{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T19:59:40Z","timestamp":1791316780393,"version":"4.3.1"},"reference-count":24,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,1,13]],"date-time":"2025-01-13T00:00:00Z","timestamp":1736726400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,1,13]],"date-time":"2025-01-13T00:00:00Z","timestamp":1736726400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Sig Transduct Target Ther"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    This is a randomized, double-blind, placebo-controlled phase 3 clinical trial (ClinicalTrials.gov, NCT04878016) conducted in 54 hospitals in China. Adults who were histologically diagnosed and never treated for extensive-stage small cell lung cancer (ES-SCLC) were enrolled. Eligible Patients were randomly assigned (1:1) to receive four cycles (21 days as one cycle) of intravenous carboplatin (area under the curve of 5\u2009mg\/mL per min, day 1 of each cycle) and etoposide (100\u2009mg\/m\u00b2 of body-surface area, on days 1\u20133 of each cycle) with either socazolimab (5\u2009mg\/kg, day 1 of each cycle) or matching placebo, following maintenance therapy with socazolimab or placebo. From July 15, 2021, to May 12, 2022, 498 eligible patients were randomly assigned to receive socazolimab (250 patients) or placebo (248 patients) combined with chemotherapy. As of October 13, 2023, patients treated with socazolimab presented significant overall survival (OS) benefit (13.90 months) compared with the placebo plus EC group (11.58 months) (hazard ratio for death, 0.799; 95% CI, 0.652\u20130.979;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.0158). The median progression free survival (PFS) was 5.55 months in the socazolimab plus EC group, prolonging disease progression or death by nearly 1.2 months (5.55 months vs 4.37 months, hazard ratio for progression or death, 0.569; 95% CI, 0.457\u20130.708;\n                    <jats:italic>p<\/jats:italic>\n                    \u2009&lt;\u20090.0001). 200 (80.3%) patients in the socazolimab plus EC group experienced \u2265 grade 3 treatment-related adverse events and 187 (75.7%) patients occurred in the placebo plus EC group. Socazolimab combined with standard EC regimen chemotherapy for first-line treatment of ES-SCLC significantly prolonged overall survival and did not increase the safety risk of treatment.\n                  <\/jats:p>","DOI":"10.1038\/s41392-024-02115-5","type":"journal-article","created":{"date-parts":[[2025,1,12]],"date-time":"2025-01-12T18:02:34Z","timestamp":1736704954000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer"],"prefix":"10.1038","volume":"10","author":[{"given":"Zhiwei","family":"Chen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianhua","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dingzhi","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7078-7767","authenticated-orcid":false,"given":"Lin","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tienan","family":"Yi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qiming","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liang","family":"Han","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liping","family":"Tan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yinyin","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhihong","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Na","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tongmei","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongmei","family":"Sun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Youhua","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiyong","family":"He","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Runxiang","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peng","family":"Cheng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xingya","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianhua","family":"Shi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guohua","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daiyuan","family":"Ma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin Xiaoyi","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiangrong","family":"Dai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Wong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yujie","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaohui","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8833-7262","authenticated-orcid":false,"given":"Shun","family":"Lu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the Socazolimab Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin Xiaoyi","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiangrong","family":"Dai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Wong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yujie","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaohui","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,1,13]]},"reference":[{"key":"2115_CR1","unstructured":"Howlader, N. et al. SEER cancer statistics review (CSR), 1975\u20132014. National Cancer Institute, accessed 15 April 2024; https:\/\/seer.cancer.gov\/csr\/1975_2018"},{"key":"2115_CR2","doi-asserted-by":"publisher","first-page":"4539","DOI":"10.1200\/JCO.2005.04.4859","volume":"24","author":"R Govindan","year":"2006","unstructured":"Govindan, R. et al. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J. Clin. Oncol. 24, 4539\u20134544 (2006).","journal-title":"J. Clin. Oncol."},{"key":"2115_CR3","doi-asserted-by":"publisher","first-page":"e400S","DOI":"10.1378\/chest.12-2363","volume":"143","author":"JR Jett","year":"2013","unstructured":"Jett, J. R., Schild, S. E., Kesler, K. A. & Kalemkerian, G. P. Treatment of small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 143, e400S\u2013e4419 (2013).","journal-title":"Chest"},{"key":"2115_CR4","unstructured":"Network NCC. NCCN clinical practice guidelines in oncology: small cell lung cancer, version.3, accessed 15 April 2024. https:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/nscl.pdf (2022)."},{"key":"2115_CR5","doi-asserted-by":"publisher","first-page":"1692","DOI":"10.1200\/JCO.2011.40.4905","volume":"14","author":"A Rossi","year":"2012","unstructured":"Rossi, A. et al. Carboplatin or cisplatin-based chemotherapy in first-line treatment of small-cell lung cancer: the COCIS meta-analysis of individual patient data. J. Clin. Oncol. 14, 1692\u20131698 (2012).","journal-title":"J. Clin. Oncol."},{"key":"2115_CR6","doi-asserted-by":"publisher","first-page":"2220","DOI":"10.1056\/NEJMoa1809064","volume":"23","author":"L Horn","year":"2018","unstructured":"Horn, L. et al. First-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer. N. Engl. J. Med. 23, 2220\u20132229 (2018).","journal-title":"N. Engl. J. Med."},{"key":"2115_CR7","doi-asserted-by":"publisher","first-page":"1929","DOI":"10.1016\/S0140-6736(19)32222-6","volume":"10212","author":"L Paz-Ares","year":"2019","unstructured":"Paz-Ares, L. et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet 10212, 1929\u20131939 (2019).","journal-title":"Lancet"},{"key":"2115_CR8","doi-asserted-by":"publisher","first-page":"1223","DOI":"10.1001\/jama.2022.16464","volume":"12","author":"Y Cheng","year":"2022","unstructured":"Cheng, Y. et al. Effect of first-line serplulimab vs placebo added to chemotherapy on survival in patients with extensive-stage small cell lung cancer: the ASTRUM-005 randomized clinical trial. JAMA 12, 1223\u20131232 (2022).","journal-title":"JAMA"},{"key":"2115_CR9","first-page":"739","volume":"6","author":"W Jie","year":"2022","unstructured":"Jie, W. et al. Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicenter, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 6, 739\u2013747 (2022).","journal-title":"Lancet Oncol."},{"key":"2115_CR10","doi-asserted-by":"crossref","unstructured":"Cheng, Y. et al. LBA93EXTENTORCH: a randomized, phase III trial of toripalimab versus placebo, in combination with chemotherapy as a first-line therapy for patients with extensive stage small cell lung cancer (ES-SCLC). Ann. Oncol. 34, S1334 (2023).","DOI":"10.1016\/j.annonc.2023.10.096"},{"key":"2115_CR11","doi-asserted-by":"publisher","first-page":"1073","DOI":"10.1016\/j.jtho.2024.03.008","volume":"7","author":"Y Cheng","year":"2024","unstructured":"Cheng, Y. et al. Tislelizumab plus platinum and etoposide versus placebo plus platinum and etoposide as first-line treatment for extensive-stage SCLC (RATIONALE-312): a multicenter, double-blind, placebo-controlled, randomized, phase 3 clinical trial. J. Thorac. Oncol. 7, 1073\u20131085 (2024).","journal-title":"J. Thorac. Oncol."},{"key":"2115_CR12","first-page":"5098","volume":"23","author":"L Wu","year":"2022","unstructured":"Wu, L. et al. Efficacy and safety of the anti-PD-L1 mAb socazolimab for recurrent or metastatic cervical cancer: a phase I dose-escalation and expansion study. Clin. Cancer Res. 23, 5098\u20135106 (2022).","journal-title":"Clin. Cancer Res."},{"key":"2115_CR13","first-page":"764","volume":"4","author":"Y Yao","year":"2023","unstructured":"Yao, Y. et al. First-in-maintenance therapy for localized high-grade osteosarcoma: an open-label phase I\/II trial of the anti-PD-L1 antibody ZKAB001. Clin. Cancer Res. 4, 764\u2013774 (2023).","journal-title":"Clin. Cancer Res."},{"key":"2115_CR14","first-page":"100478","volume":"4","author":"S Lu","year":"2023","unstructured":"Lu, S. et al. Efficacy and safety of anti-programmed death-ligand 1 monoclonal antibody socazolimab with carboplatin and etoposide for extensive-stage SCLC: results from the phase 1b clinical trial. JTO Clin. Res. Rep. 4, 100478 (2023).","journal-title":"JTO Clin. Res. Rep."},{"key":"2115_CR15","unstructured":"Chinese Society of Clinical Oncology. Guidelines of Chinese Society of Clinical Oncology for Small-Cell Lung Cancer. 2021. http:\/\/www.csco.org.cn."},{"key":"2115_CR16","doi-asserted-by":"publisher","first-page":"619","DOI":"10.1200\/JCO.20.01055","volume":"6","author":"SV Liu","year":"2021","unstructured":"Liu, S. V. et al. Updated overall survival and PD-L1 subgroup analysis of patients with extensive-stage small-cell lung cancer treated with atezolizumab, carboplatin, and etoposide (IMpower133). J. Clin. Oncol. 6, 619\u2013630 (2021).","journal-title":"J. Clin. Oncol."},{"key":"2115_CR17","doi-asserted-by":"publisher","first-page":"51","DOI":"10.1016\/S1470-2045(20)30539-8","volume":"1","author":"JW Goldman","year":"2021","unstructured":"Goldman, J. W. et al. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 1, 51\u201365 (2021).","journal-title":"Lancet Oncol."},{"key":"2115_CR18","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.cllc.2023.10.007","volume":"1","author":"N Florez","year":"2024","unstructured":"Florez, N. et al. Lung cancer in women: the past, present, and future. Clin. Lung Cancer 1, 1\u20138 (2024).","journal-title":"Clin. Lung Cancer"},{"key":"2115_CR19","doi-asserted-by":"publisher","first-page":"e001901","DOI":"10.1136\/jitc-2020-001901","volume":"3","author":"TU Marron","year":"2021","unstructured":"Marron, T. U. et al. Considerations for treatment duration in responders to immune checkpoint inhibitors. J. Immunother. Cancer 3, e001901 (2021).","journal-title":"J. Immunother. Cancer"},{"key":"2115_CR20","doi-asserted-by":"publisher","first-page":"1075","DOI":"10.1001\/jamaoncol.2023.1891","volume":"8","author":"L Sun","year":"2023","unstructured":"Sun, L. et al. Association between duration of immunotherapy and overall survival in advanced non\u2013small cell lung cancer. JAMA Oncol. 8, 1075\u20131082 (2023).","journal-title":"JAMA Oncol."},{"key":"2115_CR21","doi-asserted-by":"publisher","first-page":"1651","DOI":"10.1177\/1078155218805136","volume":"7","author":"A Morrow","year":"2019","unstructured":"Morrow, A. et al. Analysis of carboplatin dosing in patients with a glomerular filtration rate greater than 125\u2009mL\/min: To cap or not to cap? A retrospective analysis and review. J. Oncol. Pharm. Pract. 7, 1651\u20131657 (2019).","journal-title":"J. Oncol. Pharm. Pract."},{"key":"2115_CR22","doi-asserted-by":"publisher","first-page":"4806","DOI":"10.1158\/1078-0432.CCR-09-0344","volume":"15","author":"PH O\u2019Donnell","year":"2009","unstructured":"O\u2019Donnell, P. H. & Dolan, M. E. Cancer pharmacoethnicity: ethnic differences in susceptibility to the effects of chemotherapy. Clin. Cancer Res. 15, 4806\u20134814 (2009).","journal-title":"Clin. Cancer Res."},{"key":"2115_CR23","doi-asserted-by":"publisher","first-page":"S125","DOI":"10.1016\/j.jtho.2019.08.263","volume":"10","author":"J Hu","year":"2019","unstructured":"Hu, J. JCSE01.03 any difference on efficacy and toxicity between east and west? J. Thorac. Oncol. 10, S125 (2019).","journal-title":"J. Thorac. Oncol."},{"key":"2115_CR24","doi-asserted-by":"publisher","first-page":"3099","DOI":"10.1007\/s00432-019-03034-7","volume":"145","author":"A Wang","year":"2019","unstructured":"Wang, A. & Komiya, T. Brain metastasis as exclusion criteria in clinical trials involving extensive-stage small cell lung cancer. J. Cancer Res. Clin. Oncol. 145, 3099\u20133104 (2019).","journal-title":"J. Cancer Res. Clin. Oncol."}],"container-title":["Signal Transduction and Targeted Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41392-024-02115-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41392-024-02115-5","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41392-024-02115-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,12]],"date-time":"2025-01-12T18:02:37Z","timestamp":1736704957000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41392-024-02115-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1,13]]},"references-count":24,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,12]]}},"alternative-id":["2115"],"URL":"https:\/\/doi.org\/10.1038\/s41392-024-02115-5","relation":{},"ISSN":["2059-3635"],"issn-type":[{"value":"2059-3635","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1,13]]},"assertion":[{"value":"28 August 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 December 2024","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 December 2024","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 January 2025","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"B.X.L., X.D., M.W., Yuj.L., and X.Y. are employees of Zhaoke (Guangzhou) Oncology Pharmaceuticals. All other authors declare no competing interests.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"28"}}