Spots Global Cancer Trial Database for Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)
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Trial Identification
Brief Title: Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)
Official Title: 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.
Study ID: NCT05382728
Study Description
Brief Summary: To assess the efficacy and safety of TY-9591 versus Osimertinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer.
Detailed Description: This is a Phase III, double-blind, randomised study assessing the efficacy and safety of TY-9591 versus Osimertinib in patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) that is known to be EGFR sensitising mutation (EGFRm) positive, treatment-naïve and eligible for first-line treatment with an EGFR-TKI.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hunan Provincial Tumor Hospital, Changsha, Hunan, China
Shanghai Chest Hospital, Shanghai, Shanghai, China
Contact Details
Name: Baohui Han, MD
Affiliation: Shanghai Chest Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Lin Wu, MD
Affiliation: Hunan Cancer Hospital
Role: PRINCIPAL_INVESTIGATOR
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