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

NCT06554535 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: AB20240810
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

ES-SCLC; Chemo-immunotherapy combination; Aspirin

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  The time from the start of treatment until the first documented disease progression or death from any cause, whichever occurs first, as assessed by RECIST criteria (Response Evaluation Criteria in Solid Tumors).

  Up to 2 years

Secondary Outcomes (4)

• Two-Year Overall Survival

  2 years

• Objective Response Rate

  Up to 2 years

• Disease Control Rate

  Up to 2 years

• Incidence of Adverse Events

  Up to 2 years

Study Arms (1)

Serplulimab + Chemotherapy + Aspirin

EXPERIMENTAL

Drug: Serplulimab，Platinum-based Chemotherapy，Aspirin

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.

Serplulimab + Chemotherapy + Aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
• Currently receiving other anticoagulant therapy.
• Previous systemic anti-tumor therapy.
• Contraindications to the use of Serplulimab, Aspirin, or chemotherapy.

Sponsors & Collaborators

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

Related Publications (1)

• Cheng Y, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Dvorkin M, Shi J, Pan Z, Shi J, Wang X, Bai Y, Melkadze T, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Kang W, Wang Q, Zhu J; ASTRUM-005 Study Group. Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer: The ASTRUM-005 Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1223-1232. doi: 10.1001/jama.2022.16464.

  PMID: 36166026 BACKGROUND

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

He Yong, MD

CONTACT

6-23-68757791; eyong8998@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: August 15, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 15, 2024

Record last verified: 2024-08