BACKGROUND CheckMate 171 (NCT02409368) is an open-label, multicentre, phase 2 trial of nivolumab in previously treated advanced squamous non-small cell lung cancer (NSCLC), conducted as part of a post-approval commitment to the European Medicines Agency (EMA). We report outcomes from this trial. METHODS Patients with Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2 and disease progression during/after ≥1 systemic treatment (≥1 being platinum-based chemotherapy) for advanced or metastatic disease were treated with nivolumab 3 mg/kg every 2 weeks until progression or unacceptable toxicity. The primary end-point was incidence of grade 3-4 treatment-related select adverse events (AEs). Other end-points included overall survival (OS) and safety. RESULTS Of 811 patients treated, 103 had ECOG PS 2; 278 were aged ≥70 years and 125 were ≥75 years of age. Minimum follow-up was ~18 months. Safety was similar across populations; the most frequent grade 3-4 treatment-related select AEs in all treated patients were diarrhoea (1%), increased alanine aminotransferase (ALT, 1%), pneumonitis (0.7%), colitis (0.6%) and increased aspartate aminotransferase (AST, 0.5%). Median OS was similar in all treated patients and those aged ≥70 and ≥75: 10.0 months, 10.0 months and 11.2 months, respectively. Median OS was 5.2 months in patients with ECOG PS 2. CONCLUSION These results suggest that nivolumab is well tolerated and active in patients with advanced, relapsed squamous NSCLC, including the elderly, with OS outcomes consistent with phase 3 data. In patients with ECOG PS 2, nivolumab had similar tolerability, but outcomes were worse, as expected in this difficult-to-treat, poor prognosis population. CLINICAL TRIAL REGISTRATION NCT02409368.

中文翻译：

---

CheckMate 171：Nivolumab的2期试验，用于先前接受过治疗的晚期鳞状非小细胞肺癌患者，包括ECOG PS 2和老年人群。

背景CheckMate 171（NCT02409368）是nivolumab在先前治疗的晚期鳞状非小细胞肺癌（NSCLC）中进行的一项开放性，多中心，2期临床试验，是对欧洲药品管理局（EMA）的批准后承诺的一部分）。我们报告了该试验的结果。方法东部合作肿瘤小组表现状态（ECOG PS）为0-2且≥1全身治疗（≥1为铂类化学疗法）的晚期或转移性疾病期间或之后的疾病进展，每2个月用nivolumab 3 mg / kg进行治疗数周直至进展或出现不可接受的毒性。主要终点是3-4级与治疗相关的选择不良事件（AE）的发生率。其他终点包括总体生存期（OS）和安全性。结果在811例患者中，有103例患有ECOG PS 2。278岁≥70岁，125岁≥75岁。最小随访时间约为18个月。人群之间的安全性相似。在所有接受治疗的患者中，最常见的3-4级与治疗相关的选择AE是腹泻（1％），丙氨酸转氨酶（ALT，1％），肺炎（0.7％），结肠炎（0.6％）和天冬氨酸转氨酶（AST）增加，0.5％）。在所有接受治疗的患者和≥70岁和≥75岁的患者中，OS中位数相似：分别为10.0个月，10.0个月和11.2个月。ECOG PS 2患者的中位OS为5.2个月。结论这些结果表明，对于晚期，复发性鳞状NS​​CLC患者（包括老年人），nivolumab具有良好的耐受性和活动性，其OS结局与3期数据一致。在ECOG PS 2患者中，nivolumab具有相似的耐受性，但结果较差，如预期的那样，在这个难以治疗的不良预后人群中。临床试验注册NCT02409368。