X-396 Capsule in Advanced NSCLC Patients With ROS1 Gene Rearrangement

Status Recruiting

Clinical Trial Summary

To assess treatment effectiveness and safety of oral X-396 capsule (Ensartinib) administered to Chinese patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a c-ROS Oncogene (ROS1) positive gene mutation (translocation or inversion).

Clinical Trial Description

This is a phase II, multicenter, single-arm study in which the efficacy and safety of X-396 capsule (Ensartinib) will be assessed in adult Chinese patients with ROS1-positive (rearrangement or inversion) non-small cell lung cancer (NSCLC). Approximately 69 patients (59 for never-treated, and 10 for previously treated with crizotinib) with locally advanced or metastatic NSCLC carrying ROS1-rearrangement will be enrolled in the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03608007
Study type	Interventional
Source	Betta Pharmaceuticals Co., Ltd.
Contact	Jinxiao Xu
Phone	86-18610155290
Email	jinxiao.xu@bettapharma.com
Status	Recruiting
Phase	Phase 2
Start date	June 15, 2018
Completion date	September 2020

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