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Brief Title: LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy
Official Title: LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy
Study ID: NCT01523587
Brief Summary: This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ironwood Cancer and Research Centers, Chandler, Arizona, United States
University of California, La Jolla, California, United States
Sutter Medical Group, Sacramento, California, United States
Boca Raton Reginl Hospital-Lynn Cancer Institute, Boca Raton, Florida, United States
Memorial Healthcare System, Hollywood, Florida, United States
Cancer Care of North Florida, PA, Lake City, Florida, United States
Illinois Cancer Specialists, Niles, Illinois, United States
Orchard Healthcare Research Inc, Skokie, Illinois, United States
University of Louisville, Louisville, Kentucky, United States
West Jefferson General Hospital and Cancer Clinic, Marrero, Louisiana, United States
Lahey Clinic, Burlington, Massachusetts, United States
Commonwealth Hematology-Oncology, PC, Lawrence, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Montefiore Medical Center, Bronx, New York, United States
Montefiore Medical Center, Bronx, New York, United States
Queens Medical Associates, Fresh Meadows, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Mid Ohio Oncology/Hematology, Inc, Columbus, Ohio, United States
Kaiser Permanente Northwest, Portland, Oregon, United States
Oncology Hematology Associates of Norhtern Pennsylvania, PC, DuBois, Pennsylvania, United States
Kimmel Cancer Center, Philadelphia, Pennsylvania, United States
Temple University Cancer Center, Philadelphia, Pennsylvania, United States
Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Cancer Center of Cookeville Regional Medical Center, Cookeville, Tennessee, United States
Paris Cancer Center (PCC), Texas Oncology, Paris, Texas, United States
Cancer Therapy and Research at UTHSCSA, San Antonio, Texas, United States
Fletcher Allen Health Care, Burlington, Vermont, United States
Blue Ridge Cancer Care, Christiansburg, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Instituto Medico Especializado Alexander Fleming, Ciudad Autonoma de Bs As, , Argentina
Instituto Oncologico de Cordoba, Cordoba, , Argentina
Clínica Colombo S.A., Cordoba, , Argentina
Centro Oncologico de Rosario, Rosario, , Argentina
Centro Oncologico CAIPO, San Miguel de Tucuman, , Argentina
Medical University of Innsbruck, Innsbruck, , Austria
LKH Leoben, Leoben, , Austria
AKH d. Stadt Linz, Pulmologie, Linz, , Austria
SMZ Baumgartner Hoehe Otto Wagner Spital, Wien, , Austria
BC Cancer Agency - Fraser Valley Centre, Surrey, British Columbia, Canada
Kingston General Hospital, Kingston, Ontario, Canada
The Ottawa Hospital, Ottawa, Ontario, Canada
Royal Victoria Hospital, Montreal, Quebec, Canada
Montreal General Hospital - McGill University Health Centre, Montreal, Quebec, Canada
Centro Oncologico Antofagasta, Antofagasta, , Chile
Instituto de Terapias Oncologicas Providencia, Providencia, Santiago, , Chile
Centro Internacional de Estudios Clinicos - CIEC, Recoleta, Santiago De Chile, , Chile
Orlandi Oncologia, Vitacura, , Chile
Beijing Cancer Hospital, Beijing, , China
Beijing Hospital, Beijing, , China
First Hospital of Jilin University, Changchun, , China
Xiangya Hospital, Central South University, Changsha, , China
Sun Yat-Sen University Cancer Center, Guangzhou, , China
the 81th Hospital of PLA, Nanjing, , China
Jiangsu Cancer Hospital, Nanjing, , China
Shanghai Chest Hospital, Shanghai, , China
Shanghai Pulmonary Hospital, Shanghai, , China
Herlev Hospital, Herlev, , Denmark
Næstved Sygehus, Næstved, , Denmark
Odense Universitetshospital, Odense C, , Denmark
HOP d'Angers, Angers, , France
INS Bergonié, Bordeaux, , France
HOP Côte de Nacre, Caen, , France
HOP de Chauny, Chauny, , France
HOP Gabriel-Montpied, Clermont Ferrand, , France
HOP de Creteil, Pneumo, Creteil, Creteil, , France
HOP Le Mans, Le Mans, , France
CTR Oscar Lambret, Cancéro, Lille, Lille, , France
HOP Calmette, Lille, , France
HOP Nord, Marseille Cedex 20, , France
INS Paoli-Calmettes, Marseille, , France
HOP de Mulhouse, Onco, Mulhouse, Mulhouse, , France
HOP Cochin, Paris, , France
HOP Val de Grâce, Onco, Paris, Paris, , France
INS Jean Godinot, Onco, Reims, Reims, , France
HOP de Rennes, Pneumo, Rennes, Rennes, , France
HOP Saint Quentin, Onco, Saint Quentin, Saint Quentin, , France
HOP Civil, Strasbourg, , France
HOP Foch, Suresnes, , France
INS Gustave Roussy, Villejuif, , France
Zentralklinik Bad Berka GmbH, Bad Berka, , Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH, Essen, , Germany
Klinikum Esslingen GmbH, Esslingen, , Germany
Universitätsklinikum Frankfurt, Frankfurt am Main, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Lungenklinik Hemer, Hemer, , Germany
Universitätsklinikum Mannheim GmbH, Mannheim, , Germany
Universitätsklinikum Münster, Münster, , Germany
Mathias-Spital Rheine, Rheine, , Germany
"Hippokratio" Hospital of Athens, 2nd Internal Medicine Clin, Athens, , Greece
General Hospital of Chest Diseases Sotiria, Athens, , Greece
University General Hospital of Heraklion, Heraklion, , Greece
University Hospital of Larisa, Oncology Clinic, Larisa, , Greece
General Hospital of Larissa, Larisa, , Greece
Metropolitan Hospital, Oncology Clinic, Neo Faliro, Athens, , Greece
General Hospital "G. Papageorgiou", Thessaloniki, , Greece
National Koranyi TBC and Pulm. Internal Med. Clinic, Budapest, , Hungary
Semmelweis University, Budapest, , Hungary
Institute of Chest Diseases Csongrad County,Dpt. Pulmonology, Deszk, , Hungary
Pulmonology Institute of Veszprem County, Farkasgyepu, Farkasgyepü, , Hungary
Aladar Petz County Teaching Hospital, Dept. Pulmonology, Györ, , Hungary
Lung Hospital of Matra, Dept. Pulmonology, Matrahaza, , Hungary
Josa Andras Korhaz, Nyiregyhaza, Nyiregyhaza, , Hungary
University of Pecs, 1st internal Med. Dept., Pulmonology, Pecs, , Hungary
Pest County Lung Hospital, Department No. 3, Törökbalint, , Hungary
Vikram Hospital, Bangalore, , India
V S Hospital, Chennai, , India
Dr. Kamakshi Memorial Hospital, Chennai, , India
Sri Ramachandra Medical College & Research Institute, Chennai, , India
M.S. Patel Cancer Hospital, Karamsad, , India
B. P .Poddar Hospital & Medical Research Ltd., Kolkata, West Bengal, , India
Tata Memorial Hospital, Mumbai, , India
Ruby Hall Clinic, Pune, , India
St James's Hospital, Dublin 8, , Ireland
P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna, Bologna, , Italy
ASST di Cremona, Cremona, , Italy
Spedali Riuniti di Livorno, Livorno, , Italy
Istituto Nazionale Tumori Fondazione Pascale, Napoli, , Italy
Istituto Oncologico Veneto IRCCS, Padova, , Italy
Azienda Ospedaliera di Parma, Parma, , Italy
Azienda Ospedaliera Universitaria Pisana, Pisa, , Italy
Istituto Clinico Humanitas, Rozzano (MI), , Italy
Ospedale San Vincenzo, Taormina (ME), , Italy
Ospedale Molinette, AO Città della Salute e della, Torino, , Italy
A. O. S. Maria della Misericordia, Udine, , Italy
Chungbuk National University Hospital, Cheongju, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Gyeongsang National University Hospital, Jinju, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St.Mary's Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea, St.Vincent's Hospital, Suwon, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
Instituto Nacional de Cancerologia, Mexico, , Mexico
Hospital y Clínica OCA S. A. de C. V., Monterrey, , Mexico
Centro Hemato-Oncologico Privado de Toluca S.A. de C.V., Toluca, , Mexico
Jeroen Bosch Ziekenhuis-Hertogenbosch, 's-HERTOGENBOSCH, , Netherlands
Rijnstate Hospital, Arnhem, , Netherlands
Amphia Ziekenhuis, Breda, , Netherlands
Catharina Ziekenhuis, Eindhoven, , Netherlands
METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht, Maastricht, , Netherlands
St. Antonius ziekenhuis, locatie Nieuwegein, Nieuwegein, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE, Coimbra, , Portugal
CHLN, EPE - Hospital de Santa Maria, Lisboa, , Portugal
IPO Lisboa Francisco Gentil, EPE, Lisboa, , Portugal
IPO Porto Francisco Gentil, EPE, Porto, , Portugal
Centro Hospitalar São João,EPE, Porto, , Portugal
Centro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia, , Portugal
National Cancer Centre, Singapore, , Singapore
Johns Hopkins Singapore International Medical Centre, Singapore, , Singapore
Hospital A Coruña, A Coruña, , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital La Paz, Madrid, , Spain
Hospital Regional Universitario de Málaga, Malaga, , Spain
Hospital Virgen de la Victoria, Malaga, , Spain
Hospital Clínico de Valencia, Valencia, , Spain
Hospital Clínico Universitario Lozano Blesa, Zaragoza, , Spain
Chang Gung Memorial Hospital Chiayi, Chiayi, , Taiwan
Buddhist Tzu Chi General Hospital, Chiayi, , Taiwan
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Koo Foundation Sun Yet-Sen Cancer Center, Taipei, , Taiwan
Taipe Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital(TaoYuan), Taoyuan, , Taiwan
Akdeniz Universitesi Tip Fakultesi, Antalya, , Turkey
Uludag Universitesi Tip Fakultesi, Bursa, Bursa, , Turkey
Dicle Universitesi Tip Fakultesi, Diyarbakir, , Turkey
Gaziantep Univ. Tip Fakultesi Tibbi Onkoloji Bilim Dali, Gaziantep, , Turkey
Kartal Egitim Ve Arastirma Hastanesi, Istanbul, , Turkey
Yedikule Gog. Hst. EAH, Istanbul, , Turkey
Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali, Izmir, , Turkey
Dr.Suat Seren EAH, Izmir, , Turkey
Queen Elizabeth Hospital, Birmingham, , United Kingdom
Royal Devon and Exeter Hospital, Exeter, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Harrogate District Hospital, Harrogate, , United Kingdom
Royal Free Hospital, London, , United Kingdom
The Royal Marsden Hospital, London, , United Kingdom
Maidstone Hospital, Kent Oncology Centre, Maidstone, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Scarborough Hospital, Scarborough, , United Kingdom
The Royal Marsden Hospital, Sutton, , United Kingdom
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR