NCT05748093 Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boosting With Cobicistat
| NCT ID | NCT05748093 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Maastricht University Medical Center |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2024-04-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: In order to be eligible to participate in this cohort 1, a subject must meet all of the following criteria: * The patient is set to receive osimertinib 80 mg QD as part of their standard treatment plan * The patient has a World Health Organization (WHO) Performance Status (PS) of ≤2. * The patient is 18 years or older * The patient is able and willing to sign informed consent * The patient is able and willing to undergo blood sampling * The patient has non-squamous advanced EGFR-mutated NSCLC with no signs of imminent progression (CT confirmed). If the patient does have signs of progression, they are only eligible if their treating physician deems the treatment to be appropriate beyond progression. * The patient consents to their blood being analysed for CYP3A-genotype In order to be eligible to participate in this cohort 2, a subject must meet all of the following criteria: * The patient is set to receive osimertinib 80 mg QD as part of their standard treatment plan * The patient has a World Health Organization (WHO) Performance Status (PS) of ≤2. * The patient is 18 years or older * The patient is able and willing to sign informed consent * The patient is able and willing to undergo blood sampling * The patient has non-squamous EGFR-mutated NSCLC with radiologically confirmed progressive (RECIST v1.1), but asymptomatic intracranial metastasis, not in an eloquent area (to be discussed with neurologist). Furthermore, the disease is controlled extracranially (no RECIST v1.1 progression). Exclusion Criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: * The patient does not take any other drug which is known to strongly inhibit CYP3A4/CYP3A5 activity * The patient does not take any other drug which is metabolized by CYP3A4/CYP3A5 and which has a small therapeutic window * The patient does not take any drug or product which may otherwise affect CYP3A4/CYP3A5 metabolic activity * The patient does not have impaired gastrointestinal function * The patient is neither pregnant nor breastfeeding * The patient does not have any contra-indication for cobicistat prescription, as listed in the summary of product characteristics for cobicistat
Contact & Investigator
Lizza Hendriks, MD, PhD
PRINCIPAL INVESTIGATOR
Maastricht University Medical Centre+
Frequently Asked Questions
Who can join the NCT05748093 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05748093 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05748093 currently recruiting?
Yes, NCT05748093 is actively recruiting participants. Contact the research team at paul.kruithof@mumc.nl for enrollment information.
Where is the NCT05748093 trial being conducted?
This trial is being conducted at Maastricht, Netherlands.
Who is sponsoring the NCT05748093 clinical trial?
NCT05748093 is sponsored by Maastricht University Medical Center. The principal investigator is Lizza Hendriks, MD, PhD at Maastricht University Medical Centre+. The trial plans to enroll 60 participants.
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