Who is sponsoring NCT05055232?

NCT05055232 is sponsored by Xuanzhu Biopharmaceutical Co., Ltd..

What drugs are being tested in NCT05055232?

Interventions in NCT05055232: XZP-3621.

What condition does NCT05055232 study?

NCT05055232 studies ROS1 Rearrangement Non-small Cell Lung Cancer, ALK Rearrangement Non-small Cell Lung Cancer.

Is NCT05055232 still recruiting?

NCT05055232 is currently completed. Last updated 24 July 2025.

Last reviewed 2025-07-24 · How we verify

NCT05055232

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 24 July 2025

What this trial tests

Phase 1 trial testing XZP-3621 in ROS1 Rearrangement Non-small Cell Lung Cancer in 114 participants. Completed in 15 August 2023.

Timeline

12 March 2019

Primary endpoint
15 August 2023

15 August 2023

Quick facts

Lead sponsor	Xuanzhu Biopharmaceutical Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	114
Start date	12 March 2019
Primary completion	15 August 2023
Estimated completion	15 August 2023
Sites	1 location across China

Drugs / interventions tested

XZP-3621 — full drug profile →

Conditions studied

ROS1 Rearrangement Non-small Cell Lung Cancer — all drugs for ROS1 Rearrangement Non-small Cell Lung Cancer →
ALK Rearrangement Non-small Cell Lung Cancer — all drugs for ALK Rearrangement Non-small Cell Lung Cancer →

Sponsor

Xuanzhu Biopharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with ROS1 Rearrangement Non-small Cell Lung Cancer or ALK Rearrangement Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, open-label, dose escalation, and expansion human clinical study to observe the safety, tolerability, pharmacokinetics, and pharmacodynamics of XZP-3621 in single and multiple oral administrations in advanced NSCLC subjects with ALK rearrangement or ROS1 rearrangement, and to initially explore the efficacy of XZP-3621.The study was divided into two parts: dose escalation and dose expansion.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting ALK Rearrangements in NSCLC: Current State of the Art.
Peng L, Zhu L, Sun Y, Stebbing J, et al · · 2022 · cited 39× · PMID 35463328 · DOI 10.3389/fonc.2022.863461
Molecular pathways, resistance mechanisms and targeted interventions in non-small-cell lung cancer.
Wang Z, Xing Y, Li B, Li X, et al · · 2022 · cited 31× · PMID 36508072 · DOI 10.1186/s43556-022-00107-x
Targeted therapies in non-small cell lung cancer: present and future.
McLaughlin J, Berkman J, Nana-Sinkam P. · · 2023 · cited 11× · PMID 37675274 · DOI 10.12703/r/12-22
Sustained Improvement in the Management of Patients with Non-Small-Cell Lung Cancer (NSCLC) Harboring ALK Translocation: Where Are We Running?
Spitaleri G, Trillo Aliaga P, Attili I, Del Signore E, et al · · 2023 · cited 8× · PMID 37232842 · DOI 10.3390/curroncol30050384
Preclinical characterization and first-in-human, phase I trial of the novel ALK inhibitor dirozalkib in advanced non-small cell lung cancer.
Ai X, Guo R, Zhang L, Fang J, et al · · 2026 · PMID 41539180 · DOI 10.1016/j.ejca.2026.116221

Verify or expand the search:

Other trials of XZP-3621

Trials testing the same drug.

NCT05204628 — A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib · Phase 3 · unknown
NCT05034120 — Food Effect and Mass Balance Study of XZP-3621 Tablets · Phase 1 · completed

Other Xuanzhu Biopharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07345689 — A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations · Phase 4 · not yet recruiting
NCT07330531 — Drug-drug Interaction Study of Rifampin and Anaprazole Sodium · Phase 4 · not yet recruiting
NCT05586568 — Drug-drug Interaction Study of XZP-3621 Tablet · Phase 1 · unknown
NCT05478109 — A Clinical Trial of XZP-3287 for Material Balance · Phase 1 · unknown
NCT05257395 — A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer · Phase 3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05055232 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Xuanzhu Biopharmaceutical Co., Ltd.
Last refreshed: 24 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05055232.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing