NCT05748093RecruitingPhase 2
OSIBOOST 2: Improving Osimertinib cost-effectiveness in Non-Small Cell Lung Cancer treatment using dose-modification and pharmacokinetic boosting with cobicistat or ritonavir
Modified osimertinib dosing, with or without cobicistat (or ritonavir) as a pharmacokinetic booster, to improve cost-effectiveness of advanced Non-Small Cell Lung Cancer treatment - OSIBOOST 2
Source: EU CTIS (euclinicaltrials.eu) · Last updated 2 Nov 2026
Brief summary (registry, in English)
This study will consist of two sub-studies in patients with advanced EGFR mutated NSCLC. Depending on disease status, patients may be enrolled in sub-study A (stable disease or better) or B (CNS oligoprogression): OSIBOOST 2-A: is a single-arm near-equivalence study, intended to assess the clinical feasibility of a modified osimertinib dosing strategy combining therapeutic drug monitoring, osimertinib dose-modification and pharmacokinetic (PK) boosting, in order to improve osimertinib cost-effectiveness and reduce toxicity while maintaining clinical efficacy. This study will include patients with advanced EGFR positive NSCLC who are treated with osimertinib as part of regular care. The primary objective is to evaluate the clinical feasibility of a modified osimertinib dosing strategy to allow for a personalized, more cost-effective osimertinib dosing schedule while maintaining osimertinib exposure within the provisional, clinically-proven, therapeutic window (125 – 259 ng/mL). OSIBOOST 2-B: is an exploratory single-arm pharmacokinetic boosting study, designed to assess whether PK boosting provides a viable therapeutic option in patients with asymptomatic central nervous system (CNS) oligoprogression. The primary objective is to assess whether boosting standard (unaltered) osimertinib treatment can result in renewed CNS disease control, as a cost-effective alternative for off-label, non-reimbursable, dose-escalation to 160 mg osimertinib once daily (QD).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- First submitted
- 20 Oct 2023
- Start date
- 16 Jul 2024
- Lead sponsor
- University Hospital Maastricht
- Diseases
- Lung cancer
- NCT number
- NCT05748093
- EU CT number
- 2023-505700-35-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 51
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient is taking any other drug or herbal substance which 1) is known to strongly inhibit CYP3A, P-gp or BCRP activity; 2) is primarily metabolized by CYP3A, P-gp or BCRP and has a small therapeutic range; or 3) may otherwise affect CYP3A, P-gp or BCRP metabolic activity.
Other illness
- The patient has impaired gastrointestinal function that may alter the absorption of osimertinib or cobicistat (e.g. ulcerative disease, uncontrolled nausea or vomiting, malabsorption syndrome, small bowel resection).
- The patient has chronic liver disease (Child-Pugh score: class C).
Other
- The patient is either pregnant or breastfeeding.
Who the study is looking for
- The patient receives osimertinib 80 mg once daily as part of their standard treatment plan.
- The patient has a World Health Organisation (WHO) Performance Status (PS) of 0-2.
- 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 additional blood sampling (e.g. for therapeutic drug monitoring).
- The patient consents to their blood being analysed for CYP3A-genotype.
- OSIBOOST 2-A: 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 treatment beyond progression to be appropriate.
- OSIBOOST 2-B: the patient has non-squamous EGFR-mutated NSCLC with radiologically confirmed (RANO-progressive) asymptomatic intracranial progression, not in an eloquent area. Furthermore, extracranial disease should be controlled (no RECIST v1.1 progression).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Zuyderland Medisch Centrum Stichting Coordinator of this site? Confirm its status | Geleen | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| University Hospital Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.