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

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.

Timeline

Start

2022-02-07

Primary completion

2025-05-07

Completion

2025-07-01

Drugs

Indications