A pivotal bridging study of lurbinectedin as second-line therapy in Chinese patients with small cell lung cancer.

ABSTRACT: This single-arm, multi-center clinical trial aimed to evaluate the safety, tolerability, DLT, recommended dose (RD), preliminary efficacy, and pharmacokinetics (PK) characteristics of lurbinectedin, a selective inhibitor of oncogenic transcription, in Chinese patients with advanced solid tumors, including relapsed SCLC. Patients with advanced solid tumors were recruited in the dose-escalation stage and received lurbinectedin in a 3 + 3 design (two cohorts: 2.5 mg/m² and 3.2 mg/m², IV, q3wk). The RD was expanded in the following dose-expansion stage, including relapsed SCLC patients after first-line platinum-based chemotherapy. The primary endpoints included safety profile, tolerability, DLT, RD, and preliminary efficacy profile, while the secondary endpoints included

SUBMITTER: Cheng Y 

PROVIDER: S-EPMC10864288 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature