Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295926
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-01-27
Brief Title:
Serplulimab Combined With CCRT for LS-SCLC
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Single-arm Phase II Clinical Trial of Serplulimab Combined With Concurrent Chemoradiotherapy for Limited-stage Small Cell Lung CancerLS-SCLC
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Small cell lung cancerSCLC has a poor prognosis and a relatively short overall survival time urgently requiring innovative treatment strategies to improve the prognosis of such patients Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer ES-SCLC Studies have found that compared to chemotherapy alone the combination of Surlidumab with carboplatin and etoposide can extend the median overall survival in ES-SCLC to over 15 months However to date research on the use of immunotherapy in combination with concurrent chemoradiotherapy CCRT in limited-stage small cell lung cancer LS-SCLC remains limited This study aims to explore the clinical benefits of Surlidumab in combination with concurrent chemoradiotherapy in LS-SCLC and evaluate the safety of immunotherapy in combination with CCRT as first-line treatment for LS-SCLC At the same time it seeks to identify tumor-related biomarkers that can effectively predict the efficacy of immunotherapy and prognosis
Detailed Description:
The study plans to include a total of 96 patients who will receive first-line treatment consisting of 4 cycles of etoposide plus cisplatincarboplatin and concurrent thoracic radiotherapy combined with Surlidumab immunotherapy Following CCRTSurlidumab treatment patients will undergo Surlidumab consolidation therapy until disease progression or for a duration of at least 1 year The study aims to evaluate the progression-free survival PFS and overall survival OS of patients compared to those receiving concurrent chemoradiotherapy alone and to explore the efficacy of immunotherapy in limited-stage small cell lung cancer Additionally peripheral blood samples will be collected before treatment and 1 month after CCRT to explore tumor efficacy-related biomarkers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None