NCT04808752

Almonertinib as First-line Treatment in Patients With EGFR Mutations Positive in Advanced NSCLC With Brain Metastases

High-dose Almonertinib(HS-10296) as First-line Treatment in Patients With EGFR-sensitive Mutations in Advanced NSCLC With Brain Metastases: Prospective, Open-label, Multi-center, Single-arm Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label, multi-center, single-arm clinical trial

Detailed description

This is a prospective, open-label, multi-center, single-arm clinical trial aimed at patients with advanced non-small cell lung cancer (NSCLC) with asymptomatic brain metastases with epidermal growth factor receptor sensitive mutations (EGFRm+) who have not received any systemic treatment To evaluate the effectiveness and safety of high-dose almonertinib mesylate.Eligible patients were included in the high-dose almonertinib treatment group and received oral almonertinib 165 mg once a day.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Almonertinib	Patients meeting the criteria for inclusion and exclusion were included in the high-dose almonertinib treatment group and received oral almonertinib 165 mg once a day.

Timeline

• Start date: 2021-07-09
• Primary completion: 2024-06-15
• Completion: 2024-07-15
• First posted: 2021-03-22
• Last updated: 2024-04-22

Locations

1 site across 1 country: China