Trial Title:
Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels
NCT ID:
NCT05525338
Condition:
Drug Monitoring
Carcinoma, Non-Small-Cell Lung
Lung Cancer
Anaplastic Lymphoma Kinase Gene Mutation
Anaplastic Lymphoma Kinase Gene Translocation
Conditions: Official terms:
Lymphoma
Carcinoma, Non-Small-Cell Lung
Alectinib
Conditions: Keywords:
Alectinib
Randomized Controlled Trial
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Both study-arms will receive oral alectinib (Alecensa®, Roche). In arm A (TDM arm), the
alectinib dose will be increased if Cmin <435 ng/mL and manageable toxicity. In both
arms, alectinib dose can be reduced based on toxicity.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
The alectinib Cmin for patients treated in arm B (standard dose arm) will be blinded to
participants and care providers
Intervention:
Intervention type:
Drug
Intervention name:
Alectinib
Description:
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.
Arm group label:
TDM-guided dosing arm
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).
Detailed description:
The ADAPT ALEC trial is a phase IV, RCT in patients with ALK positive NSCLC treated with
alectinib. A longer median progression free survival (mPFS) is expected in patients
treated with standard dose alectinib when minimum plasma concentrations (Cmin) of
alectinib exceed 435 ng/mL. The ADAPT ALEC trial will investigate whether using
therapeutic drug monitoring (TDM) and increasing the dose of alectinib in patients with
Cmin <435 ng/mL, will raise the mPFS. We will compare mPFS in the subgroup of patients
with an alectinib Cmin <435 ng/mL using TDM and dose increases (arm A) to fixed
dosing/standard of care (arm B).
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
B. Besse, PhD
Facility:
Name:
Radboud University Medical Center
Address:
City:
Nijmegen
Zip:
6525 GA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
M.M. van den Heuvel, PhD
Facility:
Name:
Maastricht University Medical Center +
Address:
City:
Maastricht
Zip:
6229 HX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
L.E.L. Hendriks, PhD
Facility:
Name:
The Netherlands Cancer Institute
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
A.J. de Langen, PhD
Facility:
Name:
Amsterdam University Medical Center
Address:
City:
Amsterdam
Zip:
1105 AZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
S.M.S. Hashemi, Msc
Facility:
Name:
Leiden University Medical Center
Address:
City:
Leiden
Zip:
2333 ZA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
E.F. Smit, PhD
Facility:
Name:
Erasmus Medical Center
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
A.C. Dingemans, PhD
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9713GZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
A.J. van der Wekken, PhD
Start date:
March 23, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
University Medical Center Groningen
Agency class:
Other
Collaborator:
Agency:
Amsterdam University Medical Center
Agency class:
Other
Collaborator:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
Maastricht University Medical Center
Agency class:
Other
Collaborator:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Leiden University Medical Center
Agency class:
Other
Source:
University Medical Center Groningen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05525338
