OSIBOOST 2: Improving Osimertinib cost-effectiveness in Non-Small Cell Lung Cancer treatment using dose-modification and pharmacokinetic boosting with cobicistat
- Conditions
- on-Small Cell Lung Cancer with an EGFR driver mutation.Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2023-505700-35-00
- Lead Sponsor
- niversity Hospital Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method