Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06497530
- Lead Sponsor
- Guangzhou Institute of Respiratory Disease
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Treatment Carboplatin Induction phase：participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase：participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with Lurbinectedin on Day 1 of each 21-day cycle. Experimental Treatment Lurbinectedin Induction phase：participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase：participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with Lurbinectedin on Day 1 of each 21-day cycle. Experimental Treatment Serplulimab Induction phase：participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase：participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with Lurbinectedin on Day 1 of each 21-day cycle. Experimental Treatment Etoposide Induction phase：participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase：participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with Lurbinectedin on Day 1 of each 21-day cycle.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Treatment initiation to the date of first documented disease progression or death whichever occurs first (up to approximately 24 months) progression-free survival (PFS) is defined as the time from treatment initiation to the date of first documented disease progression (as assessed according to RECIST v1.1) or death whichever occurs first.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) up to approximately 24 months Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response until disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Percentage of Participants With Adverse Events up to approximately 24 months Percentage of participants with adverse events
Overall Survival (OS) Treatment initiation to the date of death from any cause(up to approximately 24 months) Overall survival (OS) is defined as the time from treatment initiation to the date of death from any cause.
Objective Response Rate (ORR) up to approximately 24 months Objective response rate (ORR) is defined as the proportion of participants with a complete response（CR） or partial response（PR） according to RECIST v1.1.