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)
Verified date | March 2024 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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) |
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 |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Australia, Austria, Czechia, Greece, Hungary, Israel, Italy, Poland, Portugal, Russian Federation, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events according to Common Terminology Criteria (CTCAE Version 3) | up to 24 months |
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