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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc. 300mg Q3W
45Gy/3Gy/3week
25Gy/2.5Gy/2week
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, China
RECRUITINGShanxi Province Cancer Hospital
Taiyuan, Shanxi, China
RECRUITINGProgression-free survival
To evaluate the progression-free survival (PFS) of HLX10 (Serplulimab) consolidation therapy after concurrent hypofractionated radiotherapy with chemotherapy in limited-stage small cell lung cancer according to RECIST 1.1 criteria
Time frame: up to 12 months
Overall survival(OS)
Overall survival time is defined as the time from the date of the patient's first dose of HLX10 to the date of any documented death due to any cause.
Time frame: up to 24 months
Objective response rate (ORR)
Proportion of subjects achieving a best response of complete response (CR) and partial response (PR) as assessed by RECIST 1.1.
Time frame: up to 24 months
Time to treatment failure (TTF)
Time to disease progression, death, withdrawal due to adverse events, patient refusal to continue the study, or use of a new treatment from the first HLX10 administration.
Time frame: up to 12 months
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