{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T00:31:59Z","timestamp":1747182719160,"version":"3.40.5"},"reference-count":21,"publisher":"Wiley","issue":"28","license":[{"start":{"date-parts":[[2023,9,7]],"date-time":"2023-09-07T00:00:00Z","timestamp":1694044800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Thoracic Cancer"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Combined treatment using anti\u2010programmed death\u2010ligand 1 antibody (anti\u2010PD\u2010L1) and platinum\u2010etoposide is the current standard first\u2010line treatment for patients with extensive\u2010stage (ES) small cell lung cancer (SCLC). However, the best treatment for relapsed ES\u2010SCLC after the first\u2010line treatment remains unclear. There are some approved chemotherapeutic agents that can be used against ES\u2010SCLC, and treatment with irinotecan is well established as both a monotherapy and a combined therapy, in combination with platinum. Therefore, we conduct a phase II study with irinotecan in the second\u2010 or later\u2010line setting for patients with ES\u2010SCLC who have been previously treated with combined treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Our study will enroll total 30 patients who are diagnosed with ES\u2010SCLC and have experienced disease progression after the combined treatment. Patients will receive irinotecan on days 1, 8, and 15, which will be repeated every 4\u2009weeks. Doses of irinotecan (100\/80\/60\u2009mg\/m<jats:sup>2<\/jats:sup>) will be determined according to the type of UGT1A1 gene polymorphism, and the treatment will be discontinued following disease progression, intolerance, withdrawal of patient consent, and based on the investigator's decision. The primary endpoint of the study is the response rate, and the secondary endpoints are overall survival, progression\u2010free survival, and safety.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>Since the present first\u2010line treatment has been changed to the combined treatment, the second\u2010 or later\u2010line treatment should be re\u2010evaluated for patients with relapsed SCLC. Irinotecan is a major chemotherapeutic agent used for SCLC. This study demonstrates and re\u2010evaluates the clinical benefits of irinotecan after combined treatment with anti\u2010PD\u2010L1 and platinum\u2010etoposide for patients with ES\u2010SCLC.<\/jats:p><\/jats:sec><jats:sec><jats:title>Registration details<\/jats:title><jats:p>This study was registered in the Japan Registry of Clinical Trials (no. jRCT s071210090) on November 4, 2021.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1759-7714.15097","type":"journal-article","created":{"date-parts":[[2023,9,7]],"date-time":"2023-09-07T08:40:09Z","timestamp":1694076009000},"page":"2890-2894","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Phase <scp>II<\/scp> study of <scp>IRInotecan<\/scp> treatment after <scp>COmbined<\/scp> chemo\u2010immunotherapy for extensive\u2010stage small cell lung cancer: Protocol of <scp>IRICO<\/scp> study"],"prefix":"10.1111","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-2748-9418","authenticated-orcid":false,"given":"Hiromi","family":"Tomono","sequence":"first","affiliation":[{"name":"Department of Respiratory Medicine Nagasaki University Graduate School of Biomedical Sciences  Nagasaki Japan"},{"name":"Department of Respiratory Medicine National Hospital Organization Nagasaki Medical Center  Nagasaki Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2414-8344","authenticated-orcid":false,"given":"Hirokazu","family":"Taniguchi","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine Nagasaki University Graduate School of Biomedical Sciences  Nagasaki Japan"},{"name":"Clinical Oncology Center Nagasaki University Hospital  Nagasaki 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