NCT04167657Unknown2 期
A Phase II Single-arm Study of Sintilimab After Thoracic Radiation in Previously Treated Advanced NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a single-arm phase II study, to investigator the efficacy and safety of sintilimab after radiation in advanced NSCLC, who had failed first line systemic 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent;
- •Age ≥ 18 years ;
- •Histologically or cytologically confirmed NSCLC, without EGFR sensitive mutation (must) or no known ALK/ROS1 positive;
- •Stage IIIB-IV (AJCC 8th edition) or recurrent/progressive disease after multidisciplinary treatment for local advanced disease;
- •Patients must have disease progression or recurrence after receiving first line systemic therapy for advanced or metastasis disease: 1) Maintenance therapy after platinum based chemo-doublet shall not be considered as a separated treatment regimen, 2)Patients who had received neo-adjuvant/adjuvant therapy or radical chemo- radiotherapy for local advanced disease and relapsed after 6 month or later, must have failed first line treatment for recurrent disease before enrollment;
- •ECOG PS 0-1, with expected survival over 3 months;
- •Patients shall have at least one leision eligible for radiation, e.g. bone metastasis, intrapulmonary node, adrenal disease, etc. Patient must have at least one disease (other than radiation target) according to RECIST 1.1: 1) Patient must have received radiation for 1 location after disease progression or recurrence after first line treatment for advanced or metastasis disease, 2) Time between first dose of sintilimab and last radiation shall be no longer than 3 weeks
- •Adequate marrow and organ function as per baseline CBC/CMP/Urine test;
- •Prior anti-tumor therapy should be completed at least 4 weeks before enrollment, and adverse events of prior treatment shall be return to ≤G1 per CTCAE (except for alopecic or any non-clinical significant laboratory abnormalities) ;
- •Women with childbearing potential or men whose female partners are with childbearing potential must agree to use efficient contraceptive methods during the study treatment period until 90 days after last dose of study treatment.
排除标准
- •Previously treated by any immune therapy;
- •Active infection including HBV, HCV, and HIV;
- •Serious marrow or organ malfunction, e.g. hepatic or renal dysfunction;
- •Patients with unstable CNS metastasis or require corticosteroids to control CNS symptoms. Patients with stable brain metastasis after radiation (3 weeks) will be eligible;
- •Active or autoimmune disease;
- •ILD, including drug-induced ILD, radiation pneumonia that required corticosteroids, or any clinical implication for active ILD;
- •Any course that lead to treatment with continuous systemic corticosteroids >10 mg/day prednisone or equivalent dose of other steroids;
- •Pregnant or lactating women.
研究组 & 干预措施
Arm1
Experimental
Sintilimab monotherapy every 3 weeks, after a radiation targeting a single location no less than dose 30Gy( 6 Gy × 5, or other ), or the planned dose could reach 30 Gy.
干预措施: Sintilimab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Time Frame: up to 12 months after enrollment or study close
ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion of patients with a complete response (CR) or partial response (PR) as their best respons ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion of patients with a complete response (CR) or partial response (PR) as their best respons
次要结局
未报告次要终点
研究者
Wang mengzhao
Professor
Peking Union Medical College Hospital
研究点 (1)
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