Alectinib: In 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Median progression free survival (mPFS) — mPFS will be assessed through study completion, after 12 months of follow-up. 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.
Trial sites (8)
Facility
City
Region
Status
Gustave Roussy
Villejuif
Val-de-Marne
Not Yet Recruiting
Radboud University Medical Center
Nijmegen
Gelderland
Recruiting
Maastricht University Medical Center +
Maastricht
Limburg
Recruiting
The Netherlands Cancer Institute
Amsterdam
North Holland
Recruiting
Amsterdam University Medical Center
Amsterdam
North Holland
Recruiting
Leiden University Medical Center
Leiden
South Holland
Recruiting
Erasmus Medical Center
Rotterdam
South Holland
Recruiting
University Medical Center Groningen
Groningen
Netherlands
Recruiting
More University Medical Center Groningen trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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