Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels
Trial Parameters
Brief Summary
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).
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 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 Exclusio