目的 探讨信迪利单抗联合盐酸安罗替尼二线治疗驱动基因阴性晚期或转移性非鳞非小细胞肺癌的临床效果和安全性。方法 选择2018年1月至2018年12月在我院进行化疗的驱动基因阴性晚期或转移性非鳞非小细胞肺癌患者45例，按1∶1∶1随机分配为3个治疗组，其中A组患者接受信迪利单抗联合盐酸安罗替尼治疗，B组接受信迪利单抗单药治疗，C组接受多西他赛单药治疗，比较3组患者的疗效、药物相关不良反应和生存情况。结果 3组总缓解率（χ^2=7.222）、疾病控制率（χ^2=6.738）比较，P＜0.05，差异具有统计学意义“,”Objective To investigate the clinical efficacy and safety of cindilimab combined with anlotinib hydrochloride as second-line therapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC). Methods Forty-five patients with advanced or NSCLC with negative driving gene who received chemotherapy in our hospital from January 2018 to December 2018 were randomly divided into three treatment groups according to the ratio of 1∶1∶1. The patients received the treatment of sindilimab combined with anlotinib hydrochloride as the group A， received the monotherapy of sindilimab as the group B， and received the monotherapy of docetaxel as the group C. Compare the efficacy， drug-related adverse reactions and survival among the three groups. Results The difference of the total remission rate (χ^2=7.222) and disease control rate (χ^2=6.738) for groups was statistically significant (P＜0.05).The incidence of adverse reactions in the three groups (χ^2=3.379)， the difference was not statistically signifiant;the adverse reactions of the three groups of patients were compared with grades less than 3 and ≥3 (χ^2=9.729)， P＜0.05， the difference was statistically significant. The median survival time of group A was 18 months， that of group B was 11 months， and that of group C was 9 months. The difference of the survival time (χ^2=26.080， P=0.000) of all groups was statistically significant (P＜0.05) by Kaplan-Meier survival analysis. The difference of the PFS and OS for all groups was statistically significant （P＜0.05).The cumulative survival rate of the group A was higher than the group B and the group C according to the survival curve. Conclusion The sindilimab combined with anlotinib hydrochloride as second-line therapy for EGFR/ALK/ros1 negative advanced or metastatic NSCLC is effective， safe and tolerable.