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

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 ab…