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X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases

Brain Metastases Clinical Trial

Official title:
Efficacy and Safety of X-396 (Ensartinib) in ALK-Positive NSCLC Patients With Brain Metastases: A Phase Ⅱ, Open-Label, Single Arm, Multicenter Study

Clinical Trial Summary

To assess efficacy and safety of oral X-396 (Ensartinib) capsule in Chinese ALK-positive NSCLC patients with brain metastases, eligible patients will be enrolled with objective responses being primary outcome measures.

Clinical Trial Description

In this phase Ⅱ, open-label, single arm, multicenter study, efficacy and safety of oral X-396 capsule (Ensartinib) in 37 Chinese ALK-positive NSCLC patients with brain metastases will be assessed. Eligible patients will receive 225mg X-396 capsules once daily and objective responses of brain metastasis based on investigator assessment according to Response Assessment in Neuro-Oncology (RANO) are primary outcome measures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04415320
Study type Interventional
Source Betta Pharmaceuticals Co., Ltd.
Contact Jianhua Chang
Phone 8613916619284
Email changjianhua@163.com
Status Recruiting
Phase Phase 2
Start date March 21, 2019
Completion date June 2021
View Details
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