XZP-3621

DRUG4 trials

Sponsors

Xuanzhu Biopharmaceutical Co., Ltd.

Conditions

ALK Rearrangement Non-small Cell Lung CancerALK-positive NSCLCHealthyNon-small Cell Lung CancerROS1 Rearrangement Non-small Cell Lung Cancer

Phase 1

Food Effect and Mass Balance Study of XZP-3621 Tablets

CompletedNCT05034120

Xuanzhu Biopharmaceutical Co., Ltd.Healthy

Start: 2021-12-23End: 2022-03-30Updated: 2025-05-25

A Phase I Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lung Cancer

CompletedNCT05055232

Xuanzhu Biopharmaceutical Co., Ltd.ALK Rearrangement Non-small Cell Lung Cancer, ROS1 Rearrangement Non-small Cell Lung Cancer

Start: 2019-03-12End: 2023-08-15Updated: 2025-07-24

Phase 2

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

Xuanzhu Biopharmaceutical Co., Ltd.ALK-positive NSCLC

Start: 2022-09-30End: 2025-07-01Target: 190Updated: 2022-08-01

Phase 3

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

Xuanzhu Biopharmaceutical Co., Ltd.Non-small Cell Lung Cancer

Start: 2022-02-07End: 2025-07-01Target: 238Updated: 2022-01-24

Related Papers

Abstract CT299: Dirozalkib versus crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC): Results from the multicenter, randomized, open-label phase 3 trial

Cancer Research2026-04-17

Abstract CT243: Dirozalkib in patients with advanced ALK-positive non-small cell lung cancer (NSCLC): Results from a phase 2 study

Cancer Research2026-04-17

Preclinical characterization and first-in-human, phase I trial of the novel ALK inhibitor dirozalkib in advanced non-small cell lung cancer.

2026-01-07