Durvalumab 是一种针对程序性死亡配体-1 (PD-L1) 的检查点抑制剂，而安罗替尼是一种新型口服多靶点酪氨酸激酶抑制剂 (TKI)。两种药物均已在中国获得批准。临床前和临床试验表明，抗血管生成疗法具有缓解免疫抑制的潜力，并与 ICI 联合使用时显示出协同效应。然而，尚不清楚这种组合在 ES-SCLC 患者中作为维持治疗是否有效。这是一项多中心、随机、II 期研究。总计 64 名符合资格的患者，在四个周期的铂类化疗联合 durvalumab 后未出现疾病进展，将被随机分配至 durvalumab 联合安罗替尼或单独 durvalumab，直至疾病进展、撤回同意或出现不可接受的毒性。主要终点是 PFS（来自随机化）；次要终点是 OS 和 PFS（根据诊断）、客观缓解率 (ORR)；根据美国国家癌症研究所不良事件通用术语标准 (CTCAE) 5.0 版评估疾病控制率 (DCR) 和缓解持续时间 (DOR)、安全性和耐受性。我们进行了一项 II 期研究，以调查 durvalumab 联合用药的安全性和有效性使用安罗替尼作为 ES-SCLC 患者的维持治疗。© 2023 作者。约翰·威利出版的《临床呼吸杂志》

Durvalumab is a check-point inhibitor against programmed death ligand-1 (PD-L1), and anlotinib is a new orally administered multitarget tyrosine kinase inhibitor (TKI). Both agents have been approved in China. Preclinical and clinical trials have suggested that antiangiogenic therapy has the potential to alleviate immunosuppression and showed synergetic effect when combined with ICIs. However, it is unclear that whether this combination is effective when initiated as maintenance treatment in ES-SCLC patients.This is a multicenter, randomized, phase II study. A total of 64 eligible patients who do not experience disease progression after four cycles platinum-based chemotherapy combined with durvalumab will be randomized to durvalumab with anlotinib or durvalumab alone until disease progression, withdrawal of consent, or unacceptable toxicity. The primary endpoint is PFS (from randomization); secondary endpoint was OS and PFS (from diagnosis), objective response rate (ORR); disease control rate (DCR) and duration of response (DOR), safety and tolerability assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.We conduct a phase II study to investigate the safety and efficacy of durvalumab combined with anlotinib as maintenance treatment in ES-SCLC patients.© 2023 The Authors. The Clinical Respiratory Journal published by John Wiley & Sons Ltd.