Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554535
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
Efficacy and Safety of Serplulimab With Chemotherapy and Aspirin in Untreated Extensive-Stage Small Cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
In 2020 global cancer burden data showed 22 million new cases of lung cancer ranking second with 18 million deaths far surpassing other cancer types and ranking first in cancer-related mortality In 2020 China reported 820000 new cases of lung cancer with 710000 deaths accounting for 238 of all cancer deaths making lung cancer the leading cause of cancer incidence and mortality in the country Small cell lung cancer SCLC originating from neuroendocrine-differentiated epithelial cells accounts for 15-20 of all lung cancers Using the Veterans Administration VA staging system SCLC is classified into limited-stage and extensive-stage disease The majority of patients present with symptoms related to metastatic lesions at diagnosis and only 30-40 are diagnosed at the limited stage Extensive-stage patients due to widespread metastasis and poor physical condition often can only receive supportive care resulting in shorter survival times
Based on theoretical foundations cytotoxic chemotherapy kills tumor cells TC exposing the immune system to high levels of tumor antigens Therefore compared to standard chemotherapy alone activating tumor-specific T-cell immunity by inhibiting the PD-L1PD-1 signaling pathway may provide deeper and more durable responses Recent studies have explored the potential of combining immunotherapy with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer ES-SCLC
Serplulimab is an innovative PD-1 inhibitor developed by Henlius a recombinant humanized IgG4 monoclonal antibody It has characteristics such as structural stability weak antibody-dependent cellular cytotoxicity ADCC and complement-dependent cytotoxicity CDC moderate antibody-dependent cellular phagocytosis ADCP effects large epitope binding area high affinity slow dissociation strong anti-tumor activity and low immunogenicity Clinical studies involving serplulimab combined with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer have been conducted to evaluate its safety and efficacy
Aspirin ASP originally extracted from willow bark is a small molecule compound with various effects such as antipyretic anti-inflammatory analgesic and antiplatelet aggregation In recent years research has discovered new anti-cancer effects of aspirin and it has been confirmed to promote tumor cell apoptosis Additionally preclinical evidence suggests that antiplatelet drugs and immune checkpoint inhibitors ICIs may have potential synergistic effects which warrant further investigation in the context of lung cancer treatment
PD-1 inhibitors as the standard first-line treatment for extensive-stage small cell lung cancer have been proven in numerous studies to have good efficacy and safety Aspirin as a classic anticoagulant has advantages such as safety affordability and easy availability Lung cancer patients are inherently in a hypercoagulable state and if aspirins synergistic anti-tumor effects and its potential to reduce adverse events such as fever and thrombosis can be further confirmed it will have a significant impact on the treatment of ES-SCLC patients potentially achieving enhanced therapeutic effects Therefore we plan to conduct this observational Phase II study to evaluate the efficacy and safety of combining the PD-1 inhibitor serplulimab platinum-based chemotherapy and Bayer aspirin as first-line treatment for extensive-stage small cell lung cancer
Based on theoretical foundations cytotoxic chemotherapy kills tumor cells TC exposing the immune system to high levels of tumor antigens Therefore compared to standard chemotherapy alone activating tumor-specific T-cell immunity by inhibiting the PD-L1PD-1 signaling pathway may provide deeper and more durable responses Recent studies have explored the potential of combining immunotherapy with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer ES-SCLC
Serplulimab is an innovative PD-1 inhibitor developed by Henlius a recombinant humanized IgG4 monoclonal antibody It has characteristics such as structural stability weak antibody-dependent cellular cytotoxicity ADCC and complement-dependent cytotoxicity CDC moderate antibody-dependent cellular phagocytosis ADCP effects large epitope binding area high affinity slow dissociation strong anti-tumor activity and low immunogenicity Clinical studies involving serplulimab combined with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer have been conducted to evaluate its safety and efficacy
Aspirin ASP originally extracted from willow bark is a small molecule compound with various effects such as antipyretic anti-inflammatory analgesic and antiplatelet aggregation In recent years research has discovered new anti-cancer effects of aspirin and it has been confirmed to promote tumor cell apoptosis Additionally preclinical evidence suggests that antiplatelet drugs and immune checkpoint inhibitors ICIs may have potential synergistic effects which warrant further investigation in the context of lung cancer treatment
PD-1 inhibitors as the standard first-line treatment for extensive-stage small cell lung cancer have been proven in numerous studies to have good efficacy and safety Aspirin as a classic anticoagulant has advantages such as safety affordability and easy availability Lung cancer patients are inherently in a hypercoagulable state and if aspirins synergistic anti-tumor effects and its potential to reduce adverse events such as fever and thrombosis can be further confirmed it will have a significant impact on the treatment of ES-SCLC patients potentially achieving enhanced therapeutic effects Therefore we plan to conduct this observational Phase II study to evaluate the efficacy and safety of combining the PD-1 inhibitor serplulimab platinum-based chemotherapy and Bayer aspirin as first-line treatment for extensive-stage small cell lung cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None