Objective To systematically evaluate the efficacy and safety of immune checkpoint inhibitors (ICI) combined with tyrosine kinase inhibitors (TKI) in patients with extensive-stage small cell lung cancer (ES-SCLC).

Methods PubMed, Embase, Cochrane Library, CNKI, VIP, and Wanfang Data databases were searched from their inception to December 1, 2025. Clinical studies on ICI combined with TKI in the treatment of ES-SCLC were collected. After two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies, a Meta-analysis was performed using R 4.4.2 software.

Results A total of 12 studies were included. The Meta-analysis results showed that compared with monotherapy, combination therapy significantly prolonged progression-free survival (PFS) [HR=0.75, 95%CI (0.70,0.81), P<0.001] and overall survival (OS) [HR=0.60, 95%CI(0.56,0.65), P<0.001] in patients. Furthermore, the objective response rate (ORR) [OR=2.46, 95%CI (1.57, 3.86), P<0.001] and disease control rate (DCR) [OR=3.79, 95%CI (2.56, 5.60), P<0.001] in the combination therapy group were significantly higher than those in the monotherapy group. In terms of safety, there were no statistically significant differences between the two groups in the incidence of hypertension [OR = 1.37, 95%CI (0.58, 3.24), P=0.47], myelosuppression [OR=0.55, 95%CI (0.10, 3.15), P=0.38], hand-foot syndrome [OR=1.59, 95%CI (0.62, 4.10), P=0.34], and pneumonia [OR=2.45, 95%CI (0.82, 7.30), P=0.11].

Conclusion Current evidence indicates that ICI combined with TKI can significantly improve PFS, OS, ORR, and DCR in patients with ES-SCLC. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusion.

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