Actively Recruiting
Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels
Led by University Medical Center Groningen · Updated on 2024-05-13
196
Participants Needed
8
Research Sites
249 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
A
Amsterdam University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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-nafve or have received one line of platinum-based chemotherapy
- Patients with brain or leptomeningeal metastases are allowed if lesions are asymptomatic, stable for at least 2 weeks without steroids
- Measurable disease by RECIST criteria version 1.1 prior to first dose
- Signed IRB/EC approved informed consent form
- Participation allowed in observational other studies
- Local radiotherapy allowed for pain
You will not qualify if you...
- Any significant concomitant disease that may worsen with the investigational drug
- Use of agents affecting CYP3A4 or with potential QT prolonging effects within 14 days prior and during study
- Any clinically significant disease or condition interfering with study conduct or oral medication absorption or posing unacceptable risk
- Psychological, familial, sociological or geographical conditions that may hinder compliance or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Gustave Roussy
Villejuif, Val-de-Marne, France, 94805
Not Yet Recruiting
2
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
3
Maastricht University Medical Center +
Maastricht, Limburg, Netherlands, 6229 HX
Actively Recruiting
4
The Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands, 1066 CX
Actively Recruiting
5
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
6
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
7
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
8
University Medical Center Groningen
Groningen, Netherlands, 9713GZ
Actively Recruiting
Research Team
M
M.B. Muntinghe-Wagenaar, Msc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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