rEaL-world pharmacokinetics of Immune Checkpoint InhibiTors (ELICIT)

Phase 4

Recruiting

• Conditions: lung cancer; NSCLC; 10038666

• Registration Number: NL-OMON51955
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

- Treatment with the ICIs mentioned in paragraph 4.1
- Willingness and ability to provide written IC
- Age 18 years or older

Exclusion Criteria

Since we aim to assess the real-world pharmacokinetics, we will not make use of
any exclusion criteria.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>At multiple time points, blood samples will be obtained to determine the<br /><br>following pharmacokinetic characteristics of ICIs:<br /><br><br /><br>- Trough concentration (Cmin)<br /><br>- Peak concentration (Cmax)<br /><br>- Clearance (Cl) at baseline (Clbl) and change in clearance (compared to Cl at<br /><br>end of treatment) (&Delta;Cl), e.g. by Bayesian estimation using established and<br /><br>validated population pharmacokinetic models, as published by the manufacturer<br /><br>- Volume of distribution (Vd)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>