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

Phase 1

Not yet recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Biological: ZG005 for Injection; Drug: Gecacitinib Hydrochloride Tablets

• Registration Number: NCT06903377
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Study Start: 2025-04
• Primary Completion: 2027-04
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part1-Group A	ZG005 for Injection	ZG005 20mg/kg IV Q3W+Gecacitinib 50mg po Bid
Part1-Group A	Gecacitinib Hydrochloride Tablets	ZG005 20mg/kg IV Q3W+Gecacitinib 50mg po Bid
Part1-Group B	ZG005 for Injection	ZG005 20mg/kg Q3W+Gecacitinib 100mg po Bid
Part1-Group B	Gecacitinib Hydrochloride Tablets	ZG005 20mg/kg Q3W+Gecacitinib 100mg po Bid

Primary Outcome Measures

Name	Time	Method
Adverse Event (AE)	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Up to 2 years

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China