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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Lurbinectedin will be administered intravenously at a fixed dose of 4 mg on Day 1 of each 21-day cycle in the maintenance phase.
Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.
The first affiliated hospital of Guangzhou medical university
Guangzhou, Guangdong, China
RECRUITINGProgression-Free Survival (PFS)
progression-free survival (PFS) is defined as the time from the initiation of maintenance therapy to the date of first documented disease progression (as assessed according to RECIST v1.1) or death whichever occurs first.
Time frame: Initiation of maintenance therapy to the date of first documented disease progression or death whichever occurs first (up to approximately 24 months)
Overall Survival (OS)
Overall survival (OS) is defined as the time from the initiation of maintenance therapy to the date of death from any cause.
Time frame: Initiation of maintenance therapy to the date of death from any cause (up to approximately 24 months)
Objective Response Rate (ORR)
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.
Time frame: up to approximately 24 months
Duration of Response (DOR)
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.
Time frame: up to approximately 24 months
Percentage of Participants With Adverse Events
Percentage of participants with adverse events
Time frame: up to approximately 24 months
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