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OSIBOOST 2: Improving Osimertinib cost-effectiveness in Non-Small Cell Lung Cancer treatment using dose-modification and pharmacokinetic boosting with cobicistat
EU CTIS ID: 2023-505700-35-00
What this study is testing
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).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
- 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).
- The patient is either pregnant or breastfeeding.
See the full eligibility criteria
- 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).
- 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.
- 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).
- The patient is either pregnant or breastfeeding.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.