Phase IV Trial Comparing Standard Dose Alectinib to Dose Adjusted by Therapeutic Drug Monitoring in ALK Positive Non-Small Cell Lung Cancer

What this Trial Is About

The ADAPT ALEC trial is a phase IV randomized controlled study involving patients with ALK-positive non-small cell lung cancer NSCLC. It aims to compare standard dosing of alectinib with dosing guided by therapeutic drug monitoring TDM to see if adjusting doses based on blood drug levels improves outcomes. This research focuses on whether increasing alectinib doses in patients with low plasma concentrations can extend the time patients live without disease progression. Participants receive either standard fixed-dose alectinib or alectinib doses adjusted by TDM. If blood levels are below a certain threshold and toxicity is manageable, the dose may be increased in the TDM group, while dose reductions are allowed in both groups for unacceptable side effects. Alectinib plasma concentrations are measured but kept blinded during the trial, and patients may receive local radiotherapy for pain as needed. Throughout the study, patients will be monitored for progression-free survival, response rates, overall survival, brain metastasis progression, and treatment adherence, among other outcomes. Various quality of life questionnaires are completed every three months. The study includes a follow-up period of 12 months after treatment completion, with safety and effectiveness assessments continuing over an average of two years.

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