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A phase 3 trial testing TY-9591 in non-small-cell lung cancer, now recruiting.
Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO) is a phase 3 interventional study registered as NCT05382728, led by TYK Medicines, and recruiting on the registry. Official title: A Phase III, Randomised, Double-blind, Multi-centre Study to Assess the Efficacy and Safety of TY-9591 Tablets Versus Osimertinib as First Line Treatment in Patients With EGFR-sensitive Mutation, Locally Advanced or Metastatic Non Small Cell Lung Cancer. Planned enrolment is 680 participants (estimated). The study started in 2022-06-08 and primary completion is expected in 2025-05. No results have been posted on ClinicalTrials.gov.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
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