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Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

Limited Stage Small Cell Lung Cancer Clinical Trial

Official title:
A Phase II Study of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer

Clinical Trial Summary

This study is a multi-center, Single-arm Phase II study to evaluate the clinical efficacy and safety of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer

Clinical Trial Description

All eligible patients after screening will receive up to four cycles chemotherapy. Recommended regimens are etoposide 100 mg/m2 intravenously on day 1-3 in combination with cisplatin 75 mg/m2 intravenously on day 1 or carboplatin AUC=5 every 3 weeks. A total of 45Gy in 15 fractions over 3 weeks will be delivered. PCI is routinely scheduled for patients without progression after chemoradiotherapy, and hippocampal avoidance is highly recommended. 25Gy in 10 fractions over 2 weeks to the brain will be prescribed. Intensity modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT) technique are required. Patients without disease progression will receive an intravenous infusion of serplulimab 300mg every 3 weeks. Treatment of serplulimab should be continued until disease progression, intolerable toxicity, withdrawal of consent, or to a maximum of 1 year. Continuation of immunotherapy after disease progression is acceptable per investigators' discretion. The investigator and IRRC respectively assess the tumor images according to RECIST 1.1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05443646
Study type Interventional
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact Nan Bi, Doctor
Phone 86010-87788799
Email binan_email@163.com
Status Recruiting
Phase Phase 2
Start date September 23, 2022
Completion date June 30, 2025
View Details
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