Zhou, CaicunHu, YanpingArkania, EkaterineKilickap, SaadettinYing, KejingXu, FeiWu, Lin2024-05-192024-05-1920241535-61081878-3686https://doi.org10.1016/j.ccell.2023.12.004https://hdl.handle.net/20.500.12713/5720Combining immunotherapy with chemotherapy can provide improved survival in advanced squamous nonsmall -cell lung cancer (NSCLC) patients without targetable gene alterations. 537 previously untreated patients with stage IIIB/IIIC or IV squamous NSCLC without targetable gene alterations were enrolled and randomized (2:1) to receive serplulimab 4.5 mg/kg or placebo, both in combination with nab-paclitaxel and carboplatin, intravenously in 3 -week cycles. The primary endpoint of progression -free survival (PFS) was met at the first interim analysis. At the second interim analysis, PFS benefit was maintained in serplulimab-chemotherapy group (hazard ratio [HR] 0.53, 95% confidence interval [CI] 0.42-0.67). At the final analysis, serplulimab-chemotherapy significantly improved median OS compared to placebo -chemotherapy (HR 0.73, 95% CI 0.58-0.93; p = 0.010). Grade R3 serplulimab or placebo -related adverse events occurred in 126 (35.2%) and 58 (32.4%) patients, respectively. Our results demonstrate that adding serplulimab to chemotherapy significantly improves survival in advanced squamous NSCLC patients, with manageable safety.eninfo:eu-repo/semantics/closedAccessNab-PaclitaxelGemcitabineCarboplatinPlaceboTrialArticle42238181795WOS:001183731600001N/A10.1016/j.ccell.2023.12.004