A Prospective, Open-label, Bayesian Adaptive Randomized Phase II Clinical Study of Toripalimab Combined With Beat Chemotherapy in the Treatment of Advanced Back-line Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 130
- 主要终点
- ORR
研究概览
简要总结
This study is a randomized, open-label, multi-center investigator-initiated clinical trial. Patients who meet the inclusion criteria receive the treatment plan stipulated in the protocol. A Bayesian design is used to explore the efficacy and safety of teprotumumab combined with pulse chemotherapy in the treatment of advanced second-line extensive-stage small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age ≥18 years old, both male and female are acceptable.
- •2. Histology and pathology diagnosis of extensive stage small cell lung cancer, and must meet the following standards:
- •always has not received the immune therapy,
- •Previously received immunotherapy, with the number of treatment lines ≥2 and the immunotherapy being effective(immunotherapy PFS > 3 months, withdrawal time > 3 months)
- •never used anlotinib,
- •3. ECOG: 0 ~ 2;
- •4 . The expected lifetime 12 weeks or more;
- •5. Major organs function normal
排除标准
- •1.Those who are allergic to toripalimab or etoposide or have metabolic disorders;
- •2.With known the special ripley sheet resistance, etoposide contraindication;
- •3.Other circumstances that the researcher assessed as unsuitable for participation in this clinical study.
研究组 & 干预措施
Etoposide
Etoposide: PO, 50 mg, d1-d14, Q3W
干预措施: Toripalimab; Etoposide (Drug)
Etoposide+Toripalimab
Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W；
干预措施: Toripalimab; Etoposide (Drug)
Toripalimab+Etoposide+Anlotinib
Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； Anlotinib: 12mg, d1-d14, PO, Q3W;
干预措施: Toripalimab; Etoposide (Drug)
Toripalimab+Etoposide+Carboplatin
Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； Carboplatin: AUC=5, d1, ivgtt, Q3W
干预措施: Toripalimab; Etoposide (Drug)
Etoposide+Toripalimab+Temozolomide
Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ，Q3W； Temozolomide: 75mg/m ² /d, d1-d21, PO, Q4W;
干预措施: Toripalimab; Etoposide (Drug)
结局指标
主要结局
ORR
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
According to the RECIST 1.1 standard, the proportion of patients whose tumors have shrunk to a complete response (CR) or partial response (PR) and have maintained this condition for at least 4 weeks
次要结局
未报告次要终点