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

Recruiting Phase 4 Interventional Study
Drug Monitoring Carcinoma, Non-Small-Cell Lung Lung Cancer Anaplastic Lymphoma Kinase Gene Mutation Anaplastic Lymphoma Kinase Gene Translocation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
196 (estimated)
Sponsor
University Medical Center Groningen · Other
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients with locally advanced or metastatic NSCLC (stage IIIB to stage IV by AJCC 8th) * ECOG performance status 0-4 * Histologically or cytology confirmed NSCLC * Documented ALK rearrangement based on an EMA approved test * Patients can either be chemotherapy-naïve or have r…
Contacts

M.B. Muntinghe-Wagenaar, Msc

+31503616161

adaptalec@umcg.nl

CONTACT