NCT05204628

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

Randomized Multicenter Phase III Open-Label Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib in Chinese Patients With Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, active controlled, multicenter Phase III open-label study in patients with treatment-naive ALK-positive advanced NSCLC. Patients will be randomized 1:1 into one of the two treatment arms to receive either XZP-3621 or crizotinib. The primary endpoint of the study is investigator-assessed PFS. Central randomization will be performed via a web-based response system using the following stratification factors: chemotherapy (yes vs. no) and CNS metastases at baseline (yes vs. no). The experimental arm will receive XZP-3621 at 500 mg orally once daily (QD), taken with food. The control arm will receive crizotinib at 250 mg orally BID, taken with or without food. Patients will be treated until disease progression, unacceptable toxicity, withdrawal of consent, or death. After disease progression (as per RECIST v1.1), patients should discontinue the study medication. After disease progression, patients will be treated at the discretion of the investigator according to local practice. Information regarding the nature and the duration of subsequent therapies will be collected.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	XZP-3621	XZP-3621 tablets will be administered orally at a dose of 500 mg QD until disease progression, unacceptable toxicity withdrawal of consent, or death, whichever occurred first.
DRUG	Crizotinib	Crizotinib capsules will be administered orally at a dose of 250 mg BID until disease progression, unacceptable toxicity withdrawal of consent, or death, whichever occurred first.

Timeline

• Start date: 2022-02-07
• Primary completion: 2025-05-07
• Completion: 2025-07-01
• First posted: 2022-01-24
• Last updated: 2022-01-24

Locations

1 site across 1 country: China