NCT07361705

Zorifertinib With Osimertinib for NSCLC With Meningeal Progression

An Open-Label, Multicentre, Phase 1 Clinical Study to Evaluate the Safety and Efficacy of Zorifertinib Combined With Osimertinib in Patients With Advanced Non-Small Cell Lung Cancer With Meningeal Progression After Osimertinib Treatment

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Alpha Biopharma (Jiangsu) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical trial that aims to test Zorifertinib when used together with a known drug, Osimertinib. The goal is to learn if this combination is safe and works for people with advanced Non-Small Cell Lung Cancer (NSCLC) whose cancer has spread to the membranes surrounding the brain and spinal cord (a condition called leptomeningeal metastases) after being treated with Osimertinib.

Conditions

• Patients With Advanced Non-small Cell Lung Cancer With Meningeal Progression After Osimertinib Treatment

Interventions

Type	Name	Description
DRUG	Zorifertinib and Osimertinib Combination Therapy	Zorifertinib is an oral tablet (50 mg or 100 mg). Osimertinib is an oral tablet (80 mg). In this Phase 1 study, all participants will receive the combination. Osimertinib is given at a fixed dose of 80 mg once daily. Zorifertinib is given twice daily, with dose levels under evaluation (starting at 100 mg BID, potentially escalating to 150 mg BID, 200 mg BID, or higher). Dose escalation follows a "3+3" design based on dose-limiting toxicity (DLT) assessment in the first 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or meeting other discontinuation criteria.

Timeline

• Start date: 2026-01-31
• Primary completion: 2028-04-23
• Completion: 2028-09-15
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: China