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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