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

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Gecacitinib Hydrochloride Tablets; Biological: ZG005 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06903377

ZG005-JAK-001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Part1-Group A

Experimental group

Description:

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

Treatment:

Biological: ZG005 for Injection

Drug: Gecacitinib Hydrochloride Tablets

Part1-Group B

Experimental group

Description:

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

Treatment:

Biological: ZG005 for Injection

Drug: Gecacitinib Hydrochloride Tablets