Abstract
OBJECTIVES: To evaluate the efficacy, safety, and immunomodulatory effects of thymalfasin in combination with different immune checkpoint inhibitor (ICI)-based regimens in patients with advanced driver gene-negative non-small cell lung cancer(NSCLC). METHODOLOGY: A retrospective analysis was conducted on 120 patients with advanced NSCLC treated at Shijiazhuang People's Hospital between January 2021 to December 2024. Patients were assigned to three groups: Group-A(n= 42), platinum-based doublet chemotherapy + ICIs + thymalfasin; Group-B(n= 44), single-agent chemotherapy + ICIs + thymalfasin; Group-C(n= 34), ICIs + thymalfasin. Assessed objective response rate(ORR), disease control rate(DCR), progression-free survival(PFS), overall survival (OS), adverse events(AEs), immunological indices, and quality of life score and 6-min walk distance [6MWD]). RESULTS: ORR and DCR did not differ significantly among groups(P> 0.05, respectively). Median PFS and OS were significantly longer in chemotherapy-containing regimens(Groups-A and B) compared with Group-C(P <0.05, respectively), whereas no significant differences were observed between Groups-A and B. The incidence of AEs, including myelosuppression and gastrointestinal reactions, was comparable across groups(all P> 0.05). After treatment, all groups demonstrated significant improvements in immunological function(all P< 0.05), with Group-A showing the most pronounced increases in CD4(+), IgG, and IgA levels compared with Group-C (P< 0.05, respectively). Improvements in FACT-L scores were most evident in Group-A (P< 0.05), and declines in 6MWD were smallest in this group(P< 0.05). CONCLUSION: Thymalfasin combined with ICIs and chemotherapy, particularly platinum-based doublet regimens, may significantly prolong survival, enhance immune function, and improve quality of life in patients with advanced NSCLC, without increasing treatment-related toxicity.