lung cancer drug (osimertinib) gets into the brain and spinal fluid.
- It involves adding another drug (febuxostat) to see if it helps.
- Participants are already taking osimertinib and responding well to it.
- Blood and spinal fluid samples will be taken to measure drug levels.
- This is an early-stage study (Phase II) looking at how the drugs work together.
Who may be eligible?
To be considered for this study, you need to have a specific type of lung cancer called EGFR-mutated non-small cell lung cancer. It's important that your cancer has *not* spread to your brain or spinal cord when you join the study, which will be checked with a special brain scan.
You must already be taking osimertinib (Tagrisso) as part of your regular treatment, and it should be working well for you. This means your cancer should be stable or improving. You also can't have a specific genetic marker (called ABCG2 34G>A SNP), which your doctors will check.
The study is open to both men and women, aged 18 or older. If you meet these general criteria, your doctor can then discuss with you whether this study might be a suitable option.
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 EGFR-mutated non-small cell lung cancer?
- Am I currently taking osimertinib (Tagrisso) and is it working well for me?
- Has my doctor confirmed that my cancer has not spread to my brain or spinal cord?
- Am I aged 18 or older?
- Have I been told I don't have the ABCG2 34G>A genetic marker?
What does participation involve?
If you decide to take part in this study, you will continue taking your regular osimertinib (Tagrisso) tablets. The main addition will be taking febuxostat (Adenuric) tablets for a period. Throughout the study, you will have specific appointments where doctors will take blood samples and also collect a small amount of spinal fluid (a procedure called a lumbar puncture) both before and after you start taking the febuxostat. These samples will be used to measure the levels of osimertinib and related substances. Doctors will also monitor you closely for any side effects. The total duration of your participation will be discussed in detail by the study team.
Potential risks and benefits
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Common questions
What is osimertinib (Tagrisso) used for?
Osimertinib is a medicine used to treat a specific type of lung cancer called EGFR-mutated non-small cell lung cancer.
What is febuxostat (Adenuric) and why is it part of the study?
Febuxostat is a medicine usually used for other conditions, but researchers think it might help mehr osimertinib reach the brain and spinal fluid, potentially improving treatment.
Will I have to stop my current cancer treatment?
No, you will continue taking your regular osimertinib (Tagrisso) medication as prescribed by your doctor.
What is a lumbar puncture and why is it needed?
A lumbar puncture is a procedure where a small amount of fluid is taken from around your spinal cord. It's needed to measure how much osimertinib is getting into your spinal fluid.
What happens if I experience side effects?
The study team will carefully monitor you for any side effects and provide appropriate care and advice if you experience any.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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