NCT06295926

Serplulimab Combined With CCRT for LS-SCLC.

A Single-arm Phase II Clinical Trial of Serplulimab Combined With Concurrent Chemoradiotherapy for Limited-stage Small Cell Lung Cancer(LS-SCLC).

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 cisplatin/carboplatin and concurrent thoracic radiotherapy combined with Surlidumab immunotherapy. Following CCRT+Surlidumab 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.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-04
• Primary completion: 2027-01-25
• Completion: 2027-12-31
• First posted: 2024-03-06
• Last updated: 2024-07-22

Locations

1 site across 1 country: China