NCT05482087

A Study of XZP-3621 in Chinese Patients With ALK Positive NSCLC

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 inhibitors,including or not including crizotinib previously treated. The patients will receive XZP-3621 at 500 mg orally once daily (QD), taken with food.Patients will be treated until disease progression, unacceptable toxicity, withdrawal of consent, or death, whichever occurred first. 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

• ALK-positive NSCLC

Interventions

Type	Name	Description
DRUG	XZP-3621	ALK inhibitor-treated ALK-positive NSCLC treatment

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-05-07
• Completion: 2025-07-01
• First posted: 2022-08-01
• Last updated: 2022-08-01

Locations

1 site across 1 country: China