SynthesisFrontiers in immunology2026
Efficacy of PD-1/PD-L1 plus CTLA-4 inhibitors in advanced/metastatic NSCLC: a meta-analysis based on RCTs.
Synthesis in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors.
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Abstract
Background: Dual immune checkpoint inhibitor (ICI) therapy (PD-1/PD-L1+CTLA-4 inhibitors) has emerged as a promising strategy, but its efficacy and optimal patient selection remain uncertain. This meta-analysis aimed to evaluate the efficacy of dual ICI therapy in advanced/metastatic non-small cell lung cancer (NSCLC) based on randomized controlled trials (RCTs). Methods: We systematically searched Cochrane Library, Embase, Web of Science, and PubMed from inception to August 2025 for RCTs comparing dual ICI therapy (PD-1/PD-L1+CTLA-4 inhibitors) versus control treatments in advanced/metastatic NSCLC. The primary outcome was overall survival (OS), and the secondary outcome was progression-free survival (PFS). Results: Ten RCTs comprising 6,369 patients were included. The OS (HR = 0.84, 95%CI 0.76-0.92, p=0.003) and PFS (HR = 0.78, 95%CI 0.68-0.89, p=0.002) of patients who received dual ICI treatment were significantly better than those in the control group. Subgroup analyses of the OS revealed significant benefits, including: squamous, non-squamous, PD-1 inhibitor, PD-L1 inhibitor, bone metastases, without bone metastases, male, age<65, ECOG = 0, Asian, PD-L1 TPS<1%, PD-L1 TPS≥50%, with high TMB (TMB≥10 or TMB≥20), smokers, brain metastases, without liver metastases, and when the control group received chemotherapy, placebo, first-line (1L) or non 1L (all p<0.05). Conversely, no significant benefit was observed in patients aged≥65, low TMB (TMB<10 or TMB<20), non-smokers, without brain metastases, or when the control group received monotherapy immunotherapy (all p>0.05 and P_interaction <0.05). Conclusion: Dual ICI therapy with PD-1/PD-L1 plus CTLA-4 inhibitors improves prognosis in advanced/metastatic NSCLC, with efficacy difference across subgroups. TMB may serve as a complementary predictive biomarker for dual immunotherapy. Systematic review registration: PROSPERO, identifier: CRD420251147483.
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