Sequential Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated with Chemo-immunotherapy Followed by PD-1/PD-L1 Inhibitor Maintenance Therapy：a Phase II, Single Arm, Prospective Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- progression-free survival rate at 6-month
研究概览
简要总结
This is an open-label, single arm Phase II study designed to observe and evaluate the efficacy and safety of sequential thoracic radiotherapy in the first-line treatment of extensive small cell lung cancer with chemotherapy combined with approved PD-1/PD-L1 inhibitors.
详细描述
This study a single arm prospective phase II study. All the enrolled patients will be patients with ES-SCLC who did not have PD after 4-6 cycle of platinum-based chemotherapy in combination with an PD-1/PD-L1 inhibitors. Then, those enrolled patients would be treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy.
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 between18 years and 75 years.
- •Histologic or cytologic confirmation of extensive-stage small cell lung cancer.
- •Initially treated patients with extensive SCLC showed no disease progression after 4-6 cycles of chemotherapy combined with PD-1/PD-L1 inhibitors.
- •Presence of at least one measurable lesion (according to RECIST v1.1).
- •ECOG performance status of 0 or
- •Life expectancy of at least 3 months.
- •Adequate bone marrow, liver and kidney function.
- •Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value
排除标准
- •Previous T cell co-stimulation or immune checkpoint therapy.
- •Previous received chemoradiotherapy for limited-stage SCLC.
- •Central nervous system metastasis with clinical symptoms.
- •Multiple liver metastases (patients with isolated liver metastases, metastatic lesions < 3cm could be included).
- •Patients with spinal cord compression.
- •Idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia during screening (patients with active pulmonary tuberculosis couldn't be enrolled).
- •Have received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the informed consent.
- •In the 5 years prior to the study, subjects had prior or concurrent malignancies requiring active treatment.
- •Subjects with any severe and/or uncontrolled disease (hypertension, heart disease, infection, cirrhosis, active hepatitis, AIDS, third space effusion).
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •Severe allergic reactions to any of the monoclonal antibodies are known to occur.
结局指标
主要结局
progression-free survival rate at 6-month
时间窗: 12 months after last patient entry
PFS is defined as the period from the start of receiving the first line chemotherapy plus PD-1/PD-L1 inhibitor to disease progression.
次要结局
未报告次要终点