Clin2
NCT05525338Possibly a fitRecruiting

Test standard vs adjusted alectinib dose using blood levels

Drug MonitoringCarcinoma, Non-Small-Cell LungLung CancerAnaplastic Lymphoma Kinase Gene MutationAnaplastic Lymphoma Kinase Gene Translocation

Treatments studied

Part of Cancer, Lungs & breathing clinical trials.

This trial compares the usual dose of alectinib with a modified dose chosen by checking alectinib blood levels. It aims to see whether adjusting the dose based on blood testing can work as well (and possibly be better tolerated) for people with ALK-positive non-small cell lung cancer.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 4
Enrollment
196 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have non-small cell lung cancer that is locally advanced or has spread (stage IIIB to stage IV)
  • Your cancer test shows an ALK gene change (using an approved test)
  • You can do daily activities at a level the study allows (ECOG 0–4)
  • Your cancer has measurable tumors on scans (meets RECIST 1.1)
  • You have not taken certain medicines that can affect drug breakdown (CYP3A4 medicines) or that can affect heart rhythm (QT-prolonging) within 14 days of starting
  • If you have brain or covering-of-brain (leptomeningeal) metastases, they must be symptom-free, stable for at least 2 weeks, and you cannot be using steroid treatment for them

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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