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Brief Title: BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
Official Title: A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
Study ID: NCT00949650
Brief Summary: This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Highlands Oncology Group, Fayetteville, Arkansas, United States
Clinical Trials and Research Associates Inc, Montebello, California, United States
Innovative Medical Research of South Florida, Miami, Florida, United States
Crescent City Research Consortiom, Marrero, Louisiana, United States
Interlakes Foundation, Incorporated, Rochester, New York, United States
Lehigh Valley Hospital / Lehigh Valley Health Network, Allentown, Pennsylvania, United States
South Texas Institute of Cancer, Northwest Cancer Center, Corpus Christi, Texas, United States
Instituto de Medicina Nuclear de Bahía Blanca, Bahía Blanca, , Argentina
Hospital Alemán, Capital Federal, , Argentina
Imcaba S.R.L., Capital Federal, , Argentina
IMAI Research, Capital Federal, , Argentina
Instituto Alexander Fleming, Capital Federal, , Argentina
Hospital Militar Central, Capital Federal, , Argentina
PALIAR, Capital Federal, , Argentina
Centro Oncológico de Rosario, Rosario, , Argentina
Lifehouse, Camperdown, New South Wales, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Calvary Mater Newcastle Hospital, Waratah, New South Wales, Australia
The Prince Charles Hospital, Chermside, Queensland, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
The Burnside War Memorial Hospital, Toorak Gardens, South Australia, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
St. Vincents Hospital (MEL), Fitzroy, Victoria, Australia
Mount Medical Centre, Perth, Western Australia, Australia
KH d. Elisabethinen Linz, Linz, , Austria
Klinikum Wels - Grieskirchen GmbH, Wels, , Austria
SMZ Baumgartner Hoehe Otto Wagner Spital, Wien, , Austria
Brussels - UNIV St-Pierre, Bruxelles, , Belgium
UNIV UZ Gent, Gent, , Belgium
Brussels - UNIV UZ Brussel, Jette, , Belgium
UZ Leuven, Leuven, , Belgium
Centre Hospitalier Universitaire de Liège, Liège, , Belgium
Centro de Pesquisa do Hospital Lifecenter, Belo Horizonte, , Brazil
Centro de Pesquisas Clínicas em Oncología, Cachoeiro de Itapemirim, , Brazil
Insituto de Oncologia do Paraná, Curitiba, , Brazil
Hospital São Lucas da Pontifícia Universidade Católica, Porto Alegre, , Brazil
UNIFESP Departamento de Medicina de Pneumologia, Sao Paulo, , Brazil
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute (University of Alberta), Edmonton, Alberta, Canada
Charles LeMoyne Hospital, Greenfield Park, Migration Data, Canada
Hematologiste et oncologue medical CHUM - Hopital Notre-Dame, Montreal, Migration Data, Canada
McGill University, Department of Oncology, Montreal, Migration Data, Canada
Hospital Dirección de Previsión de Carabineros, Los Condes, , Chile
Instituto Oncológico Limitada Viña del Mar, Reñaca, , Chile
Instituto Clínico Oncológico del Sur - ICOS, Temuco, , Chile
HOP d'Angers, Angers, , France
HOP Côte de Nacre, Caen Cedex 5, , France
HOP Nord Michallon, La Tronche, , France
HOP Croix Rousse, Pneumo, Lyon, Lyon Cedex 4, , France
INS Curie, Paris Cedex 05, , France
CTR René Gauducheau, Saint Herblain, , France
HOP Sud-Réunion, Pneumo, Saint Pierre, Saint Pierre - La Réunion, , France
HOP - HIA Sainte Anne, Toulon, , France
HOP, Pneumo, Villefranche sur Saône, Villefranche Sur Saône, , France
Universitätsklinikum Benjamin Franklin, Berlin, Berlin, , Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH, Essen, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Lungenklinik Hemer, Hemer, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, , Germany
Universitätsklinikum Münster, Münster, , Germany
Pius-Hospital, Oldenburg, Oldenburg, , Germany
National Taiwan University Hospital, Taipei, , Germany
Queen Mary Hospital, Hong Kong, , Hong Kong
Prince of Wales Hospital, Shatin, , Hong Kong
Szent György Hospital, Szekesfehervar, Szekesfehervar, , Hungary
Markusovszky County Hospital, Szombathely, Szombathely, , Hungary
Zala County Hospital, Zalaegerszeg, Zalaegerszeg, , Hungary
St James's Hospital, Dublin 8, , Ireland
Ospedale San Donato di Arezzo, Arezzo, , Italy
Az. USL 4 di Prato, Prato, , Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza, Roma, , Italy
Osp. Silvestrin, Sant'Andrea Delle Fratte (PG), , Italy
National Hospital Organization Nagoya Medical Center, Aichi, Nagoya, , Japan
Aichi Cancer Center Hospital, Aichi, Nagoya, , Japan
National Cancer Center Hospital East, Chiba, Kashiwa, , Japan
National Hospital Organization Shikoku Cancer Center, Ehime, Matsuyama, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, Fukuoka, , Japan
Hokkaido University Hospital, Hokkaido, Sapporo, , Japan
Institute of Biomedical Research and Innovation Hospital, Hyogo, Kobe, , Japan
Kanazawa University Hospital, Ishikawa, Kanazawa, , Japan
Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Yokohama, , Japan
Niigata Cancer Center Hospital, Niigata, Niigata, , Japan
Kurashiki Central Hospital, Okayama, Kurashiki, , Japan
Okayama University Hospital, Okayama, Okayama, , Japan
Kindai University Hospital, Osaka, Osaka-Sayama, , Japan
Osaka City Hospital Organization Osaka City General Hospital, Osaka, Osaka, , Japan
National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Osaka, , Japan
Shizuoka Cancer Center, Shizuoka, Sunto-gun, , Japan
Chungbuk National University Hospital, Cheongju, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
Hospital Pulau Pinang, Palau Pinang, , Malaysia
Pusat Perubatan University Kebangsaan Malaysia, Wilayah Persekutuan, , Malaysia
University Malaya Medical Centre, Wilayah Persekutuan, , Malaysia
Hospital Nacional Guillermo Almenara Irigoyen, La Victoria, , Peru
Clínica Anglo Americana, San Isidro, , Peru
Instituto Nacional de Enfermedades Neoplásicas, Surquillo, , Peru
Perpetual Succour Hospital (Cebu), Cebu City, , Philippines
Makati Medical Center, Makati City, , Philippines
St. Luke Medical Centre, Quezon, , Philippines
Institutul Oncologic "Prof. Dr. Ion Chiricuta", Cluj Napoca, , Romania
ONCOLAB SRL, Craiova, Craiova, , Romania
Republic Clinical Oncology Dispensary, Dept. Chemotherapy, Kazan, , Russian Federation
FSBSI "N.N Blokhin Medical Research Center of Oncology", Moscow, , Russian Federation
Medical Radiology Science Centre, Obninsk, , Russian Federation
First Pavlov State Medical University Saint Petersburg, St. Petersburg, , Russian Federation
SPb SBIH "City Clinical Oncological Dispensary", St. Petersburg, , Russian Federation
FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF, St. Petersburg, , Russian Federation
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Chang Gung Memorial Hospital Kaohsiung, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
NCKUH, Tainan, , Taiwan
Taipe Veterans General Hospital, Taipei, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital(TaoYuan), Taoyuan, , Taiwan
Ramathibodi Hospital, Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, , Thailand
Srinagarind Hospital, Khonkaen, , Thailand
Songklanagarind Hospital, Songkla, , Thailand
City Clinical Hospital #4, Dnipropetrovsk State Medical Academy, Dnipropetrovsk, , Ukraine
Donetsk Regional Antitumor Centre, Donetsk, , Ukraine
Kharkiv Regional Clinical Oncology Center, Kharkiv, , Ukraine
Lviv State Oncological Regional Treatment & Diagnostic CTR, Lviv, , Ukraine
Royal Devon and Exeter Hospital, Exeter, , United Kingdom
Royal Surrey County Hospital, Guildford, , United Kingdom
The Royal Marsden Hospital, London, , United Kingdom
Maidstone Hospital, Kent Oncology Centre, Maidstone, , United Kingdom
Scunthorpe General Hospital, Oncology, Scunthorpe, , United Kingdom
The Royal Marsden Hospital, Sutton, , United Kingdom
Royal Cornwall Hospital, Truro, , United Kingdom
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR