PANK-003 Cell Injection Combined With Standard Adjuvant Chemotherapy After Surgery in Patients With Stage IIIA NSCLC
brief summary
A Single-center, Single-arm Clinical Trial on the Safety and Efficacy of PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Stage IIIA Non-Small Cell Lung Cancer
detailed description
This study is a single-center, single-arm, open-label, single-dose administration dose-finding study, which aims to evaluate the safety and efficacy characteristics of PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Stage IIIA Non-Small Cell Lung Cancer.
The study includes a screening period, a treatment period, and an observation and follow-up period.
The main objectives :
To evaluate the safety and efficacy of multiple injections of PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy in the treatment of patients with Stage IIIA Non-Small Cell Lung Cancer.
Primary Endpoints： Safety Endpoints: Incidence and severity of investigator-assessed adverse events (AEs), and clinically significant abnormal laboratory findings.
Efficacy Endpoint: 1-year DFS% assessed by the Independent Radiology Review Committee according to RECIST 1.1 criteria.
official title
A Single-center, Single-arm Exploratory Clinical Trial on the Safety and Efficacy of PANK-003 Cell Injection Combined With Standard Adjuvant Chemotherapy After Surgery in Patients With Stage IIIA Non-Small Cell Lung Cancer