RecruitingPhase 4NCT05525338

Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels

Standard Dosed Alectinib Versus Therapeutic Drug Monitoring Guided Alectinib Dosing


Sponsor

University Medical Center Groningen

Enrollment

196 participants

Start Date

Mar 23, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches to dosing alectinib, a targeted therapy pill, in people with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called an ALK rearrangement. One group receives the standard dose; the other receives a dose adjusted based on blood levels of the drug. **You may be eligible if...** - You have locally advanced or metastatic NSCLC (stage IIIB–IV) confirmed by tissue or cell testing - Your tumor has a confirmed ALK rearrangement - You have either not yet had chemotherapy or have received one round of platinum-based chemotherapy - You have measurable disease on imaging scans - You have brain or leptomeningeal metastases that are stable and not causing symptoms **You may NOT be eligible if...** - You are currently taking medications that significantly affect how the liver processes drugs (CYP3A4 inhibitors/inducers) or drugs that can prolong the heart's electrical activity - You have another serious medical condition that the investigator believes would be worsened by alectinib Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlectinib

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.


Locations(8)

Gustave Roussy

Villejuif, Val-de-Marne, France

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Maastricht University Medical Center +

Maastricht, Limburg, Netherlands

The Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands

Amsterdam University Medical Center

Amsterdam, North Holland, Netherlands

Leiden University Medical Center

Leiden, South Holland, Netherlands

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

University Medical Center Groningen

Groningen, Netherlands

View Full Details on ClinicalTrials.gov

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NCT05525338


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