AbstractThere is still room for improvement in first-line treatment of advanced small cell lung cancer (SCLC). This trial firstly investigated efficacy and safety of antiangiogenic therapy (surufatinib) (200 mg, qd, po) plus anti-PD-1 treatment (toripalimab) (240 mg, d1, ivdrip) combined with etoposide (100 mg/m², d1-d3, iv, drip) and cisplatin (25 mg/m², d1-d3, ivdrip) for advanced SCLC as first-line treatment, which has been registered on ClinicalTrials.gov under the identifier NCT04996771.

摘要晚期小细胞肺癌（SCLC）的一线治疗仍有改进的空间。该试验首先研究了抗血管生成治疗（苏鲁法替尼）（200 mg，qd，po）加抗PD-1治疗（托利帕利单抗）（240 mg，d1，ivdrip）联合依托泊苷（100 mg/m²，d1-d3，iv，drip）和顺铂（25 mg/m²，d1-d3，ivdrip）作为一线治疗晚期小细胞肺癌的疗效和安全性，该药物已在ClinicalTrials.gov上注册，标识符为NCT04996771。

The four-drug regimen was conducted q3w for 4 cycles with maintenance therapy of surufatinib and toripalimab. The primary endpoint was progression-free survival (PFS). The secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety. All of the 38 patients were enrolled for safety analysis, while only 35 patients were enrolled for efficacy analysis since loss of efficacy evaluation in 3 cases after treatment.

四药方案在q3w进行4个周期，并维持苏鲁法替尼和托利帕利单抗的治疗。主要终点是无进展生存期（PFS）。次要终点包括客观缓解率（ORR），疾病控制率（DCR），总生存率（OS）和安全性。。

After a median follow-up of 21.3 months, the ORR was 97.1% (34/35), and the DCR and the tumor shrinkage rate were both 100% (35/35). The median PFS was 6.9 months (95% CI: 4.6 m–9.2 m) and the median OS was 21.1 months (95% CI: 12.1 m–30.1 m). The 12-month, 18-month, and 24-month OS rates were 66.94%, 51.39% and 38.54%.

中位随访21.3个月后，ORR为97.1%（34/35），DCR和肿瘤缩小率均为100%（35/35）。中位PFS为6.9个月（95%CI:4.6m-9.2m），中位OS为21.1个月（95%CI:12.1m-30.1m）。12个月，18个月和24个月的OS率分别为66.94%，51.39%和38.54%。

The occurrence rate of grade ≥3 treatment-emergent adverse events (TEAEs) was 63.2% (24/38), including neutrophil count decreased (31.6%, 12/38), white blood cell count decreased (23.7%, 9/38) and platelet count decreased (10.5%, 4/38). No unexpected adverse events occurred. This novel four-drug regimen (surufatinib, toripalimab, etoposide plus cisplatin) revealed impressive therapeutic efficacy and tolerable toxicities..

≥3级治疗紧急不良事件（TEAE）发生率为63.2%（24/38），其中中性粒细胞计数下降（31.6%，12/38），白细胞计数下降（23.7%，9/38），血小板计数下降（10.5%，4/38）。没有发生意外的不良事件。这种新型的四药方案（苏鲁法替尼，托利帕利单抗，依托泊苷加顺铂）显示出令人印象深刻的治疗效果和可耐受的毒性。。

IntroductionThe main cause of morbidity and mortality in malignant tumor is lung cancer.1 There are approximately 2.2 million incidental lung cancer cases globally in 2020, with about 13–15% small cell lung cancer (SCLC) accounts for the contribution.2Tobacco smoking is the leading risk factor for SCLC which accounts for ≥ 95% of the whole population in SCLC patients.3 SCLC is a kind of neuroendocrine tumor (NET) clinically characterized by a rapid growth and early distant metastasis.3 It is usually diagnosed at the extensive stage (ES) with prognosis poor.3 As a highly aggressive subtype of lung NET, SCLC is characterized by deletion of multiple tumor suppressor genes, such as mutations in TP53 and RB1.4 This characteristic also determines that SCLC is difficult to be treated with target therapy precisely.

引言恶性肿瘤发病率和死亡率的主要原因是肺癌。1 2020年，全球约有220万例偶然发生的肺癌病例，其中约13-15%的小细胞肺癌（SCLC）占了这一比例。2吸烟是SCLC的主要危险因素，占SCLC患者总人口的95%以上。3 SCLC是一种神经内分泌肿瘤（NET），临床表现为快速生长和早期远处转移。3它通常被诊断为广泛期，预后较差。3作为肺NET的高度侵袭性亚型，SCLC的特征是多个抑癌基因的缺失，如TP53突变RB1.4这一特征也决定了SCLC很难用靶向治疗精确治疗。

Traditional chemotherapy has always been unable to bring significant survival benefits to ES-SCLC patients.5 In the past 30 years, etoposide combined with cisplatin/carboplatin has been the most commonly used therapeutic regimen for treatment-naïve ES-SCLC. The objective response rate (ORR) of this platinum–etoposide doublet regimen ranges from 44% to 78%, with about 4–5 months as the median progression-free survival (mPFS) and 10 months as the median overall survival (mOS).6With the development of immunotherapy, ES-SCLC has ushered in a breakthrough in first-line treatment.7 Multiple phase III randomized controlled clinical studies have proved that the efficacy of anti-programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) inhibitors, such as atezolizumab, durvalumab, serplulimab, adebrelimab, tislelizumab or toripalimab, combined with etoposide plus cisplatin/carboplatin is significantly better than platinum–etoposide doublet regimen.

传统的化疗一直无法为ES-SCLC患者带来显着的生存益处。在过去的30年中，依托泊苷联合顺铂/卡铂一直是治疗初治ES-SCLC最常用的治疗方案。这种铂-依托泊苷双联方案的客观缓解率（ORR）在44%至78%之间，中位无进展生存期（mPFS）约为4-5个月，中位总生存期（mOS）约为10个月。6随着免疫疗法的发展，ES-SCLC在一线治疗方面取得了突破。7多个III期随机对照临床研究证明，抗程序性死亡-1（PD-1）/程序性死亡配体-1（PD-L1）抑制剂（如atezolizumab，durvalumab，serplulimab，adebrelimab，tislelizumab或toripalimab）联合依托普利单抗的疗效Poside加顺铂/卡铂明显优于铂-依托泊苷双重方案。

The mPFS is still about 4.

mPFS仍然约为4。

Data availability

数据可用性

The original data supporting the results of this manuscript had been deposited in the Research Data Deposit repository (https://www.researchdata.org.cn) under the accession code (RDDA2024883468). Access to the data should be requested by the corresponding authors. Besides, processed NGS data of 8 enrolled patients was consolidated in Data S1..

支持该手稿结果的原始数据已保存在研究数据库中(https://www.researchdata.org.cn)根据加入代码（RDDA2024883468）。通讯作者应要求访问数据。此外，8名登记患者的NGS数据已整合到数据S1中。。

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Download referencesAcknowledgementsThe authors thank the study participants, investigators, and study site staff for their contribution to the study. The authors would also like to thank Xiaochong Tang, Xing Lv, and Jiancai Zhou for their contributions to the manuscript. The study was funded by the Chinese National Natural Science Foundation Project (Grant No.

下载参考文献致谢作者感谢研究参与者，研究人员和研究现场工作人员对研究的贡献。作者还要感谢唐晓冲，邢律和周建才对稿件的贡献。该研究由中国国家自然科学基金项目（批准号：。

82173101, 82373262, 82241232, 82272789, 82102872, 82102864) and Guangzhou Basic and Applied Basic Research Foundation (2024A04J4082).Author informationAuthor notesThese authors contributed equally: Yaxiong Zhang, Yan Huang, Yunpeng Yang, Yuanyuan Zhao, Ting ZhouAuthors and AffiliationsDepartment of Medical Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, ChinaYaxiong Zhang, Yan Huang, Yunpeng Yang, Yuanyuan Zhao, Ting Zhou, Gang Chen, Shen Zhao, Huaqiang Zhou, Shaodong Hong, Li Zhang & Wenfeng FangDepartment of Clinical Research, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, ChinaYuxiang Ma & Hongyun ZhaoAuthorsYaxiong ZhangView author publicationsYou can also search for this author in.

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PubMed Google ScholarContributionsYaxiong Zhang, Yan Huang, Yunpeng Yang, Yuanyuan Zhao, and Ting Zhou equally contributed to the acquisition, analysis, and interpretation of the data and drafting of the manuscript. Gang Chen and Shen Zhao made the follow-up. Huaqiang Zhou completed the statistical analysis.

PubMed谷歌学术贡献张亚雄，黄燕，杨云鹏，赵元元和周婷同样为数据的获取，分析和解释以及手稿的起草做出了贡献。陈刚和申昭进行了跟进。周华强完成了统计分析。

Yuxiang Ma, Shaodong Hong, and Hongyun Zhao performed critical revisions of the manuscript. Li Zhang and Wenfeng Fang significantly contributed to the conception and design of this study. All authors have read and approved the article.Corresponding authorsCorrespondence to.

马玉祥，洪少东和赵红云对稿件进行了严格的修订。Li Zhang和Wenfeng Fang为本研究的概念和设计做出了重大贡献。所有作者都阅读并批准了这篇文章。通讯作者通讯。

Li Zhang or Wenfeng Fang.Ethics declarations

李章或方文峰。道德宣言

Competing interests

相互竞争的利益

The authors declare no competing interests.

作者声明没有利益冲突。

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Reprints and permissionsAbout this articleCite this articleZhang, Y., Huang, Y., Yang, Y. et al. Surufatinib plus toripalimab combined with etoposide and cisplatin as first-line treatment in advanced small-cell lung cancer patients: a phase Ib/II trial.

转载和许可本文引用本文Zhang，Y.，Huang，Y.，Yang，Y。et al。Surufatinib加toripalimab联合依托泊苷和顺铂作为晚期小细胞肺癌患者的一线治疗：Ib/II期试验。

Sig Transduct Target Ther 9, 255 (2024). https://doi.org/10.1038/s41392-024-01974-2Download citationReceived: 04 April 2024Revised: 01 September 2024Accepted: 13 September 2024Published: 27 September 2024DOI: https://doi.org/10.1038/s41392-024-01974-2Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard.

Sig Transduct Target Ther 9255（2024）。https://doi.org/10.1038/s41392-024-01974-2Download引文收到日期：2024年4月4日修订日期：2024年9月1日接受日期：2024年9月13日发布日期：2024年9月27日OI：https://doi.org/10.1038/s41392-024-01974-2Share本文与您共享以下链接的任何人都可以阅读此内容：获取可共享链接对不起，本文目前没有可共享的链接。复制到剪贴板。

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