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

Sponsor
Guangzhou Institute of Respiratory Disease
Study ID
NCT06497530
Phase
PHASE2
Status
Recruiting
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Conditions

  • Extensive-Stage Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    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 — DRUG
    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 — DRUG
    Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
  • Etoposide — DRUG
    Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.

Study Details

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.

Key Dates

Start date
Dec 1, 2024
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Treatment
    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 Measure

Progression-Free Survival (PFS) [ Time Frame: Initiation of maintenance therapy to the date of first documented disease progression or death whichever occurs first (up to approximately 24 months) ]

Central Contacts

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