Viewing Study NCT05204628



Ignite Creation Date: 2024-05-06 @ 5:08 PM
Last Modification Date: 2024-10-26 @ 2:22 PM
Study NCT ID: NCT05204628
Status: NOT_YET_RECRUITING
Last Update Posted: 2022-01-24
First Post: 2021-12-20

Brief Title: A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib
Sponsor: Xuanzhu Biopharmaceutical Co Ltd
Organization: Xuanzhu Biopharmaceutical Co Ltd

Study Overview

Official Title: 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: NOT_YET_RECRUITING
Status Verified Date: 2021-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 11 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 11 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 v11 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None