Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels — ADAPT ALEC  

Lung Cancer Clinical Trial

Official title: Standard Dosed Alectinib Versus Therapeutic Drug Monitoring Guided Alectinib Dosing

Status Recruiting

Clinical Trial Summary

The ADAPT ALEC randomized controlled trial (RCT) is performed in patients with Anaplastic Lymphoma Kinase (ALK) positive non-small cell lung cancer (NSCLC). The RCT will compare the use of Therapeutic Drug Monitoring (TDM) and dose increases if alectinib 35 ng/Ml (arm A) with standard of care (arm B).

Clinical Trial Description

The ADAPT ALEC trial is a phase IV, RCT in patients with ALK positive NSCLC treated with alectinib. A longer median progression free survival (mPFS) is expected in patients treated with standard dose alectinib when minimum plasma concentrations (Cmin) of alectinib exceed 435 ng/mL. The ADAPT ALEC trial will investigate whether using therapeutic drug monitoring (TDM) and increasing the dose of alectinib in patients with Cmin <435 ng/mL, will raise the mPFS. We will compare mPFS in the subgroup of patients with an alectinib Cmin <435 ng/mL using TDM and dose increases (arm A) to fixed dosing/standard of care (arm B). ;

Related Conditions & MeSH terms

• Anaplastic Lymphoma Kinase Gene Mutation
• Anaplastic Lymphoma Kinase Gene Translocation
• Carcinoma, Non-Small-Cell Lung
• Drug Monitoring
• Lung Cancer
• Lymphoma

• NCT number: NCT05525338
• Study type: Interventional
• Source: University Medical Center Groningen
• Contact: M.B. Muntinghe-Wagenaar, Msc
• Phone: +31503616161
• Email: adaptalec@umcg.nl
• Status: Recruiting
• Phase: Phase 4
• Start date: March 23, 2022
• Completion date: December 31, 2026