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

NCT ID: NCT06903377

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2027-05-31

Brief Summary

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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

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part1-Group A

ZG005 20mg/kg IV Q3W+Gecacitinib 50mg po Bid

Group Type EXPERIMENTAL

ZG005 for Injection

Intervention Type BIOLOGICAL

intravenous infusion

Gecacitinib Hydrochloride Tablets

Intervention Type DRUG

Oral

Part1-Group B

ZG005 20mg/kg Q3W+Gecacitinib 100mg po Bid

Group Type EXPERIMENTAL

ZG005 for Injection

Intervention Type BIOLOGICAL

intravenous infusion

Gecacitinib Hydrochloride Tablets

Intervention Type DRUG

Oral

Interventions

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ZG005 for Injection

intravenous infusion

Intervention Type BIOLOGICAL

Gecacitinib Hydrochloride Tablets

Oral

Intervention Type DRUG

Other Intervention Names

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ZG005 Gecacitinib

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Wu

Role: STUDY_CHAIR

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Locations

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Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Cong Zhang

Role: CONTACT

Phone: 17602176888

Email: [email protected]

Facility Contacts

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Xinghao Ai

Role: primary

Other Identifiers

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ZG005-JAK-001

Identifier Type: -

Identifier Source: org_study_id