Comparing standard and adjusted doses of alectinib for lung cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ADAPT ALEC trial is a phase IV randomized controlled trial focusing on patients with ALK positive non-small cell lung cancer (NSCLC). It aims to compare the effectiveness of standard dosing of alectinib with a therapeutic drug monitoring approach that adjusts doses based on blood levels of the drug. The study will evaluate whether increasing the dose of alectinib in patients with low plasma concentrations can improve median progression-free survival. Participants will be monitored for their alectinib blood levels to determine the appropriate dosing strategy.

Why it matters

Who can join: the full rules

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 received one line of platinum-based chemotherapy
* Patients with brain or leptomeningeal metastases are allowed on the study if the lesions are asymptomatic without neurological signs and clinically stable for at least 2 weeks without steroid treatment. Patients who do not meet these criteria are not eligible for the study
* Measurable disease (by RECIST criteria version 1.1) prior to the first dose of study treatment
* Signed writte Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form, prior to performing any study-related procedures
* Observational other studies are allwoed for patients included in this study
* Local radiotherapy is allowed for pain

Exclusion Criteria:

* Any significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug
* Consumption of agents which modulate CYP3A4 or agents with potential QT prolonging effects within 14 days prior to admission and during the study (see concomitant medication restrictions)
* Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or absorption of oral medications, or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the subject in this study.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry.

Where it's running

• Radboud University Medical Center
  Nijmegen, Gelderland, Netherlands Recruiting
• Maastricht University Medical Center +
  Maastricht, Limburg, Netherlands Recruiting
• The Netherlands Cancer Institute
  Amsterdam, North Holland, Netherlands Recruiting
• Amsterdam University Medical Center
  Amsterdam, North Holland, Netherlands Recruiting
• Leiden University Medical Center
  Leiden, South Holland, Netherlands Recruiting
• Erasmus Medical Center
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Principal investigator: A.J. van der Wekken, PhD — University Medical Center Groningen
• Study coordinator: M.B. Muntinghe-Wagenaar, Msc
• Email: adaptalec@umcg.nl
• Phone: +31503616161

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.