A Phase 3 study (NCT05382728) involving osimertinib (Tagrisso) and TY-9591 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) reached primary completion on May 31, 2025. This milestone, reported by ClinicalTrials.gov, signifies that the main data collection phase for the trial has concluded.
Background
Osimertinib is an established treatment for non-small cell lung cancer (NSCLC), particularly in cases involving epidermal growth factor receptor (EGFR) activating mutations. This study investigates TY-9591 in comparison to osimertinib for this patient population.
Trial design
The study, titled "Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)," is a Phase 3 trial with an estimated enrollment of 680 participants. It is designed to assess the efficacy and safety of TY-9591 versus osimertinib in patients diagnosed with NSCLC and EGFR Activating Mutation. The interventions include ty-9591, placebo osimertinib, osimertinib, and placebo ty-9591.
What this means
The primary completion of this Phase 3 study indicates that all participants have completed their scheduled treatments and follow-up for the primary endpoint assessment. While results are not yet available, this milestone is a critical step towards the eventual analysis and reporting of the trial's findings, which will compare TY-9591 against osimertinib in this specific NSCLC patient group.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT05382728, titled "Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)," was recorded with a primary completion date of May 31, 2025 on clinicaltrials.gov.