This is a single-arm study designed to evaluate the safety and efficacy of TILs combined with third-generation EGFR-TKIs therapy for patients with EGFR-mutant NSCLC resistant to TKI.
This study is an open-label, single-arm, prospective clinical trial. 50 subjects with advanced EGFR-TKI-resistant NSCLC, including those complicated with malignant pleural effusion, will be enrolled and receive TILs infusion combined with third-generation EGFR-TKIs. Adverse reactions, therapeutic efficacy and other relevant indicators will be closely observed and followed up to systematically evaluate the safety and efficacy of this combined regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Experimental: Surgically collect fresh tumor tissue or malignant pleural effusion to isolate immune cells, and prepare TILs Infusion. Trial product: TILs Injection. Administration route: Intravenous Infusion
According to the incidence of treatment-related adverse events (AEs) to evaluate the safety of Tumor-Infiltrating Lymphocytes (TILs) combined with third-Generation EGFR-TKI therapy for TKI-Resistant advanced Non-Small Cell Lung Cancer (NSCLC)
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0.
Time frame: up to three years
According to the subgroup analysis of TILs in patients with TKI-Resistant advanced NSCLC to analyze the correlation between TILs and disease prognosis.
TILs subgroup analysis Description: Composition, phenotype, and function of TILs
Time frame: Up to three months
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