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

December 30, 2025 updated by: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
          • Xinghao Ai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part1-Group A
ZG005 20mg/kg IV Q3W+Gecacitinib 50mg po Bid
Biological: ZG005 for Injection
intravenous infusion
Other Names:
  • ZG005
Drug: Gecacitinib Hydrochloride Tablets
Oral
Other Names:
  • Gecacitinib
Experimental: Part1-Group B
ZG005 20mg/kg Q3W+Gecacitinib 100mg po Bid
Biological: ZG005 for Injection
intravenous infusion
Other Names:
  • ZG005
Drug: Gecacitinib Hydrochloride Tablets
Oral
Other Names:
  • Gecacitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Event (AE)
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

  • Study Chair: Jason Wu, Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZG005-JAK-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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