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Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels (ADAPT ALEC)
EU CTIS ID: 2023-506886-76-00
What this study is testing
The primary objective will be a prolonged mPFS for the TDM-guided dosing cohort versus the standard fixed dosing cohort in the group of patients with an alectinib Cmin below the threshold of <435 ng/mL.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with locally advanced or metastatic NSCLC (stage IIIB to stage IV by AJCC 8th)
- Observational other studies are allowed for patients included in this study
- Local radiotherapy is allowed for pain
- Male or female >=18 years old
- ECOG Performance Status of 0-4
- Histologically or cytology confirmed NSCLC
You likely can't join if
- 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 patiënt before trial entry.
See the full eligibility criteria
- Patients with locally advanced or metastatic NSCLC (stage IIIB to stage IV by AJCC 8th)
- Observational other studies are allowed for patients included in this study
- Local radiotherapy is allowed for pain
- Male or female >=18 years old
- ECOG Performance Status of 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 platinumbased 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 written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form, prior to performing any study-related procedures.
- 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 patiënt before trial entry.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.