NCT07143045

A Prospective Cohort Study of Zorifertinib as a First-line Treatment in Patients With Epidermal Growth Factor Receptor-mutant Advanced Non-small Cell Lung Cancer With Central Nervous System (CNS) Metastases

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Alpha Biopharma (Jiangsu) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a patient-centered, two-group, three-cohort, multi-center, prospective study to further evaluate the survival benefits and safety of zorifertinib as a first-line treatment in EGFRm+ advanced NSCLC patients with CNS metastases, and to compare the clinical value of zorifertinib with other epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs).

Conditions

• EGFR Mutant Advanced Non-small Cell Lung Cancer
• Central Nervous System (CNS) Metastases

Interventions

Type	Name	Description
DRUG	zorifertinib	Cohort A and B will receive zorifertinib as first line treatment

Timeline

• Start date: 2025-12-29
• Primary completion: 2031-05-01
• Completion: 2031-11-01
• First posted: 2025-08-27
• Last updated: 2026-02-09

Locations

34 sites across 1 country: China