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Spots Global Cancer Trial Database for 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)

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Trial Identification

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

Interventions

afatinib

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Boehringer Ingelheim

Affiliation: Boehringer Ingelheim

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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