NCT04632758

Study Comparing WX-0593 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

An Open-label, Randomized, Multicenter Phase 3 Study Comparing WX-0593 to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the efficacy and safety of WX-0593 vs. crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy

Detailed description

To evaluate the efficacy and safety of WX-0593 vs. crizotinib in patients with ALK-positive NSCLC who had not received prior systemic therapy, to obtain additional pharmacokinetic (PK) data from sparse PK sampling, to compare the quality of life (QoL) in patients receiving WX-0593 vs. crizotinib, to evaluate the status of exploratory biomarkers and correlate with clinical outcome, and to obtain germline DNA samples for possible pharmacogenetic analysis in the event that outliers with respect to efficacy, tolerability/safety, or exposure are identified.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	WX-0593 Tablets	tablets, 60 mg→180mg, QD
DRUG	crizotinib	Capsules, 250mg, BID

Timeline

• Start date: 2019-06-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2020-11-17
• Last updated: 2023-11-24

Locations

1 site across 1 country: China