Actively Recruiting
Study of Zorifertinib as First Treatment for EGFR-Mutated Advanced Non-Small Cell Lung Cancer With Brain Spread
Led by Alpha Biopharma (Jiangsu) Co., Ltd. · Updated on 2026-02-09
800
Participants Needed
34
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating zorifertinib as a first-line treatment for patients with advanced non-small cell lung cancer NSCLC that has mutations in the EGFR gene and has spread to the central nervous system CNS. This prospective study involves multiple centers and compares the survival benefits and safety of zorifertinib to other similar drugs called EGFR tyrosine kinase inhibitors EGFR-TKIs. The study aims to better understand how well zorifertinib works and its clinical value in this patient group. Participants are divided into three groups those receiving first-line zorifertinib who meet criteria of the EVEREST study, those receiving zorifertinib but not meeting EVEREST criteria, and those receiving other anti-tumor drugs chosen by their doctors excluding zorifertinib. The EVEREST study is an open-label trial comparing zorifertinib to gefitinib or erlotinib. Treatments are given as prescribed by clinicians, with monitoring of safety and dosage adjustments as needed. During the study, participants will be followed for up to 36 months, with assessments every 8 weeks to measure overall survival, progression-free survival, intracranial progression, response rates, and adverse events. Researchers will track dose changes and monitor safety outcomes over time. The study collects clinical data to evaluate the effectiveness and tolerability of the treatments in patients with EGFR-mutant advanced NSCLC and CNS metastases.
CONDITIONS
Brief Title
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
Research Team
J
John Ge M.D.
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