NCT05482087 is a Phase 2 clinical trial of XZP-3621 in ALK-positive NSCLC, sponsored by Xuanzhu Biopharmaceutical Co., Ltd..

Who is sponsoring NCT05482087?

NCT05482087 is sponsored by Xuanzhu Biopharmaceutical Co., Ltd..

What drugs are being tested in NCT05482087?

Interventions in NCT05482087: XZP-3621.

What condition does NCT05482087 study?

NCT05482087 studies ALK-positive NSCLC.

Is NCT05482087 still recruiting?

NCT05482087 is currently status unknown. Last updated 29 July 2022.

Last reviewed 2022-07-29 · How we verify

NCT05482087

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

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 2 Last updated 29 July 2022

What this trial tests

Phase 2 trial testing XZP-3621 in ALK-positive NSCLC in 190 participants. Status unknown.

Timeline

1 September 2022

Primary endpoint
7 May 2025

1 July 2025

Quick facts

Lead sponsor	Xuanzhu Biopharmaceutical Co., Ltd.
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	190
Start date	1 September 2022
Primary completion	7 May 2025
Estimated completion	1 July 2025
Sites	1 location across China

Drugs / interventions tested

XZP-3621 — full drug profile →

Conditions studied

ALK-positive NSCLC — all drugs for ALK-positive NSCLC →

Sponsor

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

Who can join

Adults 18 to 75, any sex, with ALK-positive NSCLC. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Overall Response Rate(ORR)
Time frame: From Cycle 1 Day 1 to documented progression of disease by Investigator (up to 20 months)[Note:Each cycle is 28 days]..
ORR was defined as the proportion of patients with a best overall response defined as Complete Response (CR) or Partial Response (PR) as evaluated by investigator assessment per RECIST 1.1.CR was defined as the disappearance of all target lesions. PR was defined as a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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

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
NCT05055232 — A Phase I Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lung Cancer · Phase 1 · completed

Other recruiting trials for ALK-positive NSCLC

Currently open trials in the same condition.

NCT07491497 — A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC · Phase 1, PHASE2 · recruiting
NCT02393625 — Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lun · Phase 1 · active not recruiting

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 NCT05482087 (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: 29 July 2022

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/NCT05482087.

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