Serplulimab Combined With CCRT for LS-SCLC.
NCT06295926 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2024-07-22
Summary
Small cell lung cancer(SCLC) 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.
Conditions
Interventions
- DRUG
-
Serplulimab
Undergo 4 cycles of synchronous radiotherapy and chemotherapy combined with Sintilimab immunotherapy, followed by Sintilimab monotherapy for maintenance treatment until disease progression or up to 1 year.
Sponsors & Collaborators
-
Peking Union Medical College Hospital
lead OTHER
Principal Investigators
-
Mengzhao Wang, MD · Peking Union Medical College Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-04
- Primary Completion
- 2027-01-25
- Completion
- 2027-12-31
Countries
- China
Study Locations
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