The current standard second-line treatment is immune checkpoint inhibitors monotherapy for nonsmall cell lung cancer (NSCLC) patients. The objective of this phase 2 study was to evaluate the efficacy and safety of nivolumab plus docetaxel compared with nivolumab monotherapy for second-line therapy in immunotherapy-naive patients with advanced NSCLC. Progression-free survival (PFS) was the primary endpoint of this phase 2 study. Patients were randomized to receive nivolumab plus docetaxel or nivolumab monotherapy. From July 2019 to June 2022, a total of 22 patients were recruited, with significantly longer median PFS observed in the nivolumab plus docetaxel group (4.0 months) compared to the nivolumab group (2.0 months), P = 0.0019. The study was closed in June 2022 due to slow recruitment. The objective response rate was 10.0% [95% confidence interval (CI), 0-28.6] in the nivolumab group and 25% (95% CI, 0.5-49.5) in the nivolumab + docetaxel group ( P = 0.346). Disease control was significantly higher in the nivolumab plus docetaxel arm (40.0% versus 83.3%, P = 0.035). There was also an improvement in overall survival (OS) in the nivolumab + docetaxel arm, but this was not statistically significant (10.0 months versus 7.2 months, P = 0.129). The addition of docetaxel to nivolumab was well-tolerated, with adverse events more common in the combination group. Despite the small sample size, the results suggest that the addition of docetaxel to nivolumab may be a promising treatment option for NSCLC patients progressing on platinum-based chemotherapy, with trends towards improved OS observed.

中文翻译：

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纳武单抗联合多西他赛与纳武单抗治疗既往接受过治疗的非小细胞肺癌患者：一项 2 期研究。

目前非小细胞肺癌（NSCLC）患者的标准二线治疗是免疫检查点抑制剂单药治疗。这项 2 期研究的目的是评估纳武单抗联合多西紫杉醇与纳武单抗单药治疗相比，对于未接受过免疫治疗的晚期 NSCLC 患者的二线治疗的疗效和安全性。无进展生存期 (PFS) 是这项 2 期研究的主要终点。患者被随机接受纳武单抗联合多西他赛或纳武单抗单药治疗。从2019年7月至2022年6月，总共招募了22名患者，与纳武单抗组（2.0个月）相比，纳武单抗联合多西他赛组的中位无进展生存期（4.0个月）显着更长，P = 0.0019。由于招募缓慢，该研究于 2022 年 6 月结束。纳武单抗组的客观缓解率为 10.0% [95% 置信区间 (CI)，0-28.6]，纳武单抗 + 多西他赛组的客观缓解率为 25%（95% CI，0.5-49.5）（P = 0.346）。纳武单抗联合多西他赛组的疾病控制率显着更高（40.0% 对比 83.3%，P = 0.035）。纳武单抗 + 多西他赛组的总生存期 (OS) 也有所改善，但这并不具有统计学意义（10.0 个月与 7.2 个月，P = 0.129）。在纳武单抗中添加多西紫杉醇的耐受性良好，但联合治疗组的不良事件更为常见。尽管样本量较小，但结果表明，对于接受铂类化疗进展的 NSCLC 患者，在纳武单抗中添加多西紫杉醇可能是一种有前途的治疗选择，并且观察到 OS 有改善的趋势。