NCT04641754

A Study Evaluates the Safety and Efficacy of WX-0593 in ALK -Positive, or ROS1-positive Non-small Cell Lung Cancer

Phase II Clinical Study to Evaluate the Efficacy and Safety of WX-0593 in Patients With Crizotinib-resistant ALK -Positive, or Crizotinib-resistant/Crizotinib-naive ROS1-positive Non-small Cell Lung Cancer (NSCLC)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate safety and efficacy of WX-0593 oral tablets in ALK -positive, or ROS1-positive non-small cell lung cancer (NSCLC)

Detailed description

The clinical study is a single-arm, phase II, open label, multicenter design in patients with crizotinib-resistant ALK -positive, or crizotinib-resistant/crizotinib-naive ROS1-positive NSCLC.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	WX-0593 Tablets	tablets, 60 mg→180mg, quaque die（QD）

Timeline

• Start date: 2019-03-07
• Primary completion: 2020-12-01
• Completion: 2021-03-01
• First posted: 2020-11-24
• Last updated: 2020-11-24

Locations

41 sites across 1 country: China