Overview

A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib

Status:
Not yet recruiting
Trial end date:
2025-07-01
Target enrollment:
Participant gender:
Summary
This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of XZP-3621 versus crizotinib and to evaluate the pharmacokinetics of XZP-3621 in Chinese participants with treatment-naive ALK-positive advanced NSCLC. Participants will be randomized 1:1 into one of the two treatment groups to receive either XZP-3621 (500 milligrams [mg] once daily [QD]) or crizotinib (250 mg BID) orally, respectively.
Phase:
Phase 3
Details
Lead Sponsor:
Xuanzhu Biopharmaceutical Co., Ltd.
Treatments:
Crizotinib