ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI

Inclusion Criteria

• •1. Participants must have a thorough understanding of this study and voluntarily sign an informed consent form (ICF);
• •2. Age between 18 and 80 years, any gender;
• •3. Histologically or cytologically confirmed stage III-IV non-small cell lung cancer (NSCLC);
• •4. Previous treated with first-line immunotherapy (immunotherapeutic agents include currently marketed anti-PD-L1 or anti-PD-1 monoclonal antibodies: pembrolizumab, nivolumab, atezolizumab, durvalumab, tislelizumab, toripalimab, sintilimab, camrelizumab, etc.; investigational drugs not yet marketed need discussion with the study team prior to enrollment; with or without platinum-based doublet chemotherapy) for at least 35 cycles or disease stability confirmed by imaging assessment for at least 2 years, and disease progression;
• •5. Measurable disease (at least 1 lesion) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
• •6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
• •7. Adequate organ function:
• •Hematology: Absolute neutrophil count (ANC) ≥1500/μL; Platelets ≥100000/μL; Hemoglobin ≥9.0g/dL; Renal: Serum creatinine ≤1.5×ULN or calculated creatinine clearance (CrCl) ≥60 mL/min (using Cock-Gault formula); Hepatic: Total bilirubin ≤1.5 ×ULN or, for subjects with total bilirubin levels \>1.5×ULN, direct bilirubin within normal limits; AST (SGOT) and ALT (SGPT) ≤2.5×ULN; Coagulation: International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (APTT) ≤1.5×ULN;
• •8. Subjects must be willing and able to comply with study visits, treatment plans, laboratory tests, and other study procedures;
• •9. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use highly effective contraception during the study and for 180 days after the last dose of the study drug.