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

NCT06554535 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-08-15

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Serplulimab，Platinum-based Chemotherapy，Aspirin

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.

Sponsors & Collaborators

  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-10-01
Completion
2027-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06554535 on ClinicalTrials.gov