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Brief Title: An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
Official Title: An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
Study ID: NCT01853826
Brief Summary: To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Prince of Wales Hospital, Randwick, New South Wales, Australia
Sunshine Hospital, AT Albans, Victoria, Australia
St John of God Murdoch, Murdoch, Western Australia, Australia
Medical University of Graz State Hospital - University Hospital Graz, Graz, , Austria
Ordensklinikum Linz GmbH - Barmherzige Schwestern, Linz, , Austria
Klinikum Wels - Grieskirchen GmbH, Wels, , Austria
Klinik Penzing SMZ Baumgartner Hoehe, Wien, , Austria
University Hospital Brno, Brno, , Czechia
Hospital Hradec Kralove, Hradec Kralove, , Czechia
University Hospital Ostrava, Ostrava, , Czechia
University Hospital Plzen, Plzen-Bory, Plzen, , Czechia
Chest Hospital of Athens "Sotiria", Athens, , Greece
Metropolitan Hospital, Oncology Clinic, N. Faliro, , Greece
General Oncology Hospital "Agioi Anargyri", Nea Kifisia, , Greece
General Hospital of Thessaloniki "G. Papanikolaou", Thessaloniki, , Greece
Koranyi National Institute For Pulmonolgy, Budapest, , Hungary
Institute of Chest Diseases Csongrad County,Dpt. Pulmonology, Deszk, , Hungary
Pulmonology Institute of Veszprem County, Farkasgyepu, Farkasgyepü, , Hungary
Fejer County Saint George University Teaching Hospital, Szekesfehervar, , Hungary
Soroka Univ. Medical Center, Beer Sheva, , Israel
Meir Medical Center, Kfar Saba, , Israel
Rabin Medical Center Beilinson, Petah Tikva, , Israel
The Chaim Sheba Medical Center Tel HaShomer, Tel Hashomer, , Israel
Sourasky Medical Center, Tel-Aviv, , Israel
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo, Alessandria, , Italy
Az. Ospedaliere Umberto I di Ancona, Ancona, , Italy
A. O. Giuseppe Moscati, Avellino, , Italy
Centro di riferimento Oncologico, Aviano (PN), , Italy
Istituto Tumori Giovanni Paolo II, Bari, , Italy
A. O. Ospedali Riuniti di Bergamo, Bergamo, , Italy
Policlinico S. Orsola Malpighi, Bologna, , Italy
Ospedale Centrale di Bolzano, Bolzano, , Italy
A.O. Spedali Civili di Brescia, Brescia, , Italy
Azienda Ospedaliera Careggi, Firenze, , Italy
Azienda Ospedaliera San Martino, Genova, , Italy
Osp. S. Maria della Scaletta, Imola, , Italy
Azienda Ospedaliera Vito Fazzi, Lecce, , Italy
Osp. Campo di Marte, Lucca, , Italy
Istituto Scientifico Romagnolo, Meldola (FC), , Italy
IRCCS Fondazione Ospedale Maggiore, Milano, , Italy
IRCCS San Raffaele, Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Università di Modena e Reggio Emilia, Modena, , Italy
A.O. San Gerardo di Monza, Monza (MI), , Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale, Napoli, , Italy
Osp. dei Colli Monaldi-Cotugno, Napoli, , Italy
A.O.U. Maggiore della Carita', Novara, , Italy
Azienda Sanitaria Ospedale S. Luigi Gonzaga, Orbassano (TO), , Italy
Istituto Oncologico Veneto IRCCS, Padova, , Italy
A.O. Univ. Policlinico "Paolo Giaccone", Palermo, , Italy
Casa di Cura La Maddalena, Palermo, , Italy
Azienda Ospedaliera di Parma, Parma, , Italy
Ospedale S.Maria della Misericordia, AO di Perugia, Perugia, , Italy
Azienda Ospedaliera Universitaria Pisana, Pisa, , Italy
Ospedale S. Maria delle Croci, Ravenna, , Italy
Irccs Crob, Rionero In Vulture (PZ), , Italy
Università Campus Bio-Medico - ROMA, Roma, , Italy
Istittuo Nazionale Tumori Regina Elena - IRCCS, Roma, , Italy
A.O. San Camillo Forlanini, Roma, , Italy
Poli Univ A. Gemelli, Roma, , Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza, Roma, , Italy
Azienda Ospedaliera "Santo Maria", Terni, , Italy
AO Città della Salute e Scienza, Torino, , Italy
Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO, Treviso, , Italy
A. O. S. Maria della Misericordia, Udine, , Italy
Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona, Verona, , Italy
Oncology Center na F. Lukaszczyka, Bydgoszcz, , Poland
University Clinical Center, Gdansk, Gdansk, , Poland
Provincial Specialist M. Kopernik Hospital, Lodz, , Poland
MS Clinsearch, Private Practice, Lublin, , Poland
MED POLONIA SP Z O O, Clinical Trials Department,Poznan, Poznan, , Poland
Oncology Center-Maria Sklodowska-Curie Institute, Warszawa, , Poland
ULS de Coimbra, E.P.E., Coimbra, , Portugal
IPO Lisboa Francisco Gentil, EPE, Lisboa, , Portugal
Centro Hospitalar Lisboa Norte Hospital Pulido Valente, Lisboa, , Portugal
IPO Porto Francisco Gentil, EPE, Porto, , Portugal
ULS de Gaia/Espinho, EPE, Vila Nova de Gaia, , Portugal
St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan", Kazan, , Russian Federation
Moscow City Oncology Dispensary, Moscow, Moscow, , Russian Federation
FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF, Moscow, , Russian Federation
Clinical Oncology Center, Omsk, , Russian Federation
St. Petersburg GUZ City Clinical Oncology Dispensary, St. Petersburg, , Russian Federation
FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF, St. Petersburg, , Russian Federation
Hospital A Coruña, A Coruña, , Spain
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Universitario de Cruces, Barakaldo (Bilbao), , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Reina Sofía, Cordoba, , Spain
Hospital Universitario Virgen de las Nieves, Granada, , Spain
Hospital Duran i Reynals, L'Hospitalet de Llobregat, , Spain
Hospital de Canarias, La Laguna - Tenerife, , Spain
Hospital La Princesa, Madrid, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Fundación Jiménez Díaz, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital La Paz, Madrid, , Spain
Hospital Puerta de Hierro, Majadahonda (Madrid), , Spain
Hospital Regional Universitario de Málaga, Malaga, , Spain
Hospital Virgen de la Victoria, Malaga, , Spain
Hospital Central de Asturias, Oviedo, , Spain
Hospital Son Espases, Palma de Mallorca, , Spain
Hospital de Son Llàtzer, Palma de Mallorca, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Hospital Clínico de Santiago, Santiago de Compostela, , Spain
Hospital Virgen del Rocío, Sevilla, , Spain
Hospital Politècnic La Fe, Valencia, , Spain
Hospital Clínico de Valencia, Valencia, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Hospital Clínico Universitario Lozano Blesa, Zaragoza, , Spain
Hospital Miguel Servet, Zaragoza, , Spain
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR