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 treated-patients Afatinib Patients diagnosed with EGFR mutation positive non-small cell lung cancer (NSCLC) locally advanced or metastatic who have never been treated with EGFR tyrosine kinase inhibitors (TKI) received a daily dose of 40 milligrams (mg) of afatinib (Giotrif®), in the form of film-coated tablet over a 28 day cycle. Afatinib was taken orally with 250 milliliters (mL) of water at the same time of the day and without eating anything for at least 3 hours. Patients continued on treatment for as long as there was no disease progression or no other trial withdrawal criteria. The dose was reduced to 30 mg or 20 mg once daily when the initial dose was not tolerated by the patient.
- Primary Outcome Measures
Name Time Method Number of Patients With Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 From first drug administration to last drug administration plus 28 days of residual effect period. Up to 3866 days. Number of patients with any treatment emergent adverse event (AE) according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
- 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
🇭🇺Farkasgyepü, Hungary
MS Clinsearch, Private Practice
🇵🇱Lublin, Poland
Institute of Chest Diseases Csongrad County,Dpt. Pulmonology
🇭🇺Deszk, Hungary
Fejer County Saint George University Teaching Hospital
🇭🇺Szekesfehervar, 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
🇭🇺Budapest, 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 Sofía
🇪🇸Cordoba, Spain
Hospital Clínic 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 Díaz
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Clínico 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 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 Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain