Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05525338

Standard Dose Alectinib Versus Therapeutic Drug Monitoring Guided Dose Adjustment in ALK Positive Non-Small Cell Lung Cancer

Led by University Medical Center Groningen · Updated on 2024-05-13

196

Participants Needed

8

Research Sites

52 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 trial is a phase IV randomized controlled study involving patients with ALK-positive non-small cell lung cancer (NSCLC). It aims to compare standard dosing of alectinib with dosing guided by therapeutic drug monitoring (TDM) to see if adjusting doses based on blood drug levels improves outcomes. This research focuses on whether increasing alectinib doses in patients with low plasma concentrations can extend the time patients live without disease progression. Participants receive either standard fixed-dose alectinib or alectinib doses adjusted by TDM. If blood levels are below a certain threshold and toxicity is manageable, the dose may be increased in the TDM group, while dose reductions are allowed in both groups for unacceptable side effects. Alectinib plasma concentrations are measured but kept blinded during the trial, and patients may receive local radiotherapy for pain as needed. Throughout the study, patients will be monitored for progression-free survival, response rates, overall survival, brain metastasis progression, and treatment adherence, among other outcomes. Various quality of life questionnaires are completed every three months. The study includes a follow-up period of 12 months after treatment completion, with safety and effectiveness assessments continuing over an average of two years.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with locally advanced or metastatic NSCLC (stage IIIB to IV by AJCC 8th edition)
  • ECOG performance status between 0 and 4
  • Histologically or cytologically confirmed NSCLC
  • Documented ALK gene rearrangement by EMA approved test
  • Chemotherapy-naive patients or those with one prior platinum-based chemotherapy
  • Patients with asymptomatic and clinically stable brain or leptomeningeal metastases for at least 2 weeks without steroid treatment
  • Measurable disease by RECIST criteria version 1.1
  • Signed IRB/Ethical Committee approved informed consent
  • Participation in other observational studies allowed
  • Local radiotherapy permitted for pain management
Not Eligible

You will not qualify if you...

  • Any significant concurrent disease that could worsen with the study drug
  • Use of CYP3A4 modulators or QT prolonging agents within 14 days before and during the study
  • Any clinically significant disease or condition that could interfere with study conduct or drug absorption or pose unacceptable risk
  • Psychological, familial, sociological, or geographical issues likely to hinder compliance or follow-up

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 years

Participants receive alectinib with dosing either fixed or adjusted based on therapeutic drug monitoring of blood levels.

Visits every 2-3 months for assessments and therapeutic drug monitoring 4 to 6 weeks after dose adjustments

Follow-up

Duration - 12 months

Participants are monitored for progression-free survival, overall survival, quality of life, and adverse events after treatment completion.

Visits every 3 months for questionnaires and clinical assessments

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

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Research Team

M

M.B. Muntinghe-Wagenaar, Msc

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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Frequently Asked Questions

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Published Research Related To This Trial

Therapeutic drug monitoring guided dosing versus standard dosing of alectinib in advanced ALK positive non-small cell lung cancer patients: Study protocol for an international, multicenter phase IV randomized controlled trial (ADAPT ALEC).

Marinda Meertens, M Benthe Muntinghe-Wagenaar, Barend J Sikkema...

https://pubmed.ncbi.nlm.nih.gov/36969063