Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
brief summary
This open-label, Phase I/II trial is studying the safety and effectiveness of an experimental drug combination, lurbinectedin with osimertinib, against a rare type of cancer known as transformed small cell lung cancer (SCLC).
detailed description
This is an open label prospective multicenter Phase Ib/II trial utilizing a Bayesian Optimal Interval (BOIN) dose-finding design to identify the maximum tolerated dose (MTD) based on DLTs of lurbinectedin and osimertinib. DLT period is 21 days beginning on C1D1. Once the MTD has been identified, 10 subjects total will be enrolled in a Phase II expansion. This number includes the 3 initial subjects in the corresponding MTD group. Subjects will receive a combination of lurbinectedin every 21 days and osimertinib daily, until progression or unacceptable toxicities.
official title
Phase I/II Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer