NCT03608007

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

Phase II, Open-Label, Single Arm Study of the Efficacy and Safety of X-396 Capsule in Patients With ROS1 Positive Advanced NSCLC

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Lung Cancer
• ROS1 Gene Rearrangement

Interventions

Type	Name	Description
DRUG	X-396 Capsule	225 mg once daily

Timeline

• Start date: 2018-06-15
• Primary completion: 2020-03-01
• Completion: 2020-09-01
• First posted: 2018-07-31
• Last updated: 2020-01-09

Locations

1 site across 1 country: China