Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer.
Status:
Recruiting
Trial end date:
2023-08-31
Target enrollment:
Participant gender:
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.