Clinical Trial

Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels

Study acronym: ADAPT ALEC
Recruiting Phase 4
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Record status
This record was last updated May 13, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-08-30; most recent amendment 2024-05-10.
Trial Details
NCT Number NCT05525338
Lead Sponsor University Medical Center Groningen
Collaborators: Amsterdam University Medical Center, Erasmus Medical Center, Maastricht University Medical Center, Radboud University Medical Center, The Netherlands Cancer Institute, Leiden University Medical Center
Conditions Drug Monitoring, Carcinoma, Non-Small-Cell Lung, Lung Cancer, Anaplastic Lymphoma Kinase Gene Mutation, Anaplastic Lymphoma Kinase Gene Translocation
Enrollment 196 participants
Start Date 2022-03-23
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-05-13