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

Phase 2RecruitingNCT06903377

Suzhou Zelgen Biopharmaceuticals Co.,Ltd50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small Cell Lung Cancer

Interventions

ZG005 for InjectionBIOLOGICAL

intravenous infusion

Gecacitinib Hydrochloride TabletsDRUG

Oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Adverse Event (AE)

Time frame: Up to 2 years

Secondary Outcomes

Objective response rate (ORR)

Time frame: Up to 2 years

Central Contacts

Cong Zhang

CONTACT

17602176888 zhangc@zelgen.com

Data from ClinicalTrials.gov

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