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To evaluate the real-world effectiveness and safety of first-line serplulimab plus chemotherapy in China and to benchmark outcomes against the pivotal trial using a matching-adjusted indirect comparison (MAIC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This nationwide, observational study enrolled ES-SCLC patients treated with serplulimab and investigator-selected chemotherapy across 14 sites in China. For subsequent analyses, patients were grouped by alignment with the ASTRUM-005 trial regimen: an RCT-regimen cohort and a real-world regimen cohort. The primary endpoints were overall survival (OS) and real-world progression-free survival (rwPFS); secondary endpoints included objective response rate (ORR) and safety. The MAIC weighted eligible real-world patients to the aggregate baseline profile of the pivotal trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 635 patients, the median OS was 17.20 months (95% CI, 15.43\u201319.77) and the median rwPFS was 8.17 months (95% CI, 7.40\u20139.20). The ORR was 69.05%, with comparable efficacy observed between RCT-regimen and real-world cohorts. Poor performance status and liver metastases independently predicted higher mortality. In the MAIC, OS in the RCT-regimen cohort was comparable to the serplulimab arm of the pivotal ASTRUM-005 trial (weighted log-rank\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.784). Safety was manageable and consistent with known profiles.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This large-scale real-world study confirms the efficacy of serplulimab plus chemotherapy and tolerability in diverse ES-SCLC population, supporting the external validity and generalizability of the pivotal ASTRUM-005 trial results.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov (NCT06748495).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12916-026-05055-9","type":"journal-article","created":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T03:29:25Z","timestamp":1784086165000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-world serplulimab plus chemotherapy for extensive-stage small cell lung cancer in china: an external validation of ASTRUM-005 trial"],"prefix":"10.1186","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7078-7767","authenticated-orcid":false,"given":"Lin","family":"Wu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chengping","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenzhong","family":"Su","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Hong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haichuan","family":"Su","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tao","family":"Luo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhigang","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhentian","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qing","family":"Pu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caixia","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuhong","family":"Min","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Guo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yifei","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,7,15]]},"reference":[{"key":"5055_CR1","doi-asserted-by":"publisher","first-page":"1906","DOI":"10.1001\/jama.2025.0560","volume":"333","author":"SY Kim","year":"2025","unstructured":"Kim SY, Park HS, Chiang AC. 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The study protocol was approved by the Institutional Ethics Review Board of Hunan Cancer Hospital (approval number: 2024KS10), and all participating centers provided institutional approval. Written informed consent was obtained from all enrolled patients.","order":1,"name":"Ethics","label":"Ethics approval and consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":2,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":3,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"558"}}