Skip to content

Boosting osimertinib Blood Brain Barrier penetration in patients with epidermal growth factor receptor mutated non-small cell lung cancer (OSIBBBOOST)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523033-26-00
Enrollment
14
Registered
2026-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with EGFR-mutated metastatic NSCLC, treated with osimertinib as part of regular care are eligible for inclusion. Participants have at least radiologically proven stable disease (SD) or better on regular care osimertinib therapy., without CNS metastases on brain MRI and without the ABCG2 34G>A SNP

Brief summary

Osimertinib concentration in CSF and plasma before and after combination with febuxostat

Detailed description

Osimertinib concentration in CSF before and after combination with febuxostat, Osimertinib plasma trough concentration before and after addition of febuxostat, AZ5104 and AZ7550 plasma trough concentration before and after combination with febuxostat, AZ5104 and AZ7550 CSF concentration before and after combination with febuxostat, Adverse events according to CTCAE v5.0 criteria, ABCB1 and ABCG2 genotype status, and osimertinib, AZ5104 and AZ7550 CNS concentrations, AEs and osimertinib, AZ5104 and AZ7550 concentrations in blood and CSF

Interventions

DRUGTAGRISSO 80 mg film-coated tablets
DRUGADENURIC 80 mg film-coated tablets

Sponsors

Academisch Ziekenhuis Maastricht
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Osimertinib concentration in CSF and plasma before and after combination with febuxostat

Secondary

MeasureTime frame
Osimertinib concentration in CSF before and after combination with febuxostat, Osimertinib plasma trough concentration before and after addition of febuxostat, AZ5104 and AZ7550 plasma trough concentration before and after combination with febuxostat, AZ5104 and AZ7550 CSF concentration before and after combination with febuxostat, Adverse events according to CTCAE v5.0 criteria, ABCB1 and ABCG2 genotype status, and osimertinib, AZ5104 and AZ7550 CNS concentrations, AEs and osimertinib, AZ5104 and AZ7550 concentrations in blood and CSF

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 20, 2026