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Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer.
This is a prospective, open-label, uncontrolled and multicenter phase I/II study of PM01183 in combination with pembrolizumab in patients with relapsed small cell lung cancer (SCLC). The study will be divided into two stages: * A dose-ranging phase I stage with escalating doses of PM01183 in combination with a fixed dose of pembrolizumab, followed by: * A non-randomized phase II stage as an expansion study at the recommended dose (RD) determined during the phase I stage. The phase I stage will focus on the selection of the RD based on safety/tolerability, while the phase II stage will assess the overall response rate (ORR) and clinical response.
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