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Patients with advanced solid tumors were recruited in the dose-escalation stage and received lurbinectedin in a 3\u2009+\u20093 design (two cohorts: 2.5\u00a0mg\/m<jats:sup>2<\/jats:sup> and 3.2\u00a0mg\/m<jats:sup>2<\/jats:sup>, IV, q3wk). The RD was expanded in the following dose-expansion stage, including relapsed SCLC patients after first-line platinum-based chemotherapy. The primary endpoints included safety profile, tolerability, DLT, RD, and preliminary efficacy profile, while the secondary endpoints included PK characteristics. In the dose-escalation stage, ten patients were included, while one patient had DLT in the 3.2\u00a0mg\/m<jats:sup>2<\/jats:sup> cohort, which was also the RD for the dose-expansion stage. At cutoff (May 31, 2022), 22 SCLC patients were treated in the ongoing dose-expansion stage, and the median follow-up was 8.1\u00a0months (range 3.0\u201311.7). The most common grade\u2009\u2265\u20093 treatment-related adverse events (TRAEs) included neutropenia (77.3%), leukopenia (63.6%), thrombocytopenia (40.9%), anemia (18.2%), and ALT increased (18.2%). The most common severe adverse events (SAEs) included neutropenia (27.3%), leukopenia (22.7%), thrombocytopenia (18.2%), and vomiting (9.1%). No treatment-related deaths occurred. The Independent Review Committee (IRC)-assessed ORR was 45.5% (95% CI 26.9\u201365.3). Lurbinectedin at the RD (3.2\u00a0mg\/m<jats:sup>2<\/jats:sup>) showed manageable safety and acceptable tolerability in Chinese patients with advanced solid tumors, and demonstrates promising efficacy in Chinese patients with SCLC as second-line therapy.<\/jats:p><jats:p><jats:bold>Trial registration:<\/jats:bold> This study was registered with ClinicalTrials.gov NCT04638491, 20\/11\/2020.<\/jats:p>","DOI":"10.1038\/s41598-024-54223-5","type":"journal-article","created":{"date-parts":[[2024,2,13]],"date-time":"2024-02-13T08:02:05Z","timestamp":1707811325000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["A pivotal bridging study of lurbinectedin as second-line therapy in Chinese patients with small cell lung cancer"],"prefix":"10.1038","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct04638491","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Ying","family":"Cheng","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunjiao","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lin","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanqiu","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lulu","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Xin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liang","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pinhua","family":"Pan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xingya","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaorong","family":"Dong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ke","family":"Tang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emei","family":"Gao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fei","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,2,13]]},"reference":[{"key":"54223_CR1","doi-asserted-by":"publisher","first-page":"2244","DOI":"10.1158\/1078-0432.CCR-14-2958","volume":"21","author":"MC Pietanza","year":"2015","unstructured":"Pietanza, M. C., Byers, L. A., Minna, J. D. & Rudin, C. M. Small cell lung cancer: Will recent progress lead to improved outcomes? Clin. Cancer Res. 21, 2244\u20132255 (2015).","journal-title":"Clin. Cancer Res."},{"key":"54223_CR2","doi-asserted-by":"publisher","first-page":"765","DOI":"10.1038\/nrc.2017.106","volume":"17","author":"AF Gazdar","year":"2017","unstructured":"Gazdar, A. F., Bunn, P. A. & Minna, J. D. Small-cell lung cancer: What we know, what we need to know and the path forward. Nat. Rev. Cancer 17, 765 (2017).","journal-title":"Nat. Rev. Cancer."},{"key":"54223_CR3","doi-asserted-by":"publisher","first-page":"1599","DOI":"10.1016\/j.mayocp.2019.01.034","volume":"94","author":"S Wang","year":"2019","unstructured":"Wang, S., Zimmermann, S., Parikh, K., Mansfield, A. S. & Adjei, A. A. Current diagnosis and management of small-cell lung cancer. Mayo Clin. Proc. 94, 1599\u20131622 (2019).","journal-title":"Mayo Clin. 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All other authors declare no competing interests.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"3598"}}