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

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).

Trial Details

NCT ID
NCT05525338
Phase
PHASE4
Sponsor
University Medical Center Groningen
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Alectinib
Locations (sample)
  • Villejuif, Val-de-Marne, France|48.7939,2.35992
  • Nijmegen, Gelderland, Netherlands|51.8425,5.85278
  • Maastricht, Limburg, Netherlands|50.84833,5.68889
  • Amsterdam, North Holland, Netherlands|52.37403,4.88969
  • Amsterdam, North Holland, Netherlands|52.37403,4.88969

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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