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Modified osimertinib dosing, with or without cobicistat as a pharmacokinetic booster, to improve cost-effectiveness of advanced Non-Small Cell Lung Cancer treatment - OSIBOOST 2

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505700-35-00
Enrollment
60
Registered
2024-01-25
Start date
2024-07-16
Completion date
Unknown
Last updated
2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer with an EGFR driver mutation.

Brief summary

OSIBOOST 2-A: The daily cumulative dose reduction accomplished in individual patients, while retaining osimertinib exposure (i.e. osimertinib trough (Cmin,SS) levels within the specified provisional therapeutic range (125 – 259 ng/mL)., OSIBOOST 2-B: CNS disease control rate (DCR) at 12 weeks.

Detailed description

Osimertinib and AZ5104 trough concentrations in plasma during steady state, Number of (Serious) Adverse Events and Suspected Unexpected Serious Adverse Reaction events during trial course and follow-up., OSIBOOST 2-A: Average osimertinib intake reduction over time., Progression-Free Survival (PFS) during osimertinib/cobicistat concomitant treatment., CYP3A genotype., OSIBOOST 2-B: Trough concentrations levels at steady state for osimertinib and AZ5104 in cerebrospinal fluid., OSIBOOST 2-B: ctDNA analysis of cerebrospinal fluid.

Interventions

DRUGTybost 150 mg film-coated tablets
DRUGTAGRISSO 80 mg film-coated tablets

Sponsors

University Hospital Maastricht
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
OSIBOOST 2-A: The daily cumulative dose reduction accomplished in individual patients, while retaining osimertinib exposure (i.e. osimertinib trough (Cmin,SS) levels within the specified provisional therapeutic range (125 – 259 ng/mL)., OSIBOOST 2-B: CNS disease control rate (DCR) at 12 weeks.—

Secondary

MeasureTime frame
Osimertinib and AZ5104 trough concentrations in plasma during steady state, Number of (Serious) Adverse Events and Suspected Unexpected Serious Adverse Reaction events during trial course and follow-up., OSIBOOST 2-A: Average osimertinib intake reduction over time., Progression-Free Survival (PFS) during osimertinib/cobicistat concomitant treatment., CYP3A genotype., OSIBOOST 2-B: Trough concentrations levels at steady state for osimertinib and AZ5104 in cerebrospinal fluid., OSIBOOST 2-B: ctDNA analysis of cerebrospinal fluid.—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026