NCT06497530

Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC

An Exploratory Study of Maintenance Lurbinectedin in Combination With Serplulimab for Patients With Extensive-Stage Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Guangzhou Institute of Respiratory Disease · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-lable exploratory study of Lurbinectedin in combination with Serplulimab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and Serplulimab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and Serplulimab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will receive lurbinectedin plus Serplulimab in the maintenance phase.

Conditions

• Extensive-Stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Serplulimab	Serplulimab will be administered intravenously at a dose of 4.5 mg/kg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Serplulimab will be administered intravenously at a dose of 4.5 mg/kg on Day 1 of each 21-day cycle in the maintenance phase.
DRUG	Lurbinectedin	Lurbinectedin will be administered intravenously at a fixed dose of 4 mg on Day 1 of each 21-day cycle in the maintenance phase.
DRUG	Carboplatin	Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
DRUG	Etoposide	Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2024-07-11
• Last updated: 2024-07-12