RGL-270 + ICI in Advanced NSCLC

This is a single-center, open-label, investigator-initiated clinical trial. It aims to evaluate the safety and tolerability of RGL-270 in combination with a PD-1/PD-L1 inhibitor, to assess immunogenicity, preliminary efficacy, and exploratory biomarkers and to observe the safety and effectiveness of PD-1/PD-L1 inhibitor monotherapy in advanced NSCLC subjects through a real-world observational cohort.

1. Subjects capable of understanding/compliance with study procedures and voluntarily signing informed consent. 2. Age ≥18, any gender. 3. Histologically/cytologically confirmed NSCLC. 5.ECOG performance status 0 or 1. 6.Life expectancy ≥6 months. 7\. Subject must have at least one measurable tumor lesion by RECIST 1.1 criteria at baseline prior to first-line treatment. Note: Previously irradiated lesions not eligible as target lesions unless documented progression post-radiation. 8\. Subjects with asymptomatic central nervous system (CNS) metastases (excluding meningeal or cerebrospinal membrane metastases) are allowed. For symptomatic CNS metastases, the condition must be stable after local treatment and no steroid or anticonvulsant treatment is required at least 7 days before enrollment (antiepileptic drugs are allowed). 9.Willing to provide sufficient fresh tumor tissue or archival specimens for genomic profiling and neoantigen analysis (fresh tissue preferred). 10.Willing to provide blood samples for immunogenicity/biomarker assessments at all timepoints. Pre-biopsy samples require no transfusion/blood products/G-CSF within 10 days. 11.Adequate organ function (no blood products/growth factors within 10 days prior to testing): Hematology: ANC ≥1.5×10⁹/L, LYM ≥0.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90g/L Biochemistry: TBIL ≤1.5×ULN, ALT/AST ≤2.5×ULN, ALB ≥30g/L, Scr ≤1.5×ULN Coagulation: INR ≤1.5, APTT ≤1.5×ULN Cardiac: LVEF ≥50% ECG: QTcF \