NCT04622072 is a Phase 1 clinical trial of XZP-5809-TT1 Tablet in Non Small Cell Lung Cancer, sponsored by Sihuan Pharmaceutical Holdings Group Ltd..

Who is sponsoring NCT04622072?

NCT04622072 is sponsored by Sihuan Pharmaceutical Holdings Group Ltd..

What drugs are being tested in NCT04622072?

Interventions in NCT04622072: XZP-5809-TT1 Tablet.

What condition does NCT04622072 study?

NCT04622072 studies Non Small Cell Lung Cancer.

Is NCT04622072 still recruiting?

NCT04622072 is currently terminated. Last updated 17 February 2023.

Last reviewed 2023-02-17 · How we verify

NCT04622072

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

XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer

Terminated Phase 1 Last updated 17 February 2023

What this trial tests

Phase 1 trial testing XZP-5809-TT1 Tablet in Non Small Cell Lung Cancer in 21 participants. Terminated before completion.

Timeline

2 November 2020

Primary endpoint
20 May 2021

27 April 2022

Quick facts

Lead sponsor	Sihuan Pharmaceutical Holdings Group Ltd.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	2 November 2020
Primary completion	20 May 2021
Estimated completion	27 April 2022
Sites	5 locations across China

Drugs / interventions tested

XZP-5809-TT1 Tablet — full drug profile →

Conditions studied

Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →

Sponsor

Sihuan Pharmaceutical Holdings Group Ltd. — full company profile →

Who can join

18 and older, any sex, with Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The trial is divided into two parts, one is dose escalation phase, the second one is dose expansion phase. For dose escalation phase, the main purpose is to evaluate safety and tolerability of XZP-5809-TT1 tablets after treatment with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) in patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer, and to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). For dose expansion phase, the main purpose is to evaluate Objective response rate (ORR) in patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Publications & conference data

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

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

Verify or expand the search:

Other recruiting trials for Non Small Cell Lung Cancer

Currently open trials in the same condition.

NCT06951646 — ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immuno · Phase 2 · recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
NCT07269782 — A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCL · Phase 2 · recruiting
NCT07306624 — Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer · Phase 2 · recruiting
NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting

Other Sihuan Pharmaceutical Holdings Group Ltd. trials

Trials by the same sponsor.

NCT04476394 — Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-20 mg/ · Phase 1 · unknown
NCT04444011 — Pharmacokinetic Interactions of Quadruple Therapy With Anaprazole/Amoxicilin/Clarithromycin/Bismuth · Phase 1 · unknown
NCT04215653 — A Phase 3 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers. · Phase 3 · unknown
NCT04200261 — Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects · Phase 1 · unknown
NCT03851432 — Janagliflozin Treat Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Metformin · Phase 3 · unknown

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 NCT04622072 (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 Sihuan Pharmaceutical Holdings Group Ltd.
Last refreshed: 17 February 2023

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/NCT04622072.

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