This prospective Phase II study aims to evaluate the preliminary efficacy and safety of WAST cells combined with docetaxel as second-line therapy in patients with advanced NSCLC resistant to PD-1 inhibitors.
At screening, patients must meet the following diagnostic and treatment criteria: 1) Histologically or cytologically confirmed NSCLC, 2) Advanced NSCLC as determined by imaging according to AJCC V8, 3) Disease progression after first-line treatment with a PD-1 inhibitor; Expected survival time greater than 3 months;
At screening, measurable target lesions on imaging with the longest diameter greater than 1.0 cm;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening;
Women of childbearing potential must have a negative urine pregnancy test, and any male or female patient capable of having children must agree to use effective contraception throughout the study and for at least 1 year after the last dose of study treatment.
Patients with symptomatic central nervous system (CNS) metastases at screening (patients with asymptomatic CNS metastases, or those who have been treated locally and are stable without symptoms for 4 weeks, are eligible);
History of CNS disorders prior to screening, such as epilepsy, cerebrovascular ischemia/hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, organic brain syndromes, psychiatric disorders, or any autoimmune diseases affecting the CNS;
Received immunotherapy, targeted therapy, chemotherapy, or radiotherapy within 4 weeks before screening, and deemed unsuitable for enrollment by the investigator;
Discontinued systemic corticosteroid therapy less than 72 hours before cell infusion; however, physiological replacement doses of steroids (e.g., prednisone <10 mg/day or equivalent) are allowed;
Single group
Whole Agonist-Stimulated T (WAST) cells injection
Biological/VaccineWAST cells (≥4.0 × 10⁹ cells), intravenous infusion, d14, Q3W for 4 cycles.
Docetaxel
Drug75 mg/m², intravenous infusion, day 1, Q3W.
Objective Response Rate (ORR)
ORR was defined as the percentage of patients with a confirmed complete (CR) or partial response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator.
Progression-free survival (PFS)
PFS was defined as the time from the initial treatment to the first occurrence of disease progression or all-cause death (whichever occurs first) assessed by the investigator according to RECIST v1.1.
Overall Survival (OS)
OS was defined as the time from the initial treatment until the date of death due to any cause.
Disease Control Rate (DCR)
DCR was defined as the proportion of patients with the best overall response of CR, PR, and stable disease (SD) as determined by the investigator according to RECIST 1.1.
Duration of response (DOR)
DOR was defined as first documented evidence of a CR or PR until PD or death as determined by the investigator according to RECIST v1.1.
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