阿法替尼与厄洛替尼比较作为治疗肺鳞癌的临床试验

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试验详情

一、临床试验项目名称
阿法替尼与厄洛替尼比较作为治疗肺鳞癌的临床试验

二、适应症
非小细胞肺癌

三、试验介绍

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。

研究中心所在省份及城市（具体启动情况以后期咨询为准）

研究中心	主要研究者
上海市胸科医院	陆舜

序号	机构名称	主要研究者	国家	省（州）	城市
1	上海市胸科医院	陆舜	中国	上海	上海
2	南京八一医院	秦叔逵	中国	江苏	南京
3	北京医院	程刚	中国	北京	北京
4	吉林大学附属第一医院	李薇	中国	吉林	长春
5	中山大学肿瘤防治中心	张力	中国	广东	广州
6	中南大学湘雅医院	胡成平	中国	湖南	长沙
7	北京肿瘤医院	王洁	中国	北京	北京
8	上海肺科医院	周彩存	中国	上海	上海
9	江苏省肿瘤医院	冯继锋	中国	江苏	南京
10	Cancer Care of North Florida, PA	Waseemullah Khan	United States of America	FL	Lake City
11	North Shore Hematology Oncology	Ira Oliff	United States of America	IL	Skokie
12	St. Joseph's Mercy Clinic, Inc	Manjusha Kota	United States of America	AZ	Hot Springs
13	Queens Medical Associates	Barry Kaplan	United States of America	NY	Fresh Meadows
14	Spartanburg Regional Medical Center	Charles Bowers	United States of America	SC	Spartanburg
15	Sutter Medical Group	Deepti Behl	United States of America	CA	Sacramento
16	Cancer Therapy & Research @ UTHSCSA	Athanassios Argiris	United States of America	TX	San Antonio
17	Cleveland Clinic	Nathan Pennell	United States of America	OH	Cleveland
18	Karmanos Cancer Institute	Shirish Gadgeel	United States of America	MI	Detroit
19	University of Louisville-James Graham Brown Cancer Center	Goetz Kloecker	United States of America	KY	Louisville
20	Kaiser Permanente Northwest Region	Mark Rarick	United States of America	OR	Portland
21	Moores UC San Diego Cancer Center	Lyudmila Bazhenova	United States of America	CA	La Jolla
22	Lahey Clinic	Paul Hesketh	United States of America	MA	Burlington
23	Ohio State University	Gregory Otterson	United States of America	OH	Columbus
24	Blue Ridge Cancer Care	Jerome Goldschmidt	United States of America	VA	Christianburg
25	Cancer Center of Acadiana	Salman Malad	United States of America	IN	Lafayette
26	Paris Cancer Center (PCC) Texas Oncology	Sucharu Prakash	United States of America	TX	Paris
27	Washington University	Maria Baggstrom	United States of America	MO	St. Louis
28	Fletcher Allen Health Care Inc.	Farrah Khan	United States of America	VT	Burlington
29	SUNY Upstate Medical University	Stephen Graziano	United States of America	NY	Syracuse
30	Oncology Hematology Associates of Northern Pennsylvania, PC	Carmine Marchioli	United States of America	PA	DuBois
31	Illinois Cancer Specialists	Leonard Klein	United States of America	IL	Niles
32	Memorial Healthcare System	Luis Raez	United States of America	FL	Hollywood
33	Boca Raton Regional Hospital-Lynn Cancer Institute	Edgardo Santos	United States of America	FL	Boca Raton
34	Cancer Center of Cookeville Regional Medical Center	Paul Jacquin	United States of America	TN	Cookeville
35	Montefiore Medical Center	Bilal Piperdi	United States of America	NY	Bronx
36	Mid Ohio Oncology/Hematology, Inc	Taral Patel	United States of America	OH	Columbus
37	Commonwealth Hematology-Oncology, PC	Pedro Sanz-Altamira	United States of America	MA	Lawrence
38	Ironwood Cancer & Research Centers	Sujith Kalmadi	United States of America	AZ	Chandler
39	Virginia Oncology Associates	John Paschold	United States of America	VA	Norfolk
40	Billings Clinic Cancer Center	Jorge Nieva	United States of America	MT	Billings
41	Temple University Cancer Center	Deric Savior	United States of America	PA	Philadelphia
42	Thomas Jefferson University	Rita Axelrod	United States of America	PA	Philadelphia
43	West Jefferson General Hospital and Cancer Clinic	Nagarajan Chandrasekaran	United States of America	LA	Marrero
44	Montifiore Medical Center	Bilal Piperdi	United States of America	NY	Bronx
45	Ottawa Hospital Regional Cancer Centre	Glen Goss	Canada	Ottawa	Ottawa
46	Kingston General Hospital	Richard Gregg	Canada	ON	Kingston
47	Royal Victoria Hospital	Vera Hirsh	Canada	QC	Montreal
48	British Columbia Cancer Agency (BCCA)	Christopher Lee	Canada	BC	Surrey
49	British Columbia Cancer Agency (BCCA)	Christopher Lee	Canada	BC	Surrey
50	Montreal General Hospital	Vera Hirsh	Canada	QC	Montreal
51	Odense Universitetshospital	Karin Holmskov Hansen	Denmark	N/A	Odense C
52	Herlev Hospital	Anders Mellemgaard	Denmark	N/A	Herlev
53	Onkologisk afdeling	Kim Wederwang	Denmark	N/A	Nastved
54	Medizinische Universit？tsklinik Freiburg	Cornelius F. Waller	Germany	N/A	Freiburg
55	Universitaetsklinikum Essen	Wilfried Eberhardt	Germany	N/A	Essen
56	Universitaetsklinikum Mannheim	Gerald Schmid-Bindert	Germany	N/A	Mannheim
57	Zentralklinik Bad Berka GmbH	Claus-Peter Schneider	Germany	N/A	Bad Berka
58	Mathias-Spital Rheine	N. Dickgreber	Germany	N/A	Mathias-Spital Rheine
59	Lungenklinik Hemer	Monika Serke	Germany	N/A	Hemer
60	Universitaetsklinikum Hamburg-Eppendorf	Lars Arne Berger	Germany	N/A	Hamburg
61	Klinikum Esslingen GmbH	Martin Faehling	Germany	N/A	Esslingen
62	Universitaetsklinikum Muenster	Rainer Wiewrodt	Germany	N/A	Muenster
63	Johann Wolfgang Goethe Universit？t	Martin Sebastian	Germany	N/A	Frankfurt am Main
64	Hospital Universitari Vall d'Hebron	Enriqueta Felip	Spain	N/A	Barcelona
65	Hospital Clínico Lozano Blesa	Lola Isla	Spain	SPAIN	Zaragoza
66	Hospital Clinico Universitario San Carlos	Jose Luis Gonzalez Larriba	Spain	N/A	Madrid
67	Hospital General Carlos Haya	Manuel Cobo	Spain	N/A	Málaga
68	Hospital Clinico Valencia	Amelia Insa	Spain	N/A	Valencia
69	Hospital Universitario La Paz	Javier De Castro	Spain	N/A	Madrid
70	Hospital Virgen de la Victoria	Jose Manuel Trigo	Spain	N/A	Malaga
71	Hospital Santa Creu i Sant Pau	Margarida Majem	Spain	N/A	Barcelona
72	Complejo Hospitalario Universitario Juan Canalejo	Rosario García Campelo	Spain	N/A	A Coruna
73	CHU de Caen	Jeannick Madelaine	France	N/A	Caen
74	Institut Gustave Roussy	Jean-Charles Soria	France	N/A	Villejuif
75	Hospital Nord	Fabrice Barlesi	France	N/A	Marseille Cedex 20
76	Centre Oscar Lambret	Eric Dansin	France	N/A	Lille
77	Hospital Val de Grace	Sylvestre Le Moulec	France	N/A	Paris
78	CH de Créteil	Isabelle Monnet	France	N/A	Creteil
79	CHU de Mulhouse	Didier Debieuvre	France	N/A	Mulhouse
80	Hospital Cochin	Pascaline Boudou-Rouquette	France	F	Paris
81	Institut Paoli Calmettes	Anne Madroszyk	France	N/A	Marseille
82	Hospital Calmette - CHRU de Lille	Arnaud Scherpereel	France	N/A	Lille
83	CH le Mans	Olivier Molinier	France	N/A	Le Mans
84	Institut Jean Godinot	Alain Prevost	France	N/A	Reims
85	CHU de Rennes	Hervé Lena	France	N/A	Rennes
86	Institut Bergonié	Francois Chomy	France	N/A	Bordeaux
87	Centre Hospitalier de Chauny	Patrick Dumont	France	N/A	Chauny
88	CHU Gabriel Montpied	Patrick Merle	France	F	Clermont Ferrand
89	Centre Hospitalier de Chauny	Patrick Dumont	France	N/A	Chauny
90	CHU Gabriel Montpied	Patrick Merle	France	F	Clermont Ferrand
91	Hospital Foch	Sylvie Friard	France	N/A	Suresnes
92	Centre Hospitalier	Charles Dayen	France	N/A	Saint Quentin
93	Nouvel Hospital Civil	Elisabeth Quoix	France	N/A	Strasbourg
94	CHU d'Angers	Nathalie Baize	France	N/A	Angers Cedex 9
95	University Hospital of Heraklion	Dimitrios Mavroudis	Greece	N/A	Heraklio
96	General Hospital of Thessaloniki	Georgios Fountzilas	Greece	N/A	Thessaloniki
97	''Hippokratio'' Hospital of Athens	Dimitrios Pectasides	Greece	N/A	Athens
98	General Hospitla of Larisa	Athanasios Athanasiadis	Greece	N/A	Larisa
99	University Hospital of Larisa, Oncology Clinic	Christos Papandreou	Greece	N/A	Larisa
100	Metropolitan Hospital, Oncology Clinic	Dimosthenis Skarlos	Greece	N/A	Neo Faliro, Athens
101	General Hospital of Chest Diseases Sotiria	Konstantinos Syrigos	Greece	N/A	Athens
102	V S Hospital	S. Subramanian	India	TAMIL NADU	Chennai
103	Sri Ramachandra Medical Center	Anita Ramesh	India	TAMIL NADU	Chennai
104	M S Patel Cancer Center	Chiramana Haritha	India	GUJARAT	Karamsad
105	Medical Oncology	Chanchal Goswami	India	WEST BENGA	Kolkata
106	Vikram Hospital	Niti Raizada Narang	India	N/A	Bangalore
107	G Kuppuswami Memorial Hospital	Sivanesan Balasubramanian	India	TAMIL NADU	Coimbatore
108	Dr. Kamakshi Memorial Hospital	Srinivasan Venkatesan	India	N/A	Chennai
109	Tata Memorial Hospital	Kumar Prabhash	India	N/A	Mumbai
110	KEM Hospital/Ruby Hall Clinic, Pune	Minish Jain	India	N/A	Pune
111	A. O. Universitaria di Parma	Marcello Tiseo	Italy	IT	Parma
112	P.O. Bellaria - Maggiore	Alba Brandes	Italy	IT	Bologna
113	A.O. Citta' della Salute e della Scienza di Torino	Libero Ciuffreda	Italy	IT	Torino
114	AOU Pisana	Enrico Vasile	Italy	IT	Pisa
115	Adolfo Favaretto	Adolfo Favaretto	Italy	IT	Adolfo Favaretto
116	Ospedale	Francesco FERRAU'	Italy	IT	Taormina
117	Istituti Nazionale Tumori	Alessandro Morabito	Italy	IT	Napoli
118	AO Istituti Ospedalieri di Cremona	Rodolfo Passalacqua	Italy	IT	Cremona
119	Istituto Clinico Humanitas IRCCS	Armando Santoro	Italy	N/A	Rozzano (MI)
120	AOU Santa Maria della Misericordia	Simona Rizzato	Italy	IT	Udine
121	Spedali Riuniti di Livorno	Federico Cappuzzo	Italy	IT	LIVORNO
122	Amphia Ziekenhuis	J.G.J.V. Aerts	Netherlands	N/A	BREDA
123	Jeroen Bosch Ziekenhuis	B. Biesma	Netherlands	N/A	DEN BOSCH
124	Catharina Ziekenhuis	B.E.E.M. Borne van den	Netherlands	N/A	EINDHOVEN
125	Maastricht Universitair Medisch Centrum	A.M.C. Dingemans	Netherlands	N/A	MAASTRICHT
126	Sint Antonius Ziekenhuis	G.J.M. Herder	Netherlands	N/A	NIEUWEGEIN
127	Erasmus Medisch Centrum	R. Peric	Netherlands	N/A	ROTTERDAM
128	Rijnstate, locatie Arnhem	J.M. Smit	Netherlands	N/A	ARNHEM
129	Centro Hospitalar Lisboa Norte	Encarnacao Teixeira	Portugal	N/A	Lisboa
130	Instituto Português de Oncologia do Porto Francisco Gentil	Isabel Azevedo	Portugal	N/A	Porto
131	Instituto Portugues de Oncologia Lisboa Francisco Gentil	Teresa Almodovar	Portugal	N/A	Lisboa
132	Centro Hospitalar de Vila Nova de Gaia/Espinho	Bárbara Parente	Portugal	N/A	Vila Nova de Gaia
133	Centro Hospitalar S？o Jo？o, EPE	Henrique Queiroga	Portugal	N/A	Porto
134	Centro Hospitalar e Universitário de Coimbra, EPE	Fernando Barata	Portugal	N/A	Coimbra
135	Centro Oncológico de Rosario	Luis Fein	Argentina	STA FE	Rosario
136	Instituto Medico Especializado Alexander Fleming	Claudio Martin	Argentina	BS AS	Ciudad Autonoma de Buenos Aires
137	Clínica Colombo	Norma Pilnik	Argentina	N/A	Córdoba
138	Direccion Av. Sarmiento 157	Felipe Salvador Palazzo	Argentina	TUCUMAN	San Miguel de Tucuman
139	Instituto Oncologico de Cordoba	Eduardo Richardet	Argentina	CORDOBA	Cordoba
140	Instituto Nacional de Cancerologia	Oscar Gerardo Arrieta Rodriguez	Mexico	DF	Mexico
141	Centro Hemato Oncológico Privado	ángel Gomez Villanueva	Mexico	MEXICO	Toluca
142	OCA Hospital	Francisco Alejo Medina Soto	Mexico	NUEVO LEON	Monterrey
143	Centro Internacional de Estudios Clínicos - CIEC	Osvaldo Aren	Chile	N/A	Santiago
144	Instituto de Terapias Oncológicas Providencia	Christian Lorenzo Caglevic Medina	Chile	N/A	Providencia
145	Orlandi Oncologia	Francisco Javier Orlandi Jorquera	Chile	SANTIAGO	Vitacura
146	Centro Oncológico Antofagasta	Luis Alejandro Matamala Rebolledo	Chile	REGION II	Antofagasta
147	National Taiwan University Hospital	Chin Hsin Yang	中国	N/A	Taipei
148	Taipei Veterans General Hospital,	Chun-Ming Tsai	中国	N/A	Taipei
149	Chang Gung Memorial Hospital,Linkou	Cheng-Ta Yang	中国	N/A	Taoyuan
150	Taichung Veterans General Hospital	Gee-Chen Chang	中国	N/A	Taichung
151	China Medical University Hospital	Te-Chun Hsia	中国	N/A	Taichung
152	Buddhist Tzu Chi General Hospital	Chun-Liang Lai	中国	N/A	Chiayi
153	Kaohsiung Chang Gung Memorial Hospital	Chin-Chou Wang	中国	N/A	Kaohsiung
154	Koo Foundation Sun Yet-Sen Cancer Center	Lun-Wei Chiou	中国	N/A	Taipei
155	Chang Gung Memorial Hospital Chiayi	Ying-Huang Tsai	中国	N/A	Chiayi
156	Chungbuk National University Hospital	Ki Hyeong Lee	Korea, Republic of	N/A	Cheongju
157	Gachon University Gil Medical Center	Eun Kyung Cho	Korea, Republic of	N/A	Incheon
158	The Catholic University of Korea, Seoul St.Mary's Hospital	Jin-Hyoung Kang	Korea, Republic of	NA	Seoul
159	Seoul National University Bundang Seoul National University Bundang HospitalHospital	Jong-Seok Lee	Korea, Republic of	NA	Seongnam
160	Samsung Medical Center	Keunchil Park	Korea, Republic of	NA	Seoul
161	Asan Medical Center	Sang-We Kim	Korea, Republic of	N/A	Seoul
162	Ulsan University Hospital	Young Joo Min	Korea, Republic of	NA	Ulsan
163	The Catholic University of Korea, St.Vincent's Hospital	HoonKyo Kim	Korea, Republic of	NA	Suwon
164	Gyeongsang National University Hospital	Hoon-Gu Kim	Korea, Republic of	NA	Jinju
165	SMZ Baumgartner H？he - Otto Wagner Spital Wien	Andrea Mohn-Staudner	Austria	N/A	Wien
166	Universitatsklinik Innsbruck	Wolfgang Eisterer	Austria	N/A	Innsbruck
167	SMZ Baumgartner H？he - Otto Wagner Spital Wien	Otto Burghuber	Austria	N/A	Wien
168	Landeskrankenhaus Leoben	Martin Flicker	Austria	A	Leoben
169	Allgemeines Krankenhaus Linz	Roland Kropfmüller	Austria	N/A	Linz
170	Koranyi National Institute for TBC and Pulmonology	Andrea Fulop	Hungary	N/A	Budapest
171	Koranyi National Institute for TBC and Pulmonology	Gyula Ostoros	Hungary	N/A	Budapest
172	Koranyi National Institute for TBC and Pulmonology	Krisztina Bogos	Hungary	N/A	Budapest
173	Pest County Lung Hospital	Zsuzsanna Mark	Hungary	N/A	Torokbalint
174	Semmelweis University	Gyorgy Losonczy	Hungary	N/A	Budapest
175	Institute of Chest Diseases of Csongrad County Municipality	Attila Somfay	Hungary	N/A	Deszk
176	Josa Andras Hospital	Peter Szabo	Hungary	N/A	Nyiregyhaza
177	University of Pecs	Veronika Sarosi	Hungary	N/A	Pecs
178	Veszprem County Lung Hospital	Zsolt Kiraly	Hungary	N/A	Farkasgyepü
179	Aladar Petz County Teaching Hospital	Gabriella Herodek	Hungary	N/A	Gyor
180	Lung Hospital of Matra	Istvan Albert	Hungary	N/A	Matrahaza
181	National Cancer Centre	Eng Huat Tan	Singapore	N/A	Singapore
182	John Hopkins Singapore International Medical Centre	Yee Hong Chia	Singapore	N/A	Singapore
183	Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali	Erdem Goker	Turkey	N/A	Izmir
184	Dicle Universitesi Tip Fakultesi	Abdurrahman Isikdogan	Turkey	N/A	Diyarbakir
185	Gaziantep Univ. Tip Fakultesi Tibbi Onkoloji Bilim Dali	Alper Sevinc	Turkey	N/A	Gaziantep
186	Akdeniz Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali	Hasan Senol Coskun	Turkey	N/A	Antalya
187	Uludag Universitesi Tip Fakultesi Ic Hastaliklari A.B.D	Turkkan Evrensel	Turkey	N/A	Bursa
188	Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Ara	Murat Kiyik	Turkey	N/A	Istanbul
189	Dr. Lütfi Kirdar Egitim ve Arastirma Hastanesi	Mehmet Aliustaoglu	Turkey	N/A	Istanbul
190	Dr. Suat Seren Gogus Hastaliklari ve Gogus Cerrahisi Hast.	Salih Zeki Guclu	Turkey	N/A	Izmir
191	The Royal Marsden NHS Foundation Trust	Sanjaykumar Popat	Great Britain	N/A	London
192	The Royal Marsden NHS Foundation Trust	Sanjaykumar Popat	Great Britain	SURREY	Sutton
193	Royal Devon & Exeter NHS Foundation Trust	Elizabeth Toy	Great Britain	DEVON	Exeter
194	Royal Free Hampstead NHS Trust	Ekaterini Boleti	Great Britain	N/A	London
195	Maidstone and Tunbridge Wells NHS Trust	Riyaz Shah	Great Britain	N/A	Maidstone
196	University Hospitals Birmingham NHS Foundation Trust	Ian Woolhouse	Great Britain	N/A	Birmingham
197	Nottingham University Hospitals NHS Trust	Vanessa Potter	Great Britain	N/A	Nottingham
198	NHS Greater Glasgow and Clyde	Nicola Steele	Great Britain	SCOTLAND	Glasgow
199	Scarborough and North East Yorkshire Hospitals	Rachael Barton	Great Britain	N/A	Scarborough
200	Harrogate and District NHS Foundation Trust	Samuel Chan	Great Britain	N/A	Harrogate
201	St James Hospital	Sinead Cuffe	Ireland	N/A	Dublin 8

1	鳞状组织学晚期NSCLC诊断。
2	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。
3	研究者认为适合接受二线治疗。
4	根据RECIST1.1有可测量病灶。
5	适当的体力状态。
6	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。
7	适当的器官功能。
8	年龄≥ 18 岁。
9	签署了符合 ICH - GCP 指导原则的书面知情同意书。

1	先前接受表皮生长因子受体靶向的小分子或抗体的治疗。
2	随机化前 4 周内放疗。
3	活动性的脑转移。
4	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）。
5	已知的预先存在的间质性肺病。
6	重大或近期的以腹泻为主要症状的急性胃肠疾病。
7	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。
8	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。
9	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。
10	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
11	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。
12	对阿法替尼或厄洛替尼的治疗有任何禁忌。
13	已知对厄洛替尼、阿法替尼或试验药物的任何辅药过敏。
14	开始研究治疗前4 周内大手术。
15	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。
16	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
17	患者没有出现疾病进展。

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