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

> **NCT05382728** · PHASE3 · RECRUITING · sponsor: **TYK Medicines, Inc** · enrollment: 680 (estimated)

## Conditions studied

- NSCLC
- EGFR Activating Mutation

## Interventions

- **DRUG:** TY-9591
- **DRUG:** placebo Osimertinib
- **DRUG:** Osimertinib
- **DRUG:** placebo TY-9591

## Key facts

- **NCT ID:** NCT05382728
- **Lead sponsor:** TYK Medicines, Inc
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2022-06-08
- **Primary completion:** 2025-05
- **Final completion:** 2027-12
- **Target enrollment:** 680 (ESTIMATED)
- **Last updated:** 2024-01-30


## Primary source

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

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05382728, "Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT05382728. Licensed CC0.

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