NCT05146219

Study of TY-9591 in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR Mutation

A Phase II, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of TY-9591 Tablets in Patients With EGFR-Mutated Non-small Cell Lung Cancer With Brain or Leptomeningeal Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: TYK Medicines, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of TY-9591 tablets in the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC) patients with brain or leptomeningeal metastases.

Detailed description

This is an open label, multi-center phase II study to evaluate the efficacy and safety in EGFR mutated NSCLC patients with brain or leptomeningeal metastases. The patients will be assigned to the appropriate treatment cohorts based on the criteria.

Conditions

• NSCLC
• EGFR Activating Mutation
• Brain Metastases
• Leptomeningeal Metastasis

Interventions

Type	Name	Description
DRUG	TY-9591 Tablets	TY-9591 Tablets 160mg/d

Timeline

• Start date: 2022-04-02
• Primary completion: 2024-03-21
• Completion: 2024-11-13
• First posted: 2021-12-06
• Last updated: 2024-12-30

Locations

1 site across 1 country: China