登记号
CTR20131407
相关登记号
CTR20131408; CTR20131406; CTR20131404; CTR20131403; CTR20130095
曾用名
药物类型
化学药物
临床申请受理号
企业选择不公示
适应症
非小细胞肺癌
试验通俗题目
阿法替尼与厄洛替尼比较作为治疗肺鳞癌的临床试验
试验专业题目
阿法替尼与厄洛替尼对照在晚期肺鳞状细胞癌患者一线含铂化疗之后作为二线治疗给药的随机开放临床III 期研究
试验方案编号
1200.125
方案最近版本号
版本日期
方案是否为联合用药
企业选择不公示
申请人信息
申请人名称
联系人姓名
勃林格殷格翰 临床试验信息公示组
联系人座机
+862152883966
联系人手机号
联系人Email
MEDCTIDgroup.CN@boehringer-ingelheim.com
联系人邮政地址
中国上海南京西路1601号越洋广场29楼
联系人邮编
200040
临床试验信息
试验分类
安全性和有效性
试验分期
III期
试验目的
通过观察无进展生存期（PFS）比较阿法替尼与厄洛替尼作为肺鳞状细胞癌患者二线治疗的有效性。
随机化
随机化
盲法
开放
试验范围
国际多中心试验
设计类型
平行分组
年龄
18岁(最小年龄)至
N/A岁(最大年龄)
性别
男+女
健康受试者
无
入选标准
- 鳞状组织学晚期NSCLC诊断。
- 完成以铂类为基础的双联化疗作为IIIB/IV期非小细胞肺癌的一线治疗。
- 研究者认为适合接受二线治疗。
- 根据RECIST1.1有可测量病灶。
- 适当的体力状态。
- 可获得用于相关研究的肿瘤组织材料。可以接受存档的肿瘤组织。
- 适当的器官功能。
- 年龄≥ 18 岁。
- 签署了符合 ICH - GCP 指导原则的书面知情同意书。
排除标准
- 先前接受表皮生长因子受体靶向的小分子或抗体的治疗。
- 随机化前 4 周内放疗。
- 活动性的脑转移。
- 任何当下存在其他的恶性肿瘤或过去3 年内诊断过其他的恶性肿瘤（皮肤基底细胞癌、原位宫颈癌、原位前列腺癌除外）。
- 已知的预先存在的间质性肺病。
- 重大或近期的以腹泻为主要症状的急性胃肠疾病。
- 同时存在任何其他严重的疾病或器官系统功能障碍，根据研究者的意见，可能损害患者的安全性或干扰试验药物的安全性评估。
- 有生育能力的女性和男性，进入研究之前不愿意在参与研究期间和治疗结束后至少2个月期间内禁欲或使用适当的避孕措施。
- 有生育能力的女性患者（请参见章节4.2.2.3）：a. 哺乳期，b. 怀孕，c. 不使用或不愿意在参与研究期间内使用适当的避孕措施或不愿意进行方案要求的孕检。
- 活动性乙型肝炎病毒感染（定义为出现Hep B DNA）、活动性丙型肝炎病毒感染（定
- 根据研究者的意见，是已知的或疑似的活性药物或酒精滥用。
- 对阿法替尼或厄洛替尼的治疗有任何禁忌。
- 已知对厄洛替尼、阿法替尼或试验药物的任何辅药过敏。
- 开始研究治疗前4 周内大手术。
- 在此之前参与过阿法替尼临床研究，即使不分配给其阿法替尼。
- 随机化前 4 周内使用任何研究药物（除非地方性法规或研究性产品的指导原则要求更
- 患者没有出现疾病进展。
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:阿法替尼
|
用法用量:剂型： 膜衣片
规格： 50mg、40 mg、30 mg 和20 mg 膜衣片（膜衣片中阿法替尼的剂量为等当量的阿法替尼游离碱的量）
剂量： 每日一次
给药途径： 口服（吞服）
|
|
中文通用名:阿法替尼
|
用法用量:剂型： 膜衣片
规格： 50mg、40 mg、30 mg 和20 mg 膜衣片（膜衣片中阿法替尼的剂量为等当量的阿法替尼游离碱的量）
剂量： 每日一次
给药途径： 口服（吞服）
|
|
中文通用名:阿法替尼
|
用法用量:剂型： 膜衣片
规格： 50mg、40 mg、30 mg 和20 mg 膜衣片（膜衣片中阿法替尼的剂量为等当量的阿法替尼游离碱的量）
剂量： 每日一次
给药途径： 口服（吞服）
|
|
中文通用名:阿法替尼
|
用法用量:剂型： 膜衣片
规格： 50mg、40 mg、30 mg 和20 mg 膜衣片（膜衣片中阿法替尼的剂量为等当量的阿法替尼游离碱的量）
剂量： 每日一次
给药途径： 口服（吞服）
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:厄洛替尼
|
用法用量:剂型： 膜衣片
规格： 150 mg、100mg、25mg 膜衣片（163.9 mg、109.3 mg 和27.3 mg的盐酸厄洛替尼的剂量规格，分别相当于150 mg、100mg、25mg 规格的厄洛替尼）
剂量： 每日一次
给药途径： 口服（吞服）
）
|
|
中文通用名:厄洛替尼
|
用法用量:剂型： 膜衣片
规格： 150 mg、100mg、25mg 膜衣片（163.9 mg、109.3 mg 和27.3 mg的盐酸厄洛替尼的剂量规格，分别相当于150 mg、100mg、25mg 规格的厄洛替尼）
剂量： 每日一次
给药途径： 口服（吞服）
|
|
中文通用名:厄洛替尼
|
用法用量:剂型： 膜衣片
规格： 150 mg、100mg、25mg 膜衣片（163.9 mg、109.3 mg 和27.3 mg的盐酸厄洛替尼的剂量规格，分别相当于150 mg、100mg、25mg 规格的厄洛替尼）
剂量： 每日一次
给药途径： 口服（吞服）
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 通过RECIST1.1测定的无进展生存期 | 18个月 | 有效性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 总生存期 | 3年 | 有效性指标 |
数据安全监察委员会（DMC）
有
为受试者购买试验伤害保险
有
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| 陆舜 | 教授 | 021-62821990-61501 | lushun@csco.org.cn | 中国上海淮海西路241号 上海市胸科医院 | 200030 | 上海市胸科医院 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 上海市胸科医院 | 陆舜 | 中国 | 上海 | 上海 |
| 南京八一医院 | 秦叔逵 | 中国 | 江苏 | 南京 |
| 北京医院 | 程刚 | 中国 | 北京 | 北京 |
| 吉林大学附属第一医院 | 李薇 | 中国 | 吉林 | 长春 |
| 中山大学肿瘤防治中心 | 张力 | 中国 | 广东 | 广州 |
| 中南大学湘雅医院 | 胡成平 | 中国 | 湖南 | 长沙 |
| 北京肿瘤医院 | 王洁 | 中国 | 北京 | 北京 |
| 上海肺科医院 | 周彩存 | 中国 | 上海 | 上海 |
| 江苏省肿瘤医院 | 冯继锋 | 中国 | 江苏 | 南京 |
| Cancer Care of North Florida, PA | Waseemullah Khan | United States of America | FL | Lake City |
| North Shore Hematology Oncology | Ira Oliff | United States of America | IL | Skokie |
| St. Joseph's Mercy Clinic, Inc | Manjusha Kota | United States of America | AZ | Hot Springs |
| Queens Medical Associates | Barry Kaplan | United States of America | NY | Fresh Meadows |
| Spartanburg Regional Medical Center | Charles Bowers | United States of America | SC | Spartanburg |
| Sutter Medical Group | Deepti Behl | United States of America | CA | Sacramento |
| Cancer Therapy & Research @ UTHSCSA | Athanassios Argiris | United States of America | TX | San Antonio |
| Cleveland Clinic | Nathan Pennell | United States of America | OH | Cleveland |
| Karmanos Cancer Institute | Shirish Gadgeel | United States of America | MI | Detroit |
| University of Louisville-James Graham Brown Cancer Center | Goetz Kloecker | United States of America | KY | Louisville |
| Kaiser Permanente Northwest Region | Mark Rarick | United States of America | OR | Portland |
| Moores UC San Diego Cancer Center | Lyudmila Bazhenova | United States of America | CA | La Jolla |
| Lahey Clinic | Paul Hesketh | United States of America | MA | Burlington |
| Ohio State University | Gregory Otterson | United States of America | OH | Columbus |
| Blue Ridge Cancer Care | Jerome Goldschmidt | United States of America | VA | Christianburg |
| Cancer Center of Acadiana | Salman Malad | United States of America | IN | Lafayette |
| Paris Cancer Center (PCC) Texas Oncology | Sucharu Prakash | United States of America | TX | Paris |
| Washington University | Maria Baggstrom | United States of America | MO | St. Louis |
| Fletcher Allen Health Care Inc. | Farrah Khan | United States of America | VT | Burlington |
| SUNY Upstate Medical University | Stephen Graziano | United States of America | NY | Syracuse |
| Oncology Hematology Associates of Northern Pennsylvania, PC | Carmine Marchioli | United States of America | PA | DuBois |
| Illinois Cancer Specialists | Leonard Klein | United States of America | IL | Niles |
| Memorial Healthcare System | Luis Raez | United States of America | FL | Hollywood |
| Boca Raton Regional Hospital-Lynn Cancer Institute | Edgardo Santos | United States of America | FL | Boca Raton |
| Cancer Center of Cookeville Regional Medical Center | Paul Jacquin | United States of America | TN | Cookeville |
| Montefiore Medical Center | Bilal Piperdi | United States of America | NY | Bronx |
| Mid Ohio Oncology/Hematology, Inc | Taral Patel | United States of America | OH | Columbus |
| Commonwealth Hematology-Oncology, PC | Pedro Sanz-Altamira | United States of America | MA | Lawrence |
| Ironwood Cancer & Research Centers | Sujith Kalmadi | United States of America | AZ | Chandler |
| Virginia Oncology Associates | John Paschold | United States of America | VA | Norfolk |
| Billings Clinic Cancer Center | Jorge Nieva | United States of America | MT | Billings |
| Temple University Cancer Center | Deric Savior | United States of America | PA | Philadelphia |
| Thomas Jefferson University | Rita Axelrod | United States of America | PA | Philadelphia |
| West Jefferson General Hospital and Cancer Clinic | Nagarajan Chandrasekaran | United States of America | LA | Marrero |
| Montifiore Medical Center | Bilal Piperdi | United States of America | NY | Bronx |
| Ottawa Hospital Regional Cancer Centre | Glen Goss | Canada | Ottawa | Ottawa |
| Kingston General Hospital | Richard Gregg | Canada | ON | Kingston |
| Royal Victoria Hospital | Vera Hirsh | Canada | QC | Montreal |
| British Columbia Cancer Agency (BCCA) | Christopher Lee | Canada | BC | Surrey |
| British Columbia Cancer Agency (BCCA) | Christopher Lee | Canada | BC | Surrey |
| Montreal General Hospital | Vera Hirsh | Canada | QC | Montreal |
| Odense Universitetshospital | Karin Holmskov Hansen | Denmark | N/A | Odense C |
| Herlev Hospital | Anders Mellemgaard | Denmark | N/A | Herlev |
| Onkologisk afdeling | Kim Wederwang | Denmark | N/A | Nastved |
| Medizinische Universit？tsklinik Freiburg | Cornelius F. Waller | Germany | N/A | Freiburg |
| Universitaetsklinikum Essen | Wilfried Eberhardt | Germany | N/A | Essen |
| Universitaetsklinikum Mannheim | Gerald Schmid-Bindert | Germany | N/A | Mannheim |
| Zentralklinik Bad Berka GmbH | Claus-Peter Schneider | Germany | N/A | Bad Berka |
| Mathias-Spital Rheine | N. Dickgreber | Germany | N/A | Mathias-Spital Rheine |
| Lungenklinik Hemer | Monika Serke | Germany | N/A | Hemer |
| Universitaetsklinikum Hamburg-Eppendorf | Lars Arne Berger | Germany | N/A | Hamburg |
| Klinikum Esslingen GmbH | Martin Faehling | Germany | N/A | Esslingen |
| Universitaetsklinikum Muenster | Rainer Wiewrodt | Germany | N/A | Muenster |
| Johann Wolfgang Goethe Universit？t | Martin Sebastian | Germany | N/A | Frankfurt am Main |
| Hospital Universitari Vall d'Hebron | Enriqueta Felip | Spain | N/A | Barcelona |
| Hospital Clínico Lozano Blesa | Lola Isla | Spain | SPAIN | Zaragoza |
| Hospital Clinico Universitario San Carlos | Jose Luis Gonzalez Larriba | Spain | N/A | Madrid |
| Hospital General Carlos Haya | Manuel Cobo | Spain | N/A | Málaga |
| Hospital Clinico Valencia | Amelia Insa | Spain | N/A | Valencia |
| Hospital Universitario La Paz | Javier De Castro | Spain | N/A | Madrid |
| Hospital Virgen de la Victoria | Jose Manuel Trigo | Spain | N/A | Malaga |
| Hospital Santa Creu i Sant Pau | Margarida Majem | Spain | N/A | Barcelona |
| Complejo Hospitalario Universitario Juan Canalejo | Rosario García Campelo | Spain | N/A | A Coruna |
| CHU de Caen | Jeannick Madelaine | France | N/A | Caen |
| Institut Gustave Roussy | Jean-Charles Soria | France | N/A | Villejuif |
| Hospital Nord | Fabrice Barlesi | France | N/A | Marseille Cedex 20 |
| Centre Oscar Lambret | Eric Dansin | France | N/A | Lille |
| Hospital Val de Grace | Sylvestre Le Moulec | France | N/A | Paris |
| CH de Créteil | Isabelle Monnet | France | N/A | Creteil |
| CHU de Mulhouse | Didier Debieuvre | France | N/A | Mulhouse |
| Hospital Cochin | Pascaline Boudou-Rouquette | France | F | Paris |
| Institut Paoli Calmettes | Anne Madroszyk | France | N/A | Marseille |
| Hospital Calmette - CHRU de Lille | Arnaud Scherpereel | France | N/A | Lille |
| CH le Mans | Olivier Molinier | France | N/A | Le Mans |
| Institut Jean Godinot | Alain Prevost | France | N/A | Reims |
| CHU de Rennes | Hervé Lena | France | N/A | Rennes |
| Institut Bergonié | Francois Chomy | France | N/A | Bordeaux |
| Centre Hospitalier de Chauny | Patrick Dumont | France | N/A | Chauny |
| CHU Gabriel Montpied | Patrick Merle | France | F | Clermont Ferrand |
| Centre Hospitalier de Chauny | Patrick Dumont | France | N/A | Chauny |
| CHU Gabriel Montpied | Patrick Merle | France | F | Clermont Ferrand |
| Hospital Foch | Sylvie Friard | France | N/A | Suresnes |
| Centre Hospitalier | Charles Dayen | France | N/A | Saint Quentin |
| Nouvel Hospital Civil | Elisabeth Quoix | France | N/A | Strasbourg |
| CHU d'Angers | Nathalie Baize | France | N/A | Angers Cedex 9 |
| University Hospital of Heraklion | Dimitrios Mavroudis | Greece | N/A | Heraklio |
| General Hospital of Thessaloniki | Georgios Fountzilas | Greece | N/A | Thessaloniki |
| ''Hippokratio'' Hospital of Athens | Dimitrios Pectasides | Greece | N/A | Athens |
| General Hospitla of Larisa | Athanasios Athanasiadis | Greece | N/A | Larisa |
| University Hospital of Larisa, Oncology Clinic | Christos Papandreou | Greece | N/A | Larisa |
| Metropolitan Hospital, Oncology Clinic | Dimosthenis Skarlos | Greece | N/A | Neo Faliro, Athens |
| General Hospital of Chest Diseases Sotiria | Konstantinos Syrigos | Greece | N/A | Athens |
| V S Hospital | S. Subramanian | India | TAMIL NADU | Chennai |
| Sri Ramachandra Medical Center | Anita Ramesh | India | TAMIL NADU | Chennai |
| M S Patel Cancer Center | Chiramana Haritha | India | GUJARAT | Karamsad |
| Medical Oncology | Chanchal Goswami | India | WEST BENGA | Kolkata |
| Vikram Hospital | Niti Raizada Narang | India | N/A | Bangalore |
| G Kuppuswami Memorial Hospital | Sivanesan Balasubramanian | India | TAMIL NADU | Coimbatore |
| Dr. Kamakshi Memorial Hospital | Srinivasan Venkatesan | India | N/A | Chennai |
| Tata Memorial Hospital | Kumar Prabhash | India | N/A | Mumbai |
| KEM Hospital/Ruby Hall Clinic, Pune | Minish Jain | India | N/A | Pune |
| A. O. Universitaria di Parma | Marcello Tiseo | Italy | IT | Parma |
| P.O. Bellaria - Maggiore | Alba Brandes | Italy | IT | Bologna |
| A.O. Citta' della Salute e della Scienza di Torino | Libero Ciuffreda | Italy | IT | Torino |
| AOU Pisana | Enrico Vasile | Italy | IT | Pisa |
| Adolfo Favaretto | Adolfo Favaretto | Italy | IT | Adolfo Favaretto |
| Ospedale | Francesco FERRAU' | Italy | IT | Taormina |
| Istituti Nazionale Tumori | Alessandro Morabito | Italy | IT | Napoli |
| AO Istituti Ospedalieri di Cremona | Rodolfo Passalacqua | Italy | IT | Cremona |
| Istituto Clinico Humanitas IRCCS | Armando Santoro | Italy | N/A | Rozzano (MI) |
| AOU Santa Maria della Misericordia | Simona Rizzato | Italy | IT | Udine |
| Spedali Riuniti di Livorno | Federico Cappuzzo | Italy | IT | LIVORNO |
| Amphia Ziekenhuis | J.G.J.V. Aerts | Netherlands | N/A | BREDA |
| Jeroen Bosch Ziekenhuis | B. Biesma | Netherlands | N/A | DEN BOSCH |
| Catharina Ziekenhuis | B.E.E.M. Borne van den | Netherlands | N/A | EINDHOVEN |
| Maastricht Universitair Medisch Centrum | A.M.C. Dingemans | Netherlands | N/A | MAASTRICHT |
| Sint Antonius Ziekenhuis | G.J.M. Herder | Netherlands | N/A | NIEUWEGEIN |
| Erasmus Medisch Centrum | R. Peric | Netherlands | N/A | ROTTERDAM |
| Rijnstate, locatie Arnhem | J.M. Smit | Netherlands | N/A | ARNHEM |
| Centro Hospitalar Lisboa Norte | Encarnacao Teixeira | Portugal | N/A | Lisboa |
| Instituto Português de Oncologia do Porto Francisco Gentil | Isabel Azevedo | Portugal | N/A | Porto |
| Instituto Portugues de Oncologia Lisboa Francisco Gentil | Teresa Almodovar | Portugal | N/A | Lisboa |
| Centro Hospitalar de Vila Nova de Gaia/Espinho | Bárbara Parente | Portugal | N/A | Vila Nova de Gaia |
| Centro Hospitalar S？o Jo？o, EPE | Henrique Queiroga | Portugal | N/A | Porto |
| Centro Hospitalar e Universitário de Coimbra, EPE | Fernando Barata | Portugal | N/A | Coimbra |
| Centro Oncológico de Rosario | Luis Fein | Argentina | STA FE | Rosario |
| Instituto Medico Especializado Alexander Fleming | Claudio Martin | Argentina | BS AS | Ciudad Autonoma de Buenos Aires |
| Clínica Colombo | Norma Pilnik | Argentina | N/A | Córdoba |
| Direccion Av. Sarmiento 157 | Felipe Salvador Palazzo | Argentina | TUCUMAN | San Miguel de Tucuman |
| Instituto Oncologico de Cordoba | Eduardo Richardet | Argentina | CORDOBA | Cordoba |
| Instituto Nacional de Cancerologia | Oscar Gerardo Arrieta Rodriguez | Mexico | DF | Mexico |
| Centro Hemato Oncológico Privado | ángel Gomez Villanueva | Mexico | MEXICO | Toluca |
| OCA Hospital | Francisco Alejo Medina Soto | Mexico | NUEVO LEON | Monterrey |
| Centro Internacional de Estudios Clínicos - CIEC | Osvaldo Aren | Chile | N/A | Santiago |
| Instituto de Terapias Oncológicas Providencia | Christian Lorenzo Caglevic Medina | Chile | N/A | Providencia |
| Orlandi Oncologia | Francisco Javier Orlandi Jorquera | Chile | SANTIAGO | Vitacura |
| Centro Oncológico Antofagasta | Luis Alejandro Matamala Rebolledo | Chile | REGION II | Antofagasta |
| National Taiwan University Hospital | Chin Hsin Yang | 中国 | N/A | Taipei |
| Taipei Veterans General Hospital, | Chun-Ming Tsai | 中国 | N/A | Taipei |
| Chang Gung Memorial Hospital,Linkou | Cheng-Ta Yang | 中国 | N/A | Taoyuan |
| Taichung Veterans General Hospital | Gee-Chen Chang | 中国 | N/A | Taichung |
| China Medical University Hospital | Te-Chun Hsia | 中国 | N/A | Taichung |
| Buddhist Tzu Chi General Hospital | Chun-Liang Lai | 中国 | N/A | Chiayi |
| Kaohsiung Chang Gung Memorial Hospital | Chin-Chou Wang | 中国 | N/A | Kaohsiung |
| Koo Foundation Sun Yet-Sen Cancer Center | Lun-Wei Chiou | 中国 | N/A | Taipei |
| Chang Gung Memorial Hospital Chiayi | Ying-Huang Tsai | 中国 | N/A | Chiayi |
| Chungbuk National University Hospital | Ki Hyeong Lee | Korea, Republic of | N/A | Cheongju |
| Gachon University Gil Medical Center | Eun Kyung Cho | Korea, Republic of | N/A | Incheon |
| The Catholic University of Korea, Seoul St.Mary's Hospital | Jin-Hyoung Kang | Korea, Republic of | NA | Seoul |
| Seoul National University Bundang Seoul National University Bundang HospitalHospital | Jong-Seok Lee | Korea, Republic of | NA | Seongnam |
| Samsung Medical Center | Keunchil Park | Korea, Republic of | NA | Seoul |
| Asan Medical Center | Sang-We Kim | Korea, Republic of | N/A | Seoul |
| Ulsan University Hospital | Young Joo Min | Korea, Republic of | NA | Ulsan |
| The Catholic University of Korea, St.Vincent's Hospital | HoonKyo Kim | Korea, Republic of | NA | Suwon |
| Gyeongsang National University Hospital | Hoon-Gu Kim | Korea, Republic of | NA | Jinju |
| SMZ Baumgartner H？he - Otto Wagner Spital Wien | Andrea Mohn-Staudner | Austria | N/A | Wien |
| Universitatsklinik Innsbruck | Wolfgang Eisterer | Austria | N/A | Innsbruck |
| SMZ Baumgartner H？he - Otto Wagner Spital Wien | Otto Burghuber | Austria | N/A | Wien |
| Landeskrankenhaus Leoben | Martin Flicker | Austria | A | Leoben |
| Allgemeines Krankenhaus Linz | Roland Kropfmüller | Austria | N/A | Linz |
| Koranyi National Institute for TBC and Pulmonology | Andrea Fulop | Hungary | N/A | Budapest |
| Koranyi National Institute for TBC and Pulmonology | Gyula Ostoros | Hungary | N/A | Budapest |
| Koranyi National Institute for TBC and Pulmonology | Krisztina Bogos | Hungary | N/A | Budapest |
| Pest County Lung Hospital | Zsuzsanna Mark | Hungary | N/A | Torokbalint |
| Semmelweis University | Gyorgy Losonczy | Hungary | N/A | Budapest |
| Institute of Chest Diseases of Csongrad County Municipality | Attila Somfay | Hungary | N/A | Deszk |
| Josa Andras Hospital | Peter Szabo | Hungary | N/A | Nyiregyhaza |
| University of Pecs | Veronika Sarosi | Hungary | N/A | Pecs |
| Veszprem County Lung Hospital | Zsolt Kiraly | Hungary | N/A | Farkasgyepü |
| Aladar Petz County Teaching Hospital | Gabriella Herodek | Hungary | N/A | Gyor |
| Lung Hospital of Matra | Istvan Albert | Hungary | N/A | Matrahaza |
| National Cancer Centre | Eng Huat Tan | Singapore | N/A | Singapore |
| John Hopkins Singapore International Medical Centre | Yee Hong Chia | Singapore | N/A | Singapore |
| Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali | Erdem Goker | Turkey | N/A | Izmir |
| Dicle Universitesi Tip Fakultesi | Abdurrahman Isikdogan | Turkey | N/A | Diyarbakir |
| Gaziantep Univ. Tip Fakultesi Tibbi Onkoloji Bilim Dali | Alper Sevinc | Turkey | N/A | Gaziantep |
| Akdeniz Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali | Hasan Senol Coskun | Turkey | N/A | Antalya |
| Uludag Universitesi Tip Fakultesi Ic Hastaliklari A.B.D | Turkkan Evrensel | Turkey | N/A | Bursa |
| Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Ara | Murat Kiyik | Turkey | N/A | Istanbul |
| Dr. Lütfi Kirdar Egitim ve Arastirma Hastanesi | Mehmet Aliustaoglu | Turkey | N/A | Istanbul |
| Dr. Suat Seren Gogus Hastaliklari ve Gogus Cerrahisi Hast. | Salih Zeki Guclu | Turkey | N/A | Izmir |
| The Royal Marsden NHS Foundation Trust | Sanjaykumar Popat | Great Britain | N/A | London |
| The Royal Marsden NHS Foundation Trust | Sanjaykumar Popat | Great Britain | SURREY | Sutton |
| Royal Devon & Exeter NHS Foundation Trust | Elizabeth Toy | Great Britain | DEVON | Exeter |
| Royal Free Hampstead NHS Trust | Ekaterini Boleti | Great Britain | N/A | London |
| Maidstone and Tunbridge Wells NHS Trust | Riyaz Shah | Great Britain | N/A | Maidstone |
| University Hospitals Birmingham NHS Foundation Trust | Ian Woolhouse | Great Britain | N/A | Birmingham |
| Nottingham University Hospitals NHS Trust | Vanessa Potter | Great Britain | N/A | Nottingham |
| NHS Greater Glasgow and Clyde | Nicola Steele | Great Britain | SCOTLAND | Glasgow |
| Scarborough and North East Yorkshire Hospitals | Rachael Barton | Great Britain | N/A | Scarborough |
| Harrogate and District NHS Foundation Trust | Samuel Chan | Great Britain | N/A | Harrogate |
| St James Hospital | Sinead Cuffe | Ireland | N/A | Dublin 8 |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 上海市胸科医院伦理委员会 | 同意 | 2012-06-05 |
试验状态信息
试验状态
已完成
目标入组人数
国内: 65 人；
国际: 800 人；
已入组例数
国内: 登记人暂未填写该信息；
国际: 登记人暂未填写该信息；
实际入组总例数
国内: 67 人 ；
国际: 795 人；
第一例受试者签署知情同意书日期
国内：登记人暂未填写该信息；
国际：登记人暂未填写该信息；
第一例受试者入组日期
国内：2012-07-09；
国际：2012-03-29；
试验终止日期
国内：2018-02-20；
国际：2018-02-20；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
