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New treatment option for Drug Monitoring
Official title Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels
ClinicalTrials.gov ID: NCT05525338
What this study is testing
What is Alectinib?
Alectinib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for drug monitoring.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
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...
- Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct...
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol requirements and/or...
See the full eligibility 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...
- 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Villejuif, Val-de-Marne, France
- Nijmegen, Gelderland, Netherlands
- Maastricht, Limburg, Netherlands
- Amsterdam, North Holland, Netherlands
- Leiden, South Holland, Netherlands
- Rotterdam, South Holland, Netherlands
- Groningen, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Villejuif, Val-de-Marne, France; Nijmegen, Gelderland, Netherlands; Maastricht, Limburg, Netherlands; Amsterdam, North Holland, Netherlands; Leiden, South Holland, Netherlands; Rotterdam, South Holland, Netherlands and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.