招募患者：AZD9291治疗局部晚期或转移性非小细胞肺癌的开放、单臂临床研究

2015-09-09 MedSci MedSci原创

1. 试验药物简介 AZD9291是一种口服的、不可逆的、第三代EGFR抑制剂（EGFR-TKI），对已有EGFR-TKI有抗性和T790M突变的NSCLC患者有较佳的治疗效果。 2. 试验目的用客观缓解率（ORR）评估AZD9291 的疗效。采用研究者的RECIST1.1 评估结果，对ORR 开展敏感性分析。 3.

1. 试验药物简介

AZD9291是一种口服的、不可逆的、第三代EGFR抑制剂（EGFR-TKI），对已有EGFR-TKI有抗性和T790M突变的NSCLC患者有较佳的治疗效果。

2. 试验目的

用客观缓解率（ORR）评估AZD9291 的疗效。采用研究者的RECIST1.1 评估结果，对ORR 开展敏感性分析。

3. 试验设计

试验分类：安全性和有效性

试验分期： II期

设计类型：单臂试验

随机化：非随机化

盲法：开放

试验范围：国际多中心试验

目标入组人数：国际多中心试验:总体175人，中国120人

4. 入选标准

1 用客观缓解率（ORR）评估AZD9291 的疗效。采用研究者的RECIST1.1评估结果，对ORR 开展敏感性分析。

2 男性或女性，年龄不小于18岁。研究只入选来自亚太地区的患者。

3 患者经组织学或细胞学确诊为NSCLC。

4 肿瘤为局部晚期或转移性NSCLC，已不适合开展根治性手术或放疗。

5 入组研究前最后一次治疗时有疾病进展的影像学依据：进展之前只接受过一线EGFR TKI治疗，再无其他治疗或者进展之前，接受过EGFR-TKI和含铂双药联合化疗（不考虑用药顺序）。既往治疗线数可以超过1线。

6 从最初诊断开始后的任意时间，有明确记录的已证实的与EGFR TKI敏感性相关的EGFR突变（包括G719X，外显子19缺失，L858R，L861Q）。

7 根据中心实验室检查最近一次治疗期间疾病进展后采集的活检样本确认，肿瘤必须T790M突变阳性。

8 世界卫生组织（WHO）体力状况0-1分，而且研究前2周无恶化，预期寿命不少于12周。

9 患者至少有1个基线时肿瘤病灶能够满足下列要求：既往未经过照射，也未用于研究筛选期活检，并且可以准确测量，基线期最长径>=10mm（如果是淋巴结，要求短轴>=15mm），测量方法可以是计算机化断层显像（CT），也可以是磁共振成像（MRI），只要能够准确完成重复测量即可。

10 如果是有生育能力的女性，应当采取充分的避孕措施，不得母乳喂养，给药前妊娠试验阴性；如果是无生育能力的女性，筛选期必须满足下列标准之一：？绝经后女性，指年龄50岁以上，并且撤停外源性激素治疗之后，已停经至少12个月；？ 50岁以下女性，只要撤停外源性激素治疗之后已停经12个月以上，并且LH和FSH水平处于研究机构的绝经后参考范围，即为绝经后状态；？已行子宫切除术、双侧卵巢切除术、双侧输卵管切除术等不可逆的绝育手术，但不包括输卵管结扎术。

11 男性受试者愿意采取屏障避孕措施，即避孕套。

12 研究患者参加可选遗传学研究，必须：提供遗传学研究的知情同意书。

5. 排除标准

1 患者参与了研究计划的制定和实施（适用于阿斯利康公司员工及研究中心人员）

2 接受过下列任何一项治疗：从EGFR-TKI（如厄洛替尼、吉非替尼、埃克替尼、阿法替尼）治疗到研究治疗首次给药，时间不超过8天或5个半衰期（取时间长者）。（因为给药方案的原因，没有充分达到洗净期的患者，可以经阿斯利康公司与研究者协商一致后，根据已知半衰期及药物相关不良事件的逆转时间，另外确定适当的洗净期）；在研究治疗首次给药前14天内，患者曾在前一治疗方案或临床研究中使用过细胞毒性化疗药物、试验性药物或其他抗癌药物；？曾使用过AZD9291或第三代EGFRTKI类药物（如CO-1686）；研究治疗首次给药前的4周内，曾行重大手术（不包括血管通路建立操作）；患者正在使用（或者在研究治疗首次给药前1周内无法停用）的某些药物或草药补充剂，已知是CYP3A4的强抑制剂或诱导剂；停用其他试验性药物的时间不到该药的5个半衰期。

3 研究治疗开始时，既往治疗仍有未愈毒性反应，并且《不良事件通用术语标准（CTCAE）》级别超过1级，但是脱发除外，既往铂类治疗相关神经病变可以放宽到2级。

4 脊髓压迫或脑转移，无症状、病情稳定、研究治疗开始前不需要使用类固醇药物治疗满4周者除外。

5 有任何提示患有重度或未控制的全身性疾病的临床依据，例如研究者认为患者不适合参加试验或者会影响患者对研究方案依从性的未控制高血压患者和活动性易出血体质患者，另外还有活动性感染，如乙型肝炎、丙型肝炎、人类免疫缺陷病毒（HIV）感染。筛选期不要求排查慢性疾病。然而，对参与生物标志物/遗传研究和来自于中国境外的患者而言，需要出于样本运输的目的进行HBV、HCV以及HIV检验，并且结果须为阴性。

6 难以控制的恶心和呕吐，慢性胃肠疾病，患者无法吞咽药品制剂，曾行大范围肠切除术，可能影响AZD9291的充分吸收。

7 符合下列任一心脏标准：在静息状态下，3次心电图（ECG）检查得出的平均校正QT间期（QTc）>470 msec。各种有临床意义的心律、传导、静息ECG形态异常，例如完全性左束支传导阻滞，III度传导阻滞，II度传导阻滞，PR间期>250 msec。可能增加QTc延长风险或心律失常事件风险的各种因素，例如心力衰竭，低钾血症，先天性长QT综合症，家族史中一级亲属有长QT综合征或不到40岁就不明原因猝死，可能延长QT间期的各种合并用药。

8 有下列既往史：间质性肺病，药物性间质性肺病，需要类固醇治疗的放射性肺炎，临床上有活动的间质性肺病。

9 骨髓储备或器官功能不足，达到下列实验室数值：性粒细胞绝对值 <1.5 x 109/L ；血小板数 <100 x 109/L；红蛋白<90 g/L；若无明确的肝转移，丙胺酸氨基转移酶（ALT）> 2.5倍正常上限（ULN），若有肝转移，丙胺酸氨基转移酶> 5倍ULN；若无明确的肝转移，天门冬氨酸氨基转移酶（AST）> 2.5倍ULN，若有肝转移，天门冬氨酸氨基转移酶> 5倍ULN；若无肝转移，总胆红素> 1.5倍ULN，若有明确的Gilbert综合症（非结合型高胆红素血症）或肝转移，总胆红素> 3倍ULN；肌酐>1.5倍ULN，同时伴有肌酐清除率< 50 ml/min（实测值，或者Cockcroft-Gault公式计算值）；只有当肌酐> 1.5倍ULN时，才需要检查肌酐清除率进行确认。

10 患者有对AZD9291活性成分或非活性辅料，化学结构与AZD9291类似的药物或AZD9291同类药物发生超敏反应的病史。

11 男性或女性有生育能力但未采取有效避孕措施的，女性已妊娠或母乳喂养，或者进入研究前妊娠试验阳性（尿或血清）的。

12 因为患者不愿意遵守研究的各项流程、限制和要求，经研究者判定患者不应参加研究的。

13 曾行同种异体骨髓移植。

14 采集遗传学样本之前的120天内，输注过未去白细胞的全血。

15 患者还有其他并存恶性肿瘤或最近5年内诊断过其他恶性肿瘤，基底细胞癌和原位宫颈癌除外。

6. 研究者信息

序号	机构名称	主要研究者	国家	省（州）	城市
1	上海市肺科医院	周彩存	中国	上海	上海
2	广东省人民医院	周清	中国	广东	广州
3	中山大学附属肿瘤医院	张力	中国	广东	广州
4	北京大学肿瘤医院	王洁	中国	北京	北京
5	浙江大学附属第一医院	周建英	中国	浙江	杭州
6	吉林省肿瘤医院	程颖	中国	吉林	长春
7	四川大学华西医院	卢铀	中国	四川	成都
8	西南医院	周向东	中国	重庆	重庆
9	大坪医院	何勇	中国	重庆	重庆
10	山东省肿瘤医院	王哲海	中国	山东	济南
11	哈尔滨医科大学附属肿瘤医院	陈公琰	中国	黑龙江	哈尔滨
12	浙江省肿瘤医院	范云	中国	浙江	杭州
13	复旦大学附属肿瘤医院	常建华	中国	上海	上海
14	江苏省肿瘤医院	史美琪	中国	江苏	南京
15	河南省肿瘤医院	赵燕秋	中国	河南	郑州
16	中国医学科学院肿瘤医院	石远凯	中国	北京	北京
17	海南省人民医院	黄奕江	中国	海南	海口
18	北京肿瘤医院	方健	中国	北京	北京
19	西安唐都医院	张贺龙	中国	陕西	西安
20	北京协和医院	王孟昭	中国	北京	北京
21	解放军307医院	高红军	中国	北京	北京
22	武汉协和医院	武钢	中国	湖北	武汉
23	福建省肿瘤医院	黄诚	中国	福建	福州
24	杭州市第一医院	马胜林	中国	浙江	杭州
25	武汉同济医院	陈圆	中国	湖北	武汉
26	西京医院	张艰	中国	陕西	西安

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2017-06-23 1e145228m78(暂无匿称)

学习了，谢谢作者分享!

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2017-05-17 130****4638

看过了谢谢分享

96 0
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2016-04-11 12498e5fm22(暂无昵称)

#AZ#

56 0
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2016-01-15 lingaifan

#非小细胞#

60 0
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2016-01-29 yhy100208

#局部晚期#

76 0
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topicList=[TopicDto(id=3083, encryptionId=b6233083df, topicName=AZD9291)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4f2c2500194, createdName=446798725_87912765, createdTime=Tue Jul 26 03:02:00 CST 2016, time=2016-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=38226, encodeId=8493382265d, content=这有一患者想参加，不知道怎么联系？, beContent=null, objectType=article, channel=null, level=null, likeNumber=155, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=db451654645, createdName=云烟666, createdTime=Thu Oct 08 17:14:00 CST 2015, time=2015-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386167, encodeId=2607138616ecb, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Fri Sep 11 13:02:00 CST 2015, time=2015-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405679, encodeId=4ad414056e902, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Fri Sep 11 13:02:00 CST 2015, time=2015-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1471992, encodeId=d4bd14e199252, content=<a href='/topic/show?id=c4d79344044' target=_blank style='color:#2F92EE;'>#转移性非小细胞肺癌#</a>, 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2016-07-26 446798725_87912765

#AZD9291#

50 0
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2015-10-08 云烟666

这有一患者想参加，不知道怎么联系？

155 0
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topicList=[TopicDto(id=3083, encryptionId=b6233083df, topicName=AZD9291)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4f2c2500194, createdName=446798725_87912765, createdTime=Tue Jul 26 03:02:00 CST 2016, time=2016-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=38226, encodeId=8493382265d, content=这有一患者想参加，不知道怎么联系？, beContent=null, objectType=article, channel=null, level=null, likeNumber=155, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=db451654645, createdName=云烟666, createdTime=Thu Oct 08 17:14:00 CST 2015, time=2015-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386167, encodeId=2607138616ecb, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, 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2015-09-11 1249842em09(暂无昵称)

#转移性#

71 0
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2015-09-11 chg122

#局部#

70 0
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2015-09-11 anan

#转移性非小细胞肺癌#

51 0

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招募患者：AZD9291治疗局部晚期或转移性非小细胞肺癌的开放、单臂临床研究

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招募患者：AZD9291治疗局部晚期或转移性非小细胞肺癌的开放、单臂临床研究

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