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).
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
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.
Parallel
Alectinib
DrugIn case of an alectinib plasmaconcentration Cmin \<435 ng/mL, determined by TDM, and manageable toxicity, the alectinib dose will be increased with 150mg BID up to a maximum of 900mg BID. In case of unacceptable toxicity (i.e. unbearable or persistent grade 2 toxicity and grade 3/4 toxicity), the alectinib dose can be reduced by 150mg BID.
Median progression free survival (mPFS)
PFS is measured from start of treatment to progressive disease, death or lost to follow-up.Patients who did not die or progress, or lost to follow-up, will be censored at their last available date.
Succesfull Therapeutic Drug monitoring
The percentage of succesfull TDM interventions, in which successful is defines as tartget attainment and manageable toxicity.
Overall response rate (ORR)
ORR is the percentage of patients with partial response or complete response, according to RECIST v1.1, of the total treated population.
Median overall survival
mOS is defined as time from randomization to death from any cause in the total population.
Intracranial PFS
PFS is measured from start of treatment to progressive disease in the brain, death or lost to follow-up. Patients who did not die or progress, or lost to follow-up, will be censored at their last available date.
Click on the lead sponsor to view all of their trials.
University Medical Center Groningen
Lead sponsor
Amsterdam University Medical Center
Collaborator
Erasmus Medical Center
Collaborator
Maastricht University Medical Center
Collaborator
Radboud University Medical Center
Collaborator
The Netherlands Cancer Institute
Collaborator
Leiden University Medical Center
Collaborator
