NCT05443646

Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Limited Stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HLX10	HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. 300mg Q3W
RADIATION	hypofractionated radiotherapy	45Gy/3Gy/3week
RADIATION	Prophylactic Cranial Irradiation (PCI)	25Gy/2.5Gy/2week

Timeline

• Start date: 2022-09-23
• Primary completion: 2024-06-30
• Completion: 2025-06-30
• First posted: 2022-07-05
• Last updated: 2024-05-07

Locations

2 sites across 1 country: China