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)

Carcinoma, Non-Small-Cell Lung Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853826
• Other study ID #: 1200.55
• Secondary ID: 2009-017661-34
• Status: Completed
• Phase: Phase 3
• Start date: July 17, 2013
• Est. completion date: March 6, 2024

Study information

• Verified date: March 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 481
• Est. completion date: March 6, 2024
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• afatinib
Patients will receive afatinib once daily

Locations

Country	Name	City	State
Australia	Sunshine Hospital	AT Albans	Victoria
Australia	St John of God Murdoch	Murdoch	Western Australia
Australia	The Prince of Wales Hospital	Randwick	New South Wales
Austria	Medical University of Graz State Hospital - University Hospital Graz	Graz
Austria	Ordensklinikum Linz GmbH - Barmherzige Schwestern	Linz
Austria	Klinikum Wels - Grieskirchen GmbH	Wels
Austria	Klinik Penzing SMZ Baumgartner Hoehe	Wien
Czechia	University Hospital Brno	Brno
Czechia	Hospital Hradec Kralove	Hradec Kralove
Czechia	University Hospital Ostrava	Ostrava
Czechia	University Hospital Plzen, Plzen-Bory	Plzen
Greece	Chest Hospital of Athens "Sotiria"	Athens
Greece	Metropolitan Hospital, Oncology Clinic	N. Faliro
Greece	General Oncology Hospital "Agioi Anargyri"	Nea Kifisia
Greece	General Hospital of Thessaloniki "G. Papanikolaou"	Thessaloniki
Hungary	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	Szekesfehervar
Israel	Soroka Univ. Medical Center	Beer Sheva
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center Beilinson	Petah Tikva
Israel	The Chaim Sheba Medical Center Tel HaShomer	Tel Hashomer
Israel	Sourasky Medical Center	Tel-Aviv
Italy	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	Firenze
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	ASST Grande Ospedale Metropolitano Niguarda	Milano
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano
Italy	IRCCS Fondazione Ospedale Maggiore	Milano
Italy	IRCCS San Raffaele	Milano
Italy	Istituto Europeo di Oncologia	Milano
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	Padova
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	A.O. San Camillo Forlanini	Roma
Italy	Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza	Roma
Italy	Istittuo Nazionale Tumori Regina Elena - IRCCS	Roma
Italy	Poli Univ A. Gemelli	Roma
Italy	Università Campus Bio-Medico - ROMA	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
Poland	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	Warszawa
Portugal	ULS de Coimbra, E.P.E.	Coimbra
Portugal	Centro Hospitalar Lisboa Norte Hospital Pulido Valente	Lisboa
Portugal	IPO Lisboa Francisco Gentil, EPE	Lisboa
Portugal	IPO Porto Francisco Gentil, EPE	Porto
Portugal	ULS de Gaia/Espinho, EPE	Vila Nova de Gaia
Russian Federation	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	Moscow City Oncology Dispensary, Moscow	Moscow
Russian Federation	Clinical Oncology Center	Omsk
Russian Federation	FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF	St. Petersburg
Russian Federation	St. Petersburg GUZ City Clinical Oncology Dispensary	St. Petersburg
Spain	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 Clínic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Universitario Reina Sofía	Cordoba
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	Fundación Jiménez Díaz	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital La Princesa	Madrid
Spain	Hospital Ramón y Cajal	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 de Son Llàtzer	Palma de Mallorca
Spain	Hospital Son Espases	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 Clínico de Valencia	Valencia
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital Politècnic La Fe	Valencia
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Australia,  Austria,  Czechia,  Greece,  Hungary,  Israel,  Italy,  Poland,  Portugal,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events according to Common Terminology Criteria (CTCAE Version 3)		up to 24 months

External Links

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