RecruitingPhase 2

Boosting Osimertinib Blood Brain Barrier Penetration

Netherlands7 participantsStarted 2026-06

Plain-language summary

The goal of this proof-of-concept clinical study is to determine the effect of combining osimertinib with febuxostat on cerebrospinal fluid concentrations of osimertinib in patients with epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC). The main question it aims to answer is: what is the effect of combining osimertinib with the ABCG2 inhibitor febuxostat on cerebrospinal fluid to unbound plasma osimertinib concentration ratio in patients with EGFR mutated NSCLC without central nervous system (CNS) metastases and without the ABCG2 34G\>A single nucleotide polymorphism (SNP)?

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The patient has metastatic EGFR-mutated NSCLC and is treated with osimertinib as part of regular care with CT-confirmed stable disease or better. Patients with (signs of) disease progression, are also eligible if their treating physician deems the treatment to be appropriate beyond progression and the expected osimertinib treatment duration is at least 1 month.
. The patient has an European Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
. The patient is 18 years of age or older.
. The patient is able and willing to sign informed consent prior to any tests or procedures.
. The patient is able and willing to undergo additional blood sampling for e.g. therapeutic drug monitoring.
. The patient is able and willing to undergo lumbar punctions to obtain CSF.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effect of combining osimertinib with febuxostat on osimertinib CSF:plasma ratio in patients with EGFR NSCLC without CNS metastases

Timeframe: 22-25 days after start of combination osimertinib + febuxostat

Trial details

NCT IDNCT07485452

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

View on ClinicalTrials.gov More Non-Small Cell Lung Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The patient has metastatic EGFR-mutated NSCLC and is treated with osimertinib as part of regular care with CT-confirmed stable disease or better. Patients with (signs of) disease progression, are also eligible if their treating physician deems the treatment to be appropriate beyond progression and the expected osimertinib treatment duration is at least 1 month.
. The patient has an European Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
. The patient is 18 years of age or older.
. The patient is able and willing to sign informed consent prior to any tests or procedures.
. The patient is able and willing to undergo additional blood sampling for e.g. therapeutic drug monitoring.
. The patient is able and willing to undergo lumbar punctions to obtain CSF.

Boosting Osimertinib Blood Brain Barrier Penetration

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Boosting Osimertinib Blood Brain Barrier Penetration

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria