{"entity":{"id":"fleteo","kind":"trial","name":"Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)","aka":["FLETEO"],"tldr":"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.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05382728","url":"https://clinicaltrials.gov/study/NCT05382728"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["ty-9591"],"companies":["tyk-medicines"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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","started":"2022-06-08","startedType":"actual","enrolled":680,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/fleteo/","neighbours":{"cancer":[{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"drug":[{"id":"ty-9591","kind":"drug","name":"TY-9591","route":"/drugs/ty-9591/"}],"company":[{"id":"tyk-medicines","kind":"company","name":"TYK Medicines","route":"/companies/tyk-medicines/"}]}}