NCT06554535Not yet recruitingPhase 2
Efficacy and Safety of Serplulimab With Chemotherapy and Aspirin in Untreated Extensive-Stage Small Cell Lung Cancer
A Single-center, Single-arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Platinum-based Chemotherapy and Bayer Aspirin in Previously Untreated Patients With Extensive-stage Small Cell Lung Cancer.
Source: ClinicalTrials.gov · Last updated 15 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- First submitted
- 10 Aug 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Diseases
- Lung cancer
- NCT number
- NCT06554535
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 43
- From 1 Oct 2024 to the primary completion date, 1 Oct 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving other anticoagulant therapy.
- Previous systemic anti-tumor therapy.
- Contraindications to the use of Serplulimab, Aspirin, or chemotherapy.
Other
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
Who the study is looking for
- Males or females aged ≥ 18 years.
- Histologically or cytologically confirmed ES-SCLC (according to the Veterans Administration Lung Cancer Group \[VALG\] staging system).
- Treatment-naïve for systemic therapy targeting ES-SCLC.
- Patients must have at least one tumor lesion that meets the following criteria: previously untreated, accurately measurable, with a longest diameter ≥ 10 mm at baseline (for lymph nodes, short axis ≥ 15 mm), measurable by chest CT or PET-CT, as long as accurate repeat measurements can be performed.
- ECOG performance status score of 0 or 1.
- Expected survival ≥ 3 months.
- Planned treatment with Serplulimab combined with platinum-based chemotherapy.
- Patients who have previously taken or are currently taking Bayer Aspirin are allowed.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.