Compares standard alectinib dosing with blood-level-guided dosing in lung cancer
Tests adjusting alectinib dose by blood levels in adults with ALK-positive lung cancer.
Plain-language title generated from the registry record
Registry title: Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels
Key facts
- Where
- Amsterdam, Groningen, Leiden, Maastricht, Nijmegen, Rotterdam, and Utrecht, NetherlandsSee the 8 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with ALK-positive non-small cell lung cancer that is locally advanced or has spread. It compares standard alectinib dosing with dosing adjusted to blood levels of the drug.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Non-small cell lung cancer (NSCLC), locally advanced or metastatic (stage IIIB to stage IV), confirmed by tissue or cell tests, with disease that can be measured (RECIST 1.1). Brain or leptomeningeal metastases are allowed only if they cause no symptoms or neurological signs and have been stable for at least 2 weeks without steroid treatment.
- Earlier treatment
- People can have had no chemotherapy, or one line of platinum-based chemotherapy. Agents that change CYP3A4 or can prolong the QT interval cannot be taken within 14 days before admission and during the study.
- Biomarker or test result
- A documented ALK rearrangement, shown by an EMA approved test
Main reasons for not taking part
- A significant other disease that the study drug could make worse
- Taking agents that modulate CYP3A4 or can prolong the QT interval within 14 days before admission or during the study
- A condition that could interfere with the study or with absorption of oral medicines
- A condition that poses an unacceptable risk, in the investigator's opinion
- Psychological, family, social or geographical conditions that could make it hard to follow the study plan
Read by machine on 12 November 2026.
Where in Netherlands
- Amsterdam UMCAmsterdam, NetherlandsTaking people
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, NetherlandsTaking people
- Universitair Medisch Centrum GroningenGroningen, NetherlandsTaking people
- Leids Universitair Medisch Centrum (LUMC)Leiden, NetherlandsTaking people
- University Hospital MaastrichtMaastricht, NetherlandsTaking people
- Radboud Universitair Medisch Centrum (Radboudumc)Nijmegen, NetherlandsTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
- Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Medical Center Groningen
- Trial code
- NCT05525338EU 2023-506886-76-00
- Record updated
- 13 May 2024
- Original description
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).Read full original descriptionShow less
Standard Dosed Alectinib Versus Therapeutic Drug Monitoring Guided Alectinib Dosing
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).
Inclusion: 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: Any significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug; 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; 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).