Lung Cancer Clinical Trial
— ADAPT ALECOfficial title:
Standard Dosed Alectinib Versus Therapeutic Drug Monitoring Guided Alectinib Dosing
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).
Status | Recruiting |
Enrollment | 196 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Gustave Roussy | Villejuif | Val-de-Marne |
Netherlands | Amsterdam University Medical Center | Amsterdam | Noord-Holland |
Netherlands | The Netherlands Cancer Institute | Amsterdam | Noord-Holland |
Netherlands | University Medical Center Groningen | Groningen | |
Netherlands | Leiden University Medical Center | Leiden | Zuid-Holland |
Netherlands | Maastricht University Medical Center + | Maastricht | Limburg |
Netherlands | Radboud University Medical Center | Nijmegen | Gelderland |
Netherlands | Erasmus Medical Center | Rotterdam | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen | Amsterdam University Medical Center, Erasmus Medical Center, Leiden University Medical Center, Maastricht University Medical Center, Radboud University Medical Center, The Netherlands Cancer Institute |
France, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Median progression free survival (mPFS) | PFS is measured from start of treatment to progressive disease, death or lost to follow-up.Patients who did not die or progress, or lost to follow-up, will be censored at their last available date. | mPFS will be assessed through study completion, after 12 months of follow-up. | |
Secondary | Succesfull Therapeutic Drug monitoring | The percentage of succesfull TDM interventions, in which successful is defines as tartget attainment and manageable toxicity. | 4 to 6 weeks after dose adjustment based on TDM | |
Secondary | Overall response rate (ORR) | ORR is the percentage of patients with partial response or complete response, according to RECIST v1.1, of the total treated population. | Response will be assessed every 2-3 months. ORR will be determined after total study completion and 12 months of follow-up | |
Secondary | Median overall survival | mOS is defined as time from randomization to death from any cause in the total population. | Through total study completion, after 12 months of follow-up | |
Secondary | Intracranial PFS | PFS is measured from start of treatment to progressive disease in the brain, death or lost to follow-up. Patients who did not die or progress, or lost to follow-up, will be censored at their last available date. | Progressive disease will be assessed once every 2-3 months. Intracranial PFS will be assessed through total study completion, after 12 months of follow-up | |
Secondary | Patient adherence to alectinib treatment | This will be estimated by pill counts of returned medication as well as a patient diary on drug intake. | Through study completion, an average of 2 years | |
Secondary | Number of adverse events (AE) related to plasma concentration and dose increases | AE's will be defined using CTCAE v5.0. Number of AE's in the subgroups of patients with Cmin <435 ng/mL compared to Cmin >= 435 ng/ML, and in patients who did and who did not receive a TDM-guided dose increase. | Through total study completion, after 12 months of follow-up | |
Secondary | European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC QLQ-C30) and the the Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC-13) module | Mean change from baseline in EORTC QLQ-C30 and QLQ-LC13 scores | Questionnaires will be filled in at baseline and every 3 months thereafter through study completion, an average of 2 years. | |
Secondary | European Quality of Life Five Dimensions with five levels (EQ-5D-5L) questionnaire | Mean change from baseline in EQ-5D-5L score | Questionnaire will be filled in at baseline and every 3 months thereafter through study completion, an average of 2 years. | |
Secondary | Incremental cost-effectiveness ratio (ICER) | The ICER is the final outcome of the comparative cost-effectiveness analysis performed using a health-state transition model to compare costs and effectiveness between both study arms. | Through total study completion, after 12 months of follow-up | |
Secondary | Alectinib M4 protein | Alectinib M4 plasmaconcentrations in relation to alectinib plasma concentrations | Through total study completion, after 12 months of follow-up |
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