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

NCT05525338 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2024-05-13

No results posted yet for this study

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).

Conditions

  • Drug Monitoring
  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Anaplastic Lymphoma Kinase Gene Mutation
  • Anaplastic Lymphoma Kinase Gene Translocation

Interventions

DRUG

Alectinib

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.

Sponsors & Collaborators

  • Amsterdam University Medical Center

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Maastricht University Medical Center

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • A.J. van der Wekken, PhD · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-23
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • France
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05525338 on ClinicalTrials.gov