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)

PHASE3CompletedINTERVENTIONAL
Enrollment

481

Participants

Timeline

Start Date

July 17, 2013

Primary Completion Date

March 6, 2024

Study Completion Date

March 6, 2024

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

Afatinib

Patients 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.

Trial Locations (118)

1121

Koranyi National Institute For Pulmonolgy, Budapest

1140

Klinik Penzing SMZ Baumgartner Hoehe, Vienna

2031

The Prince of Wales Hospital, Randwick

3021

Sunshine Hospital, AT Albans

4010

Ordensklinikum Linz GmbH - Barmherzige Schwestern, Linz

4600

Klinikum Wels - Grieskirchen GmbH, Wels

6150

St John of God Murdoch, Murdoch

6772

Institute of Chest Diseases Csongrad County,Dpt. Pulmonology, Deszk

8000

Fejer County Saint George University Teaching Hospital, Székesfehérvár

8036

Medical University of Graz State Hospital - University Hospital Graz, Graz

8582

Pulmonology Institute of Veszprem County, Farkasgyepu, Farkasgyepü

10043

Azienda Sanitaria Ospedale S. Luigi Gonzaga, Orbassano (TO)

10129

AO Città della Salute e Scienza, Torino

11527

"Chest Hospital of Athens Sotiria", Athens

14004

Hospital Universitario Reina Sofía, Córdoba

14564

"General Oncology Hospital Agioi Anargyri", Nea Kifissia

15006

Hospital A Coruña, A Coruña

15100

Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo, Alessandria

15706

Hospital Clínico de Santiago, Santiago de Compostela

16132

Azienda Ospedaliera San Martino, Genova

18014

Hospital Universitario Virgen de las Nieves, Granada

18547

Metropolitan Hospital, Oncology Clinic, N. Faliro

20052

A.O. San Gerardo di Monza, Monza (MI)

20122

IRCCS Fondazione Ospedale Maggiore, Milan

20132

IRCCS San Raffaele, Milan

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

Istituto Europeo di Oncologia, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

24127

A. O. Ospedali Riuniti di Bergamo, Bergamo

25123

A.O. Spedali Civili di Brescia, Brescia

28006

Hospital La Princesa, Madrid

28007

Hospital General Universitario Gregorio Marañón, Madrid

28034

Hospital Ramón y Cajal, Madrid

28040

Fundación Jiménez Díaz, Madrid

Hospital Clínico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital La Paz, Madrid

28100

A.O.U. Maggiore della Carita', Novara

28222

Hospital Puerta de Hierro, Majadahonda (Madrid)

29010

Hospital Regional Universitario de Málaga, Málaga

Hospital Virgen de la Victoria, Málaga

31008

Complejo Hospitalario de Navarra, Pamplona

31100

Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO, Treviso

33011

Hospital Central de Asturias, Oviedo

33081

Centro di riferimento Oncologico, Aviano (PN)

33100

A. O. S. Maria della Misericordia, Udine

35128

Istituto Oncologico Veneto IRCCS, Padua

37126

Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona, Verona

38320

Hospital de Canarias, La Laguna - Tenerife

39100

Ospedale Centrale di Bolzano, Bolzano

40026

Osp. S. Maria della Scaletta, Imola

40138

Policlinico S. Orsola Malpighi, Bologna

41013

Hospital Virgen del Rocío, Seville

41100

Università di Modena e Reggio Emilia, Modena

43100

Azienda Ospedaliera di Parma, Parma

44281

Meir Medical Center, Kfar Saba

46009

Hospital Politècnic La Fe, Valencia

46010

Hospital Clínico de Valencia, Valencia

46014

Hospital General Universitario de Valencia, Valencia

47014

Istituto Scientifico Romagnolo, Meldola (FC)

48121

Ospedale S. Maria delle Croci, Ravenna

48903

Hospital Universitario de Cruces, Barakaldo (Bilbao)

50009

Hospital Clínico Universitario Lozano Blesa, Zaragoza

Hospital Miguel Servet, Zaragoza

50139

Azienda Ospedaliera Careggi, Florence

52621

The Chaim Sheba Medical Center Tel HaShomer, Tel Litwinsky

55100

Osp. Campo di Marte, Lucca

56126

Azienda Ospedaliera Universitaria Pisana, Pisa

57010

"General Hospital of Thessaloniki G. Papanikolaou", Thessaloniki

60020

Az. Ospedaliere Umberto I di Ancona, Ancona

64239

Sourasky Medical Center, Tel Aviv

70124

Istituto Tumori Giovanni Paolo II, Bari

73100

Azienda Ospedaliera Vito Fazzi, Lecce

80131

Istituto Nazionale IRCCS Tumori Fondazione Pascale, Napoli

Osp. dei Colli Monaldi-Cotugno, Napoli

83100

A. O. Giuseppe Moscati, Avellino

84101

Soroka Univ. Medical Center, Beersheba

85028

Irccs Crob, Rionero in Vulture (PZ)

90127

"A.O. Univ. Policlinico Paolo Giaccone", Palermo

90146

Casa di Cura La Maddalena, Palermo

111033

Moscow City Oncology Dispensary, Moscow, Moscow

115478

"FSBI N.N Blokhin Med.Res.Cent.Onc.MoH of RF", Moscow

197022

St. Petersburg GUZ City Clinical Oncology Dispensary, Saint Petersburg

197758

"FSBI N.N. Petrov National Medical Research Center of Oncology of MoH of RF", Saint Petersburg

420029

"St.Auton.Heal.Inst.Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan", Kazan'

4941492

Rabin Medical Center Beilinson, Petah Tikva

625 00

University Hospital Brno, Brno

500 05

Hospital Hradec Kralove, Hradec Králové

708 52

University Hospital Ostrava, Ostrava

305 00

University Hospital Plzen, Plzen-Bory, Pilsen

06132

Ospedale S.Maria della Misericordia, AO di Perugia, Perugia

00128

Università Campus Bio-Medico - ROMA, Roma

00144

Istittuo Nazionale Tumori Regina Elena - IRCCS, Roma

00152

A.O. San Camillo Forlanini, Roma

00168

Poli Univ A. Gemelli, Roma

00189

Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza, Roma

05100

"Azienda Ospedaliera Santo Maria", Terni

85-796

Oncology Center na F. Lukaszczyka, Bydgoszcz

80-952

University Clinical Center, Gdansk, Gdansk

93-513

Provincial Specialist M. Kopernik Hospital, Lodz

20-090

MS Clinsearch, Private Practice, Lublin

60-693

MED POLONIA SP Z O O, Clinical Trials Department,Poznan, Poznan

02-781

Oncology Center-Maria Sklodowska-Curie Institute, Warsaw

3041-801

ULS de Coimbra, E.P.E., Coimbra

1099-023

IPO Lisboa Francisco Gentil, EPE, Lisbon

1769-001

Centro Hospitalar Lisboa Norte Hospital Pulido Valente, Lisbon

4200-072

IPO Porto Francisco Gentil, EPE, Porto

4434-502

ULS de Gaia/Espinho, EPE, Vila Nova de Gaia

640 013

Clinical Oncology Center, Omsk

03010

Hospital General Universitario de Alicante, Alicante

08916

Hospital Germans Trias i Pujol, Badalona

08003

Hospital del Mar, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

08036

Hospital Clínic de Barcelona, Barcelona

08041

Hospital Santa Creu i Sant Pau, Barcelona

08908

Hospital Duran i Reynals, L'Hospitalet de Llobregat

07120

Hospital Son Espases, Palma de Mallorca

07198

Hospital de Son Llàtzer, Palma de Mallorca

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY