RecruitingPhase 2NCT06497530

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

Sponsor

Guangzhou Institute of Respiratory Disease

Enrollment

30 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Extensive-stage Small-cell Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Carboplatin, a drug called Etoposide, and others for people with extensive-stage small-cell lung cancer. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSerplulimab

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.

DRUGLurbinectedin

Lurbinectedin will be administered intravenously at a fixed dose of 4 mg on Day 1 of each 21-day cycle in the maintenance phase.

DRUGCarboplatin

Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.

DRUGEtoposide

Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.

Locations(1)

The first affiliated hospital of Guangzhou medical university

Guangzhou, Guangdong, China

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NCT06497530

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