RecruitingPhase 4NCT05748093

Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boosting With Cobicistat

Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boosting With Cobicistat (OSIBOOST 2)


Sponsor

Maastricht University Medical Center

Enrollment

60 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to assess the feasibility of pharmacokinetically boosting osimertinib using cobicistat in order to improve osimertinib exposure in individual patients with advanced NSCLC (Non-Small Cell Lung Cancer) with mutated EGFR (Epidermal Growth Factor Receptor). The main questions it aims to answer are: * Cohort 1: Does concurrent use of osimertinib and cobicistat allow for osimertinib weekly intake reductions? If so, how much can the intake be reduced while retaining clinically effective exposure? * Cohort 2: Does concurrent use of osimertinib and cobicistat allow for improved penetration of osimertinib in the central nervous system, in patients with CNS (central nervous system) oligoprogression? Participants who are taking osimertinib in regular care will receive cobicistat in addition to their other medication. They will undergo blood sampling to measure the amount of osimertinib in blood, and measure the effect of boosting. Additionally, in cohort 1 patients will be dose-reduced if their exposure levels allow.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called cobicistat (commonly used in HIV treatment) can boost blood levels of osimertinib — a lung cancer drug — making it more effective at a lower dose and potentially reducing treatment costs for patients with advanced non-small cell lung cancer (NSCLC). **You may be eligible if...** - You are 18 or older with advanced NSCLC that has a specific gene mutation called an EGFR mutation - Your doctor has already prescribed osimertinib 80 mg daily as your standard treatment - Your general health is adequate (WHO performance status ≤2) - You are willing to have blood drawn for drug level testing **You may NOT be eligible if...** - You have squamous cell NSCLC - You do not have an EGFR mutation in your cancer - Your cancer is rapidly progressing and you are not responding to current treatment - You are unable or unwilling to provide blood samples Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCobicistat

Feasibility of pharmacokinetic boosting using cobicistat for personalized treatment strategies for osimertinib.


Locations(1)

MaastrichtUMC

Maastricht, Limburg, Netherlands

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NCT05748093


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