Viewing Study NCT05482087



Ignite Creation Date: 2024-05-06 @ 5:56 PM
Last Modification Date: 2024-10-26 @ 2:38 PM
Study NCT ID: NCT05482087
Status: NOT_YET_RECRUITING
Last Update Posted: 2022-08-01
First Post: 2022-07-21

Brief Title: A Study of XZP-3621 in Chinese Patients With ALK Positive NSCLC
Sponsor: Xuanzhu Biopharmaceutical Co Ltd
Organization: Xuanzhu Biopharmaceutical Co Ltd

Study Overview

Official Title: A Phase II Multi-center Open-label Single-Arm Study to Evaluate the Efficacy and Safety of Oral XZP-3621 Treatment for Chinese Patients With ALK-Positive Non-Small Cell Lung Cancer
Status: NOT_YET_RECRUITING
Status Verified Date: 2022-07
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 was a single-arm open-label multicenter phase II study to evaluate the efficacy and safety of the ALK inhibitor XZP-3621 when used as single agent in patients with ALK-rearranged stage IIIB IIIC or IV NSCLC previously treated with other ALK inhibitors or non-previously treated
Detailed Description: This is a Phase 2 China only multi center open label three cohorts study in ALK positive locally advanced or metastatic NSCLC patients will be enrolled to receive XZP-3621 monotherapy

in Cohort 1 Treatment-Naive with any ALK inhibitor in Cohort 2 Disease progression after crizotinib as the only ALK inhibitor in Cohort 3 Disease progression after other ALK inhibitorsincluding or not including crizotinib previously treated

The patients will receive XZP-3621 at 500 mg orally once daily QD taken with foodPatients will be treated until disease progression unacceptable toxicity withdrawal of consent or death whichever occurred first 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