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OSIBOOST 2NCT05748093

Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boosting With Cobicistat

StatusRecruiting
PhasePhase 4
Primary completion (estimated)

At risk: Primary completion moved 1 year 1 month later.

See at-risk trials from Maastricht University Medical Center

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Record History

All 6 versions: 5 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 1, 2026 to Jul 1, 2027 Show 6 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Trial status changed: Unknown → Recruiting
    • Study completion pushed from Sep 1, 2026 to Sep 1, 2027
    • Secondary endpoints: details revised at 2 of 6 entries
    • Collaborators expanded, about 14 words
    • Publications: details revised at 2 of 2 entries
  2. Changed Registry marked status Unknown; last known: Recruiting
  3. Trial status: Recruiting to Unknownv5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 1, 2023 to Apr 1, 2024
    • Study sites: 0 to 1
    • Study completion date: Aug 1, 2026 to Sep 1, 2026
    v3
  5. Eligibility criteria revisedv2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Cohort 1 primary end-point: Dose modification feasibility
Timeframe: 2-18 months after intervention initiation
Cohort 2 primary end-point: Disease Control Rate at 12 weeks
Timeframe: 12 weeks after intervention initiation

Secondary (6)

Cohort 1 secondary end-point: plasma concentrations of osimertinib and AZ5104
Cohort 1 secondary end-point: safety set
Cohort 1 secondary end-point: Cost-effectiveness analysis
Cohort 1 secondary end-point: CYP3A predictiveness for osimertinib exposure
Cohort 2 secondary end-point: plasma concentrations of osimertinib and AZ5104
Show 1 moreShow less
Cohort 2 secondary end-point: safety set

Arms and interventions

Cohort 1: Adjusting osimertinib treatment plans with concomitant pk-boostingExperimental

Feasibility of using pharmacokinetic boosting and TDM to individualize treatment plans and dosage for osimertinib, in patients with advanced NSCLC with mutated EGFR. In this cohort, patients will receive cobicistat for pharmacokinetic boosting of standard osimertinib treatment. Afterwards, they will receive personalised treatment plans, guided by therapeutic drug monitoring.

Cohort 2: Improving osimertinib CNS penetration in patients with neurometastasesExperimental

Assessing whether pharmacokinetic boosting can improve CNS penetration of osimertinib, in patients with advanced NSCLC with mutated EGFR with asymptomatic CNS oligoprogression. Patients who experience progressive disease intracranially, are sometimes dose-escalated to try and improve osimertinib intracranial exposure. This study will look to demonstrate the feasibility of using a PK-booster instead, potentially providing patients the benefits of higher intracranial treatment efficacy, without needing to take extra osimertinib.

Drugs: Cobicistat

Sites

1 site in 1 country

  • MaastrichtUMCMaastricht, Limburg, Netherlands