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)
NCT ID: NCT01853826
Last Updated: 2025-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
481 participants
INTERVENTIONAL
2013-07-17
2024-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Afatinib treated-patients
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
* Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution's testing methodology.
* Adequate organ function, defined as all of the following:
1. Absolute Neutrophil Count (ANC) \> 1500/mm3. (ANC \>1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
2. Platelet count \>75,000/mm3
3. Serum creatinine \< 1.5 times of the upper limit of normal
4. Total Bilirubin \< 1.5 times upper limit of (institutional) normal (Patients with Gilbert's syndrome total bilirubin must be \<4 times institutional upper limit of normal).
5. Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) \< three times the upper limit of (institutional) normal (ULN) (if related to liver metastases \< five times ULN).
* Eastern Cooperative Oncology Group (ECOG) score between 0 - 2
* written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law.
Exclusion Criteria
* prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
* anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
* radiotherapy within 14 days prior to drug administration, except as follows:
1. Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
2. Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
* previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
* known pre-existing interstitial lung disease
* meningeal carcinomatosis and symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had Stable Disease (SD) for at least 4 weeks on stable doses of medication)
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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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
Klinik Penzing SMZ Baumgartner Hoehe
Vienna, , Austria
Klinikum Wels - Grieskirchen GmbH
Wels, , Austria
University Hospital Brno
Brno, , Czechia
Hospital Hradec Kralove
Hradec Králové, , Czechia
University Hospital Ostrava
Ostrava, , Czechia
University Hospital Plzen, Plzen-Bory
Pilsen, , Czechia
Chest Hospital of Athens "Sotiria"
Athens, , Greece
Metropolitan Hospital, Oncology Clinic
N. Faliro, , Greece
General Oncology Hospital "Agioi Anargyri"
Nea Kifissia, , 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
Székesfehérvár, , Hungary
Soroka Univ. Medical Center
Beersheba, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center Beilinson
Petah Tikva, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
The Chaim Sheba Medical Center Tel HaShomer
Tel Litwinsky, , 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
Florence, , 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
Milan, , Italy
IRCCS San Raffaele
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , 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
Padua, , 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
Warsaw, , Poland
ULS de Coimbra, E.P.E.
Coimbra, , Portugal
IPO Lisboa Francisco Gentil, EPE
Lisbon, , Portugal
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
Lisbon, , 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', , Russia
Moscow City Oncology Dispensary, Moscow
Moscow, , Russia
FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
Moscow, , Russia
Clinical Oncology Center
Omsk, , Russia
St. Petersburg GUZ City Clinical Oncology Dispensary
Saint Petersburg, , Russia
FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF
Saint Petersburg, , Russia
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
Córdoba, , 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
Málaga, , Spain
Hospital Virgen de la Victoria
Málaga, , 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
Seville, , 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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2009-017661-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1200.55
Identifier Type: -
Identifier Source: org_study_id
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