Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer

NCT06903377 · tracked via the Priya Life Science China tracker

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Phase

Phase 1/2

Started

2025-05-23

Last updated

2026-01-05

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

ZG005 for InjectionGecacitinib Hydrochloride Tablets

ZG005 for Injection: intravenous infusion

Gecacitinib Hydrochloride Tablets: Oral

Study summary

This is a multicenter Phase I/II study for patients with advanced non-small cell lung cancer who have failed PD-1/L1 therapy, aiming to evaluate the safety of ZG005 in combination with Gecacitinib in this population, as well as the preliminary efficacy of this combination regimen.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Fully understand this study and voluntarily sign the ICF. * Age 18-75 years, no gender restriction. * Patients with locally advanced or recurrent/metastatic squamous and/or non-squamous non-small cell lung cancer confirmed by histology/cytology, unsuitable for radical therapy. Exclusion Criteria: * Medical history, CT scan, or MRI indicates the presence of CNS metastases. * Other malignancies within 5 years. * Any other reason deeming the participant unsuitable for the study, as judged by the investigator.

Primary outcome measure(s)

Adverse Event (AE) — Up to 2 years

Trial sites (1)

Facility	City	Region	Status
Shanghai Chest Hospital	Shanghai	Shanghai Municipality	Recruiting

More Suzhou Zelgen Biopharmaceuticals Co.,Ltd trials in China

Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma Recruiting

Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer Recruiting

Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma Recruiting

Study of ZGGS18 in Patients With Advanced Solid Tumors Recruiting

A Pharmacokinetic Study of Gecacitinib Hydrochloride Tablets in Healthy Adult Participants. Active, not recruiting

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A Study of GNC-077 in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer and Other Solid Tumors Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06903377 on ClinicalTrials.gov ↗ ← All trials in China