Comparing standard and adjusted doses of alectinib for lung cancer treatment
Standard Dosed Alectinib Versus Therapeutic Drug Monitoring Guided Alectinib Dosing
This study is testing if adjusting the dose of alectinib based on blood levels can help people with ALK positive lung cancer live longer without their disease getting worse compared to the standard dose.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | chemotherapy, alectinib |
| Locations | 8 sites (Villejuif, Val-de-Marne and 7 other locations) |
| Trial ID | NCT05525338 on ClinicalTrials.gov |
What this trial studies
The ADAPT ALEC trial is a phase IV randomized controlled trial focusing on patients with ALK positive non-small cell lung cancer (NSCLC). It aims to compare the effectiveness of standard dosing of alectinib with a therapeutic drug monitoring approach that adjusts doses based on blood levels of the drug. The study will evaluate whether increasing the dose of alectinib in patients with low plasma concentrations can improve median progression-free survival. Participants will be monitored for their alectinib blood levels to determine the appropriate dosing strategy.
Who should consider this trial
Good fit: Ideal candidates include patients with locally advanced or metastatic ALK positive NSCLC who have measurable disease and meet specific inclusion criteria.
Not a fit: Patients with symptomatic brain or leptomeningeal metastases or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with ALK positive NSCLC by optimizing alectinib dosing.
How similar studies have performed: Other studies have shown promise in using therapeutic drug monitoring for cancer treatments, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Villejuif, Val-de-Marne and 7 other locations
- Gustave Roussy — Villejuif, Val-de-Marne, France (Not_yet_recruiting)
- Radboud University Medical Center — Nijmegen, Gelderland, Netherlands (Recruiting)
- Maastricht University Medical Center + — Maastricht, Limburg, Netherlands (Recruiting)
- The Netherlands Cancer Institute — Amsterdam, North Holland, Netherlands (Recruiting)
- Amsterdam University Medical Center — Amsterdam, North Holland, Netherlands (Recruiting)
- Leiden University Medical Center — Leiden, South Holland, Netherlands (Recruiting)
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: A.J. van der Wekken, PhD — University Medical Center Groningen
- Study coordinator: M.B. Muntinghe-Wagenaar, Msc
- Email: adaptalec@umcg.nl
- Phone: +31503616161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.