NCT04106180Unknown2 期
An Open-label, Multicenter, Phase II Single Arm Trial of SBRT in Combination With Sintilimab and GM-CSF for the Treatment of 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
- 63
- 试验地点
- 1
- 主要终点
- Overall Objective Response Rate
研究概览
简要总结
This study is an open-label, multicenter, phase II single arm trial to evaluate the efficacy and safety of SBRT in combination with sintilimab and GM-CSF for the treatment of patients with advanced NSCLC.
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
- •Age at least 18 years.
- •ECOG PS 0-
- •Pathologically confirmed stage IV NSCLC.
- •Negative for driver genes including EGFR，ALK，and ROS-
- •Patients with disease progression after first-line platinum-based therapy without anti-PD-1 or PD-L1 treatment.
- •Patients with at least one lesion (size 1-5cm) eligible for SBRT (24Gy/3Fx) and simultaneously at least one measurable lesion (in addition to the lesion treated with SBRT) as defined by RECIST1.
- •Patients with brain metastasis are eligible if they are asymptomatic, neurologically stable, and off corticosteroids.
- •Life expectancy of more than 3 months.
- •Patients with no indications for palliative radiotherapy in the opinion of the investigator.
- •Patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery.
- •Signed informed consent for the use of fresh tumor biopsies before and during the treatment.
- •Women of childbearing age and men must agree to use effective contraception during the trial.
- •Adequate organ function within 1 week prior to the enrollment：
- •Adequate bone marrow function: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 * 10 ^ 9/L or neutrophil count ≥ 1.5 * 10 ^ 9/L, and platelet count ≥ 100 * 10 ^ 9/L;
- •Adequate hepatic function: total bilirubin < 1.5 x upper limit of normal (ULN). Note: If total bilirubin is > 1.5 x ULN, direct bilirubin must ≤ ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 ULN;
- •Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min;
- •Ability to understand and willingness to provide the informed consent.
排除标准
- •Prior exposure to immunomodulatory agent,including but limited to anti-PD-1 or anti-PD-L1 antibodies.
- •Severe autoimmune disease: inflammatory bowel disease (including Crohn's disease and ulcerative colitis) 、rheumatoid arthritis、scleroderma、systemic lupus erythematosus 、Wegener's granulomatosis and related vasculitides.
- •Patients receiving non-platinum-based chemotherapy as first-line treatment
- •Mixed small cell with non-small cell lung cancer histology.
- •Pregnant or lactating women.
- •Symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis.
- •History of any other malignancy.
- •Patients in whom palliative radiotherapy is indicated in the opinion of the investigator.
- •Active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia.
- •Prior allergic reaction or contraindications to sintilimab and GM-CSF.
- •Patients who have received tumor vaccine; or administration of live, attenuated vaccine within 4 weeks before the start of treatment. Note: Influenza vaccination is permitted only during influenza season, while live, attenuated influenza vaccine such as FluMist is not allowed.
- •Patients receiving concurrent chemotherapy drugs,other immunosuppressive agents,or other investigational treatment.Long-term corticosteroid users are also excluded.
- •Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
研究组 & 干预措施
SBRT + sintilimab + GM-CSF
Experimental
干预措施: GM-CSF (Drug)
SBRT + sintilimab + GM-CSF
Experimental
干预措施: Sintilimab (Drug)
SBRT + sintilimab + GM-CSF
Experimental
干预措施: SBRT (Radiation)
结局指标
主要结局
Overall Objective Response Rate
时间窗: At least 6 weeks after start of treatment
ORR was defined as the proportion of participants with partial response (PR) or complete response (CR) to treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
次要结局
- Percentage of Participants With Adverse Events(Two years)
- Objective Response Rate (ORR) in Non-irradiated Lesion(At least 6 weeks after start of treatment)
- Overall Survival(Two years)
- Progression Free Survival(Two years)
研究者
研究点 (1)
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