NCT05948813

TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases

A Phase II Study of TY-9591 Tablets in Patients With EGFR-Mutated Non-small Cell Lung Cancer With Brain Metastases

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: TYK Medicines, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the efficacy and safety of TY-9591 in first-line treatment of patients with EGFR-sensitive mutation-positive non-small cell lung cancer with brain metastases compared to Osimertinib.

Detailed description

This is an open label, multi-center phase II study to compare the efficacy and safety with Osimertinib in EGFR mutated NSCLC patients with brain metastases. Participants will be randomly assigned to one of the TY-9591 group (160mg orally, once daily) or Osimertinb group (80mg orally, once daily) . Participants can continue to receive study treatment as long as disease progression, meeting criteria for discontinuation of treatment, withdrawal criteria, or study termination (whichever occurred first).

Conditions

• NSCLC
• EGFR Activating Mutation
• Brain Metastases

Interventions

Type	Name	Description
DRUG	TY-9591	The dose of TY-9591 tablet is 160 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment until meet the of discontinuation criteria.
DRUG	Osimertinib	The dose of Osimertinib is 80 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment until meet the of discontinuation criteria.

Timeline

• Start date: 2023-08-17
• Primary completion: 2025-06-30
• Completion: 2027-12-30
• First posted: 2023-07-17
• Last updated: 2024-11-21

Locations

1 site across 1 country: China