# Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)

Source: https://onco.cc/trials/fleteo/  
OnCo record `fleteo` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing TY-9591 in non-small-cell lung cancer, now recruiting.

## Summary

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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Also known as: FLETEO
- Tags: ctgov-ingest
- Registry id: NCT05382728
- Phase: 3
- Setting: A Phase III, Randomised, Double-blind, Multi-center 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
- Sponsor: TYK Medicines
- Enrolled: 680

## Sources

- ClinicalTrials.gov NCT05382728: https://clinicaltrials.gov/study/NCT05382728

## Connected records

- cancers: [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- drugs: [TY-9591](https://onco.cc/drugs/ty-9591/)
- companies: [TYK Medicines](https://onco.cc/companies/tyk-medicines/)

---
JSON: https://onco.cc/api/v1/entities/fleteo.json