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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
115
PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy
Incidence and severity of adverse events (AEs)
Incidence, severity and clinically significant abnormal laboratory findings of treatment related AEs.
Time frame: 3 months
Disease Free Surviva Percentage(DFS%)
Disease Free Survival (DFS): The time from the first infusion day of PANK - 003 cell injection in subjects to the recurrence of the tumor (including local recurrence, regional recurrence, or distant metastasis) or death due to any cause. Disease Free Surviva Percentage(DFS%): It refers to the proportion of subjects who have not experienced tumor recurrence or death at a specific follow-up time point, typically expressed as a percentage. Its core lies in using survival analysis methods, combined with the follow-up data of subjects, to estimate the disease-free survival probabilities at different time points.
Time frame: 1 year
Disease Free Survival (DFS)
Disease Free Survival (DFS): The time from the first infusion day of PANK - 003 cell injection in subjects to the recurrence of the tumor (including local recurrence, regional recurrence, or distant metastasis) or death due to any cause.
Time frame: 1 year
Overall Survival (OS)
Overall Survival (OS):The time from the date of first administration of PANK-003 cell injection to deathfrom any cause.
Time frame: 1 year
Tumor Recurrence Rate (TRR)
Tumor Recurrence Rate (TRR): The proportion of subjects who experience tumor recurrence from the first infusion day of PANK-003 to the end of follow-up.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.