Spots Global Cancer Trial Database for Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels

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Trial Identification

Brief Title: Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels

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

Study ID: NCT05525338

Conditions

Drug Monitoring

Carcinoma, Non-Small-Cell Lung

Lung Cancer

Anaplastic Lymphoma Kinase Gene Mutation

Anaplastic Lymphoma Kinase Gene Translocation

Interventions

Alectinib

Study Description

Brief 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).

Detailed 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).