Phase III Study of Lurbinectedin Combined With Osimertinib for Treating Transformed Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new drug combination, lurbinectedin with osimertinib, in treating a rare form of cancer called transformed small cell lung cancer SCLC. This open-label Phase III trial aims to find the highest safe dose of these drugs using a dose-finding design and then expand the study to further assess the treatment. Participants will receive lurbinectedin every 21 days and osimertinib daily at assigned doses until their disease progresses or side effects become unacceptable. The trial starts with a dose de-escalation phase to identify the maximum tolerated dose based on toxicities over a 21-day period, followed by a phase II expansion including additional participants at that dose level. During the study, participants will be closely monitored for side effects and disease progression through regular testing and assessments. Researchers will measure dose-limiting toxicities within 30 days after the last dose and track progression-free survival. The trial involves ongoing treatment cycles, with careful evaluation to ensure participant safety and treatment adherence throughout the study period, which extends until 2029.

Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer