入组条件和排除条件:
Inclusion Criteria:入组的条件:
1.Age at least 18 years.18周岁以上
2.Documented evidence of NSCLC (locally advanced, unresectable, Stage III) 必须有经组织学或细胞学方法确定为非小细胞肺癌(且是局部晚期、无法切除之疾病,第III期)
3.Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.患者必须接受至少2个周期以上的含铂类化疗与同步放疗。
4.World Health Organization (WHO) Performance Status of 0 to 1.世界卫生组织体能状态为0或1。
5.Estimated life expectancy of more than 12 weeks.生存期12周以上。
Exclusion Criteria:排除入组的条件:
1.Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.使用过任何PD1或PDL1的免疫疗法。
2.Active or prior autoimmune disease or history of immunodeficiency.没有自身免疫方面的疾病。
3.Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.活动性B型肝炎或C型肝炎患者 ,艾滋病患者。
4.Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris. 不稳定的病情,如充血性心力衰竭症状,失控的高血压或不稳定心绞痛
5.Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.有任何因放疗所引起的,且常见不良事件评估标准(CTCAE)级别>2的毒性反应仍未缓解。
6.Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
活动性或有病史的炎症性肠病(如克罗罗恩病、溃疡性结肠炎等)。
还在招人的医院在美国的亚特兰大,后附医院实验组的链接:
请登录http://www.gwinnettmedicalcenter ... cer-clinical-trials
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入组条件和排除条件:
Inclusion Criteria:入组的条件:
1.Aged at least 18 years 18周岁以上
2.Documented evidence of NSCLC (Stage IIIB/ IV disease)有组织学或细胞学方法确定为非小细胞肺癌(3-4期)
3.Disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of NSCLC. 使用铂类为基础的化疗后,病情有进展,并再使用过其它的治疗方案治疗后的非小细胞肺癌患者。
4.World Health Organization (WHO) Performance Status of 0 or 1世界卫生组织体能状态为0或1。
5.Estimated life expectancy more than 12 weeks生存期12周以上。
Exclusion Criteria:排除入组的条件:
1.Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti CTLA4使用过任何PD1、PDL1或CTLA4的免疫疗法。
2.Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)脑转移或脊髓经过治疗,病情稳定(比如不需要类固醇之类的药)
3.Active or prior documented autoimmune disease within the past 2 years在过去的2年中,活动性自身免疫方面的疾病。
4.Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV。活动性B型肝炎或C型肝炎患者 ,艾滋病患者。
5. Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2 from previous anti-cancer therapy有任何大于2级因治疗癌症所引起的副作用.
6.Known EGFR TK activating mutations or ALK rearrangements。有EGFR突变和ALK突变。
7.Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1. 有任何大于三级以上的与免疫有关的疾病,需要治疗或者有与免疫有关的没有控制的1级以上的副反应。
8.Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
        目前患有,或有证据显示过去曾有活动性或有炎症性肠病(如克罗罗恩病、溃疡性结肠炎等)病史的病人。