Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer.

Summary

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.

Timeline

Start

2020-09-21

Primary completion

2023-09-30

Completion

2025-05-20

Publications

• Calles A, Navarro A, Doger de Speville Uribe BG, Colome EA, de Miguel M, Alvarez R, Arregui M, Moreno V, Rocha P, Calvo E, Ramon-Patino J, Corral de la Fuente E, Alcala-Lopez D, Boix O, Fernandez-Pinto M, Rodriguez-Morato J, Palmero R, Nadal E, Jove M, Felip E. Lurbinectedin Plus Pembrolizumab in Relapsed SCLC: The Phase I/II LUPER Study. J Thorac Oncol. 2025 Jul;20(7):969-982. doi: 10.1016/j.jtho.2025.02.005. Epub 2025 Feb 10.

Drugs

Indications