Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer
A Multicenter, Open-label, Dose-Escalation and Dose-Expansion Phase I/II Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 nonsmall-cell-lung-cancer
Started May 2025
Shorter than P25 for phase_1 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2025
CompletedFirst Posted
Study publicly available on registry
March 30, 2025
CompletedStudy Start
First participant enrolled
May 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
January 5, 2026
December 1, 2025
1.9 years
March 24, 2025
December 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Event (AE)
Up to 2 years
Secondary Outcomes (1)
Objective response rate (ORR)
Up to 2 years
Study Arms (2)
Part1-Group A
EXPERIMENTALZG005 20mg/kg IV Q3W+Gecacitinib 50mg po Bid
Part1-Group B
EXPERIMENTALZG005 20mg/kg Q3W+Gecacitinib 100mg po Bid
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jason Wu
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2025
First Posted
March 30, 2025
Study Start
May 23, 2025
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
January 5, 2026
Record last verified: 2025-12