Non-small Cell Lung Cancer
Conditions
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.
Interventions
BIOLOGICALZG005 for Injection
intravenous infusion
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event (AE) | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | Up to 2 years |
Countries
China
Contacts
Primary ContactCong Zhang
Outcome results
None listed