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An expansion cohort further evaluated this combination. <jats:italic>Patients and methods<\/jats:italic> Twenty-eight patients with relapsed SCLC after no more than one line of cytotoxic-containing chemotherapy were treated: 18 (64%) with sensitive disease (chemotherapy-free interval [CTFI] \u226590\u00a0days) and ten (36%) with resistant disease (CTFI &lt;90\u00a0days; including six with refractory disease [CTFI \u226430\u00a0days]). <jats:italic>Results<\/jats:italic> Ten patients showed confirmed response (overall response rate [ORR]\u2009=\u200936%); median progression-free survival (PFS)\u2009=\u20093.3\u00a0months; median overall survival (OS)\u2009=\u20097.9\u00a0months. ORR was 50% in sensitive disease (median PFS\u2009=\u20095.7\u00a0months; median OS\u2009=\u200911.5\u00a0months) and 10% in resistant disease (median PFS\u2009=\u20091.3\u00a0months; median OS\u2009=\u20094.6\u00a0months). The main toxicity was transient and reversible myelosuppression. Treatment-related non-hematological events (fatigue, nausea, decreased appetite, vomiting, alopecia) were mostly mild or moderate. <jats:italic>Conclusion<\/jats:italic> Doxorubicin 40\u00a0mg\/m<jats:sup>2<\/jats:sup> and lurbinectedin 2.0\u00a0mg\/m<jats:sup>2<\/jats:sup> on Day 1 q3wk has shown noteworthy activity in relapsed SCLC and a manageable safety profile. The combination is being evaluated as second-line therapy for SCLC in an ongoing, randomized phase III trial. <jats:italic>Clinical trial registration<\/jats:italic><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">www.ClinicalTrials.gov<\/jats:ext-link> code: NCT01970540. Date of registration: 22 October, 2013.<\/jats:p>","DOI":"10.1007\/s10637-020-01025-x","type":"journal-article","created":{"date-parts":[[2021,3,11]],"date-time":"2021-03-11T09:12:30Z","timestamp":1615453950000},"page":"1275-1283","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Efficacy and safety of lurbinectedin and doxorubicin in relapsed small cell lung cancer. 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Emiliano Calvo has had a company leadership role, employment relationship or ownership interest for START Madrid, Oncoart Associated, International Cancer Consultants and HM Hospitals Group; has conducted consulting and advisory services, speaking or writing engagements, or public presentations for Astellas Pharma, Novartis, Nanobiotix, Pfizer, Janssen, GLG, Merck, Medscape, BMS, Pierre-Fabre, Gilead, Cerulean, Gehrman Consulting, Boehringen-Ingelheim, Seattle Genetics, Guidepoint, AstraZeneca, Roche\/Genetech, PsiOxus, Abbvie, Celgene, Servier and Amcure; has been study international principal investigator for AstraZeneca and member of study steering committees for Novartis and BeiGene, and his institution has received financial support from Abbvie, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Janssen Oncology, Hospira, Lilly, Merck, Merus, Millennium, Nanobiotix, Nektar. Novartis, OncoMed, Pfizer, PharmaMar, PsiOxus Therapeutics, Puma Biotechnology, Regeneron, Roche-Genentech, Sanofi, Spectrum Pharmaceuticals, ACEA Bio, Amcure, Cytomx, H3-Biomedicine, Incyte, Kura, LOXO, Macrogenics, Menarini, Principia, Tahio, Tesaro, BeiGene, Transgene, Takeda, Innovio, MSD, Seattle Genetics, Mersana, GSK, Daiichi, Astellas, ORCA, Boston Therapeutics, Dynavax, DebioPharma, Synthon and Rigontec. Jos\u00e9 Antonio L\u00f3pez-Vilari\u00f1o, Rafael N\u00fa\u00f1ez, Carmen Kahatt and Ali Zeaiter are employees and stock owners of Pharma Mar, S.A. Martin Cullell-Young is an employee of Pharma Mar, S.A. All remaining authors have declared no conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest\/competing interests"}},{"value":"The study was approved by the Research Ethics Committees of participating centers in Spain and the U.K. The study was conducted in full accordance with the principles of the World Medical Association Declaration of Helsinki, the International Conference of Harmonisation, and all applicable local guidelines and regulations on good clinical practice.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All patients provided written informed consent to participate in this study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"All patients provided written informed consent about participation in this study and the use of collated data. No individual patient data are included in this article that could be used to identify any individual.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}}]}}