Efficacy and Safety of Serplulimab With Chemotherapy and Aspirin in Untreated Extensive-Stage Small Cell Lung Cancer

Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study ID
NCT06554535
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • ECOG Performance Status Score of 0 or 1
  • Expected Survival ≥3 Months
  • Extensive-Stage Small Cell Lung Cancer
  • Treatment-naïve for Systemic Therapy Targeting Extensive-Stage Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Serplulimab，Platinum-based Chemotherapy，Aspirin — DRUG
    Participants will receive an induction therapy consisting of Serplulimab (4.5 mg/kg IV on Day 1), Carboplatin (AUC 5 IV on Day 1) or Cisplatin (75 mg/m² IV on Day 1), Etoposide (100 mg/m² IV on Days 1-3), and Bayer Aspirin (100 mg PO daily). This induction phase will be administered every 3 weeks for 4 cycles. Following the induction phase, participants will transition to a maintenance therapy phase where they will continue to receive Serplulimab (4.5 mg/kg IV on Day 1, every 3 weeks) and Bayer Aspirin (100 mg PO daily) until disease progression or intolerable toxicity.

Study Details

Lung cancer remains a leading cause of cancer-related deaths worldwide, with small cell lung cancer (SCLC) accounting for 15-20% of all lung cancers. Extensive-stage SCLC (ES-SCLC) is associated with poor prognosis, with a median survival of 2-4 months without treatment. Although platinum-based chemotherapy is the standard first-line treatment, median survival remains under one year, highlighting the need for improved outcomes. Recent studies have demonstrated that combining PD-1 inhibitors with chemotherapy can significantly improve survival in ES-SCLC patients. Serplulimab, a novel PD-1 inhibitor, has shown promising results in extending overall survival when combined with chemotherapy in a Phase III trial. Additionally, aspirin has been found to enhance the anti-tumor effects of immunotherapy by inhibiting immune checkpoint proteins and reducing adverse events such as thrombosis and fever. This Phase II study aims to evaluate the efficacy and safety of combining serplulimab, platinum-based chemotherapy, and aspirin as a first-line treatment for patients with ES-SCLC.

Key Dates

Start date
Oct 1, 2024
Status verified
Aug 2024
Primary completion
Oct 1, 2026
Completion
Oct 1, 2027

Study Design

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

Arms

  • Experimental: Serplulimab + Chemotherapy + Aspirin

Primary Outcome Measure

Progression-Free Survival [ Time Frame: Up to 2 years ]

Central Contacts

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