Clinical trial NCT01853826: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-05-15
Enrollment: 481
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion criteria:

Patients with:

* 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:

Patients who or with:

* 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)

Primary outcomes:
measure: Number of Patients With Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
timeFrame: From first drug administration to last drug administration plus 28 days of residual effect period. Up to 3866 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: The Prince of Wales Hospital
state: New South Wales
city: AT Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Murdoch
country: Australia
facility: St John of God Murdoch
state: Western Australia
city: Graz
country: Austria
facility: Medical University of Graz State Hospital - University Hospital Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern
city: Wels
country: Austria
facility: Klinikum Wels - Grieskirchen GmbH
city: Wien
country: Austria
facility: Klinik Penzing SMZ Baumgartner Hoehe
city: Brno
country: Czechia
facility: University Hospital Brno
city: Hradec Kralove
country: Czechia
facility: Hospital Hradec Kralove
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Plzen
country: Czechia
facility: University Hospital Plzen, Plzen-Bory
city: Athens
country: Greece
facility: Chest Hospital of Athens "Sotiria"
city: N. Faliro
country: Greece
facility: Metropolitan Hospital, Oncology Clinic
city: Nea Kifisia
country: Greece
facility: General Oncology Hospital "Agioi Anargyri"
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G. Papanikolaou"
city: Budapest
country: Hungary
facility: Koranyi National Institute For Pulmonolgy
city: Deszk
country: Hungary
facility: Institute of Chest Diseases Csongrad County,Dpt. Pulmonology
city: Farkasgyepü
country: Hungary
facility: Pulmonology Institute of Veszprem County, Farkasgyepu
city: Szekesfehervar
country: Hungary
facility: Fejer County Saint George University Teaching Hospital
city: Beer Sheva
country: Israel
facility: Soroka Univ. Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center Beilinson
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center Tel HaShomer
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: Az. Ospedaliere Umberto I di Ancona
city: Avellino
country: Italy
facility: A. O. Giuseppe Moscati
city: Aviano (PN)
country: Italy
facility: Centro di riferimento Oncologico
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo II
city: Bergamo
country: Italy
facility: A. O. Ospedali Riuniti di Bergamo
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi
city: Bolzano
country: Italy
facility: Ospedale Centrale di Bolzano
city: Brescia
country: Italy
facility: A.O. Spedali Civili di Brescia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Careggi
city: Genova
country: Italy
facility: Azienda Ospedaliera San Martino
city: Imola
country: Italy
facility: Osp. S. Maria della Scaletta
city: Lecce
country: Italy
facility: Azienda Ospedaliera Vito Fazzi
city: Lucca
country: Italy
facility: Osp. Campo di Marte
city: Meldola (FC)
country: Italy
facility: Istituto Scientifico Romagnolo
city: Milano
country: Italy
facility: IRCCS Fondazione Ospedale Maggiore
city: Milano
country: Italy
facility: IRCCS San Raffaele
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Modena
country: Italy
facility: Università di Modena e Reggio Emilia
city: Monza (MI)
country: Italy
facility: A.O. San Gerardo di Monza
city: Napoli
country: Italy
facility: Istituto Nazionale IRCCS Tumori Fondazione Pascale
city: Napoli
country: Italy
facility: Osp. dei Colli Monaldi-Cotugno
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carita'
city: Orbassano (TO)
country: Italy
facility: Azienda Sanitaria Ospedale S. Luigi Gonzaga
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
city: Palermo
country: Italy
facility: A.O. Univ. Policlinico "Paolo Giaccone"
city: Palermo
country: Italy
facility: Casa di Cura La Maddalena
city: Parma
country: Italy
facility: Azienda Ospedaliera di Parma
city: Perugia
country: Italy
facility: Ospedale S.Maria della Misericordia, AO di Perugia
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Ravenna
country: Italy
facility: Ospedale S. Maria delle Croci
city: Rionero In Vulture (PZ)
country: Italy
facility: Irccs Crob
city: Roma
country: Italy
facility: Università Campus Bio-Medico - ROMA
city: Roma
country: Italy
facility: Istittuo Nazionale Tumori Regina Elena - IRCCS
city: Roma
country: Italy
facility: A.O. San Camillo Forlanini
city: Roma
country: Italy
facility: Poli Univ A. Gemelli
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
city: Terni
country: Italy
facility: Azienda Ospedaliera "Santo Maria"
city: Torino
country: Italy
facility: AO Città della Salute e Scienza
city: Treviso
country: Italy
facility: Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO
city: Udine
country: Italy
facility: A. O. S. Maria della Misericordia
city: Verona
country: Italy
facility: Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona
city: Bydgoszcz
country: Poland
facility: Oncology Center na F. Lukaszczyka
city: Gdansk
country: Poland
facility: University Clinical Center, Gdansk
city: Lodz
country: Poland
facility: Provincial Specialist M. Kopernik Hospital
city: Lublin
country: Poland
facility: MS Clinsearch, Private Practice
city: Poznan
country: Poland
facility: MED POLONIA SP Z O O, Clinical Trials Department,Poznan
city: Warszawa
country: Poland
facility: Oncology Center-Maria Sklodowska-Curie Institute
city: Coimbra
country: Portugal
facility: ULS de Coimbra, E.P.E.
city: Lisboa
country: Portugal
facility: IPO Lisboa Francisco Gentil, EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte Hospital Pulido Valente
city: Porto
country: Portugal
facility: IPO Porto Francisco Gentil, EPE
city: Vila Nova de Gaia
country: Portugal
facility: ULS de Gaia/Espinho, EPE
city: Kazan
country: Russian Federation
facility: St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
city: Moscow
country: Russian Federation
facility: Moscow City Oncology Dispensary, Moscow
city: Moscow
country: Russian Federation
facility: FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
city: Omsk
country: Russian Federation
facility: Clinical Oncology Center
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg GUZ City Clinical Oncology Dispensary
city: St. Petersburg
country: Russian Federation
facility: FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF
city: A Coruña
country: Spain
facility: Hospital A Coruña
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barakaldo (Bilbao)
country: Spain
facility: Hospital Universitario de Cruces
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals
city: La Laguna - Tenerife
country: Spain
facility: Hospital de Canarias
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital La Paz
city: Majadahonda (Madrid)
country: Spain
facility: Hospital Puerta de Hierro
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Palma de Mallorca
country: Spain
facility: Hospital de Son Llàtzer
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico de Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Politècnic La Fe
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: