A Phase II Study of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Progression-free survival
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years; ECOG score 0-
- •Histologically or cytologically confirmed small cell lung cancer.
- •Limited stage, defined as the tumor confined to one side of the thoracic cavity including ipsilateral hilar, bilateral mediastinal, and bilateral supraclavicular lymph nodes, (metastatic lymph nodes are defined as short diameter ≥ 1 cm or increased metabolism on PET-CT considering metastatic lymph nodes); unless cytologically confirmed malignant pleural effusion, the thickness of pleural effusion on chest CT is less than 1 cm; (stage I-IIIB without intrapulmonary metastasis in the 7th edition of AJCC staging in 2009) .
- •No other previous anti-tumor history, at least 3 months of expected survival.
- •No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.
排除标准
- •Histologically or cytologically confirmed mixed SCLC.
- •Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included.
- •Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy.
- •Patients with other active malignancies within 5 years or at the same time.
- •Subjects with known history of severe allergy to any monoclonal antibody.
- •Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.
- •In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.
研究组 & 干预措施
HLX10 (Serplulimab) Consolidation After Chemotherapy Concurrent Hypofractionated Radiotherapy
Participants will receive at least 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) concurrently with Hypofractionated Radiotherapy, followed by HLX10 300 mg every 3 weeks (Q3W) with maximum 1 years or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
干预措施: HLX10 (Drug)
HLX10 (Serplulimab) Consolidation After Chemotherapy Concurrent Hypofractionated Radiotherapy
Participants will receive at least 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) concurrently with Hypofractionated Radiotherapy, followed by HLX10 300 mg every 3 weeks (Q3W) with maximum 1 years or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
干预措施: hypofractionated radiotherapy (Radiation)
HLX10 (Serplulimab) Consolidation After Chemotherapy Concurrent Hypofractionated Radiotherapy
Participants will receive at least 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) concurrently with Hypofractionated Radiotherapy, followed by HLX10 300 mg every 3 weeks (Q3W) with maximum 1 years or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
干预措施: Prophylactic Cranial Irradiation (PCI) (Radiation)
结局指标
主要结局
Progression-free survival
时间窗: up to 12 months
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
次要结局
- Overall survival(OS）(up to 24 months)
- Objective response rate (ORR)(up to 24 months)
- Time to treatment failure (TTF)(up to 12 months)