我们进行了一项 3 期临床试验，以比较铂类联合化疗联合纳武单抗加伊匹单抗与铂类联合化疗联合帕博利珠单抗治疗既往未经治疗的晚期 NSCLC 患者的疗效。该试验在对 295 名患者进行治疗后提前终止，因为纳武单抗联合伊匹单抗治疗组中与治疗相关的死亡比例很高，其中 3 例是由于细胞因子释放综合征 (CRS) 所致。此外，我们还遇到了两例得到有效治疗的 CRS 病例，纳武单抗加伊匹单抗组的 148 名患者中共有 5 例（3.4%）。我们在这里提供这五个案例的详细信息。尽管患者背景和 CRS 发病时间不同，但所有 5 例病例在 CRS 出现之前均观察到发热。因此，肿瘤学家应该意识到，纳武单抗加伊匹单抗治疗期间患者出现发热可能预示着 CRS 的发生。版权所有 © 2023 国际肺癌研究协会。由爱思唯尔公司出版。保留所有权利。

We conducted a phase 3 clinical trial to compare the efficacy of platinum-based combination chemotherapy together with nivolumab plus ipilimumab relative to that of platinum-based combination chemotherapy together with pembrolizumab in previously untreated patients with advanced NSCLC. The trial was terminated prematurely after treatment of 295 patients because of a high proportion of treatment-related deaths, three of which were due to cytokine release syndrome (CRS), in the nivolumab plus ipilimumab treatment arm. In addition, we encountered two cases of CRS that were effectively managed, for a total of five cases (3.4%) among the 148 patients in the nivolumab plus ipilimumab arm. We here provide details of these five cases. Although patient background and timing of CRS onset differed, fever was observed before the emergence of CRS in all five cases. Oncologists should thus be aware that the development of fever during treatment of patients with nivolumab plus ipilimumab may herald the onset of CRS.Copyright © 2023 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.