Spots Global Cancer Trial Database for X-396 Capsule in Advanced NSCLC Patients With ROS1 Gene Rearrangement

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Trial Identification

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

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

Study ID: NCT03608007

Conditions

Lung Cancer

ROS1 Gene Rearrangement

Interventions

X-396 Capsule

Study Description

Brief 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.