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)
- Registration Number
- NCT01853826
- Lead Sponsor
- Boehringer Ingelheim
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 481
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description afatinib afatinib Patients will receive afatinib once daily
- Primary Outcome Measures
Name Time Method Adverse Events according to Common Terminology Criteria (CTCAE Version 3) up to 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (118)
A.O. Univ. Policlinico "Paolo Giaccone"
🇮🇹Palermo, Italy
University Hospital Ostrava
🇨🇿Ostrava, Czechia
Rabin Medical Center Beilinson
🇮🇱Petah Tikva, Israel
IRCCS San Raffaele
🇮🇹Milano, Italy
Università Campus Bio-Medico - ROMA
🇮🇹Roma, Italy
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
A.O. San Gerardo di Monza
🇮🇹Monza (MI), Italy
Azienda Ospedaliera Universitaria Pisana
🇮🇹Pisa, Italy
Ordensklinikum Linz GmbH - Barmherzige Schwestern
🇦🇹Linz, Austria
Osp. Campo di Marte
🇮🇹Lucca, Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale
🇮🇹Napoli, Italy
Azienda Sanitaria Ospedale S. Luigi Gonzaga
🇮🇹Orbassano (TO), Italy
Istituto Oncologico Veneto IRCCS
🇮🇹Padova, Italy
Azienda Ospedaliera di Parma
🇮🇹Parma, Italy
Hospital Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Azienda Ospedaliera "Santo Maria"
🇮🇹Terni, Italy
Casa di Cura La Maddalena
🇮🇹Palermo, Italy
Moscow City Oncology Dispensary, Moscow
🇷🇺Moscow, Russian Federation
IPO Lisboa Francisco Gentil, EPE
🇵🇹Lisboa, Portugal
MED POLONIA SP Z O O, Clinical Trials Department,Poznan
🇵🇱Poznan, Poland
Oncology Center-Maria Sklodowska-Curie Institute
🇵🇱Warszawa, Poland
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
🇵🇹Lisboa, Portugal
Clinical Oncology Center
🇷🇺Omsk, Russian Federation
Hospital de Canarias
🇪🇸La Laguna - Tenerife, Spain
ULS de Coimbra, E.P.E.
🇵🇹Coimbra, Portugal
ULS de Gaia/Espinho, EPE
🇵🇹Vila Nova de Gaia, Portugal
Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona
🇮🇹Verona, Italy
Hospital A Coruña
🇪🇸A Coruña, Spain
Hospital Universitario de Cruces
🇪🇸Barakaldo (Bilbao), Spain
St. Petersburg GUZ City Clinical Oncology Dispensary
🇷🇺St. Petersburg, Russian Federation
IPO Porto Francisco Gentil, EPE
🇵🇹Porto, Portugal
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
St John of God Murdoch
🇦🇺Murdoch, Western Australia, Australia
Pulmonology Institute of Veszprem County, Farkasgyepu
ðŸ‡ðŸ‡ºFarkasgyepü, Hungary
MS Clinsearch, Private Practice
🇵🇱Lublin, Poland
Institute of Chest Diseases Csongrad County,Dpt. Pulmonology
ðŸ‡ðŸ‡ºDeszk, Hungary
Fejer County Saint George University Teaching Hospital
ðŸ‡ðŸ‡ºSzekesfehervar, Hungary
Klinik Penzing SMZ Baumgartner Hoehe
🇦🇹Wien, Austria
Klinikum Wels - Grieskirchen GmbH
🇦🇹Wels, Austria
Oncology Center na F. Lukaszczyka
🇵🇱Bydgoszcz, Poland
Koranyi National Institute For Pulmonolgy
ðŸ‡ðŸ‡ºBudapest, Hungary
A. O. Giuseppe Moscati
🇮🇹Avellino, Italy
A. O. Ospedali Riuniti di Bergamo
🇮🇹Bergamo, Italy
Ospedale Centrale di Bolzano
🇮🇹Bolzano, Italy
Osp. S. Maria della Scaletta
🇮🇹Imola, Italy
Azienda Ospedaliera Vito Fazzi
🇮🇹Lecce, Italy
Ospedale S.Maria della Misericordia, AO di Perugia
🇮🇹Perugia, Italy
Ospedale S. Maria delle Croci
🇮🇹Ravenna, Italy
Irccs Crob
🇮🇹Rionero In Vulture (PZ), 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
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
The Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Sunshine Hospital
🇦🇺AT Albans, Victoria, Australia
Medical University of Graz State Hospital - University Hospital Graz
🇦🇹Graz, Austria
University Hospital Brno
🇨🇿Brno, Czechia
Chest Hospital of Athens "Sotiria"
🇬🇷Athens, Greece
University Hospital Plzen, Plzen-Bory
🇨🇿Plzen, Czechia
Metropolitan Hospital, Oncology Clinic
🇬🇷N. Faliro, Greece
General Oncology Hospital "Agioi Anargyri"
🇬🇷Nea Kifisia, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
🇬🇷Thessaloniki, Greece
Soroka Univ. Medical Center
🇮🇱Beer Sheva, Israel
Meir Medical Center
🇮🇱Kfar Saba, 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
Centro di riferimento Oncologico
🇮🇹Aviano (PN), Italy
Istituto Tumori Giovanni Paolo II
🇮🇹Bari, Italy
Policlinico S. Orsola Malpighi
🇮🇹Bologna, Italy
A.O. Spedali Civili di Brescia
🇮🇹Brescia, Italy
Azienda Ospedaliera Careggi
🇮🇹Firenze, Italy
Azienda Ospedaliera San Martino
🇮🇹Genova, Italy
IRCCS Fondazione Ospedale Maggiore
🇮🇹Milano, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Istituto Scientifico Romagnolo
🇮🇹Meldola (FC), Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
Osp. dei Colli Monaldi-Cotugno
🇮🇹Napoli, Italy
Università di Modena e Reggio Emilia
🇮🇹Modena, Italy
A.O.U. Maggiore della Carita'
🇮🇹Novara, 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
University Clinical Center, Gdansk
🇵🇱Gdansk, Poland
Provincial Specialist M. Kopernik Hospital
🇵🇱Lodz, Poland
St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
🇷🇺Kazan, Russian Federation
FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
🇷🇺Moscow, Russian Federation
FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF
🇷🇺St. Petersburg, Russian Federation
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Reina SofÃa
🇪🇸Cordoba, Spain
Hospital ClÃnic de Barcelona
🇪🇸Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Duran i Reynals
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital La Princesa
🇪🇸Madrid, Spain
Fundación Jiménez DÃaz
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital ClÃnico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸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 Llà tzer
🇪🇸Palma de Mallorca, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Spain
Hospital ClÃnico de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Virgen del RocÃo
🇪🇸Sevilla, Spain
Hospital Politècnic La Fe
🇪🇸Valencia, Spain
Hospital ClÃnico de Valencia
🇪🇸Valencia, Spain
Hospital ClÃnico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain