Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
A Non-interventional Biomarker Study in Patients With Non-Small Cell Lung Cancer (NSCLC) of Adenocarcinoma Tumour Histology Eligible for Treatment With Vargatef® According to the Approved Label.
| NCT number | NCT02671422 |
| Other study ID # | 1199.223 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 9, 2016 |
| Est. completion date | September 3, 2019 |
| Verified date | September 2020 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
At present there are no approved predictive tumour- or serum-derived biomarkers guiding usage of anti-angiogenic therapies in patients with adenocarcinoma of NSCLC.The objective of this NIS is to examine whether genetic/genomic markers (alone or combined with clinical covariates) could be used to predict OS in NSCLC patients eligible for treatment with Vargatef®. The investigations in this study are exploratory in nature and considered to be hypothesis generating. The results from these investigations may help to expand our understanding of the disease and the response to Vargatef®.
| Status | Completed |
| Enrollment | 260 |
| Est. completion date | September 3, 2019 |
| Est. primary completion date | September 3, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: - Age = 18 years. - Women and men with locally advanced, metastatic or locally recurrent NSCLC with histology of adenocarcinoma. - Signed and dated written informed consent. - Vargatef ® is initiated and administered in accordance with the SPC. - Available fixed and paraffin embedded (FPE) tumour tissue routinely obtained at diagnosis and/or at re-biopsy before the initiation of the first line treatment (either block or slides, minimum of 10 slides and up to 20 slides if possible at 5µm thickness). Exclusion criteria: - Any contraindication to Vargatef® or docetaxel as specified in their respective labels. - Vargatef® initiated more than 7 days prior to inclusion in this NIS. - Patients participating simultaneously in a clinical trial. |
| Country | Name | City | State |
|---|---|---|---|
| Austria | LK Krems | Krems | |
| Austria | AKH - Medical University of Vienna | Wien | |
| Belgium | Brussels - UNIV Saint-Luc | Bruxelles | |
| Belgium | AZ Maria Middelares | Gent | |
| Belgium | AZ Sint-Lucas - Campus Sint Lucas | Gent | |
| Belgium | Ieper - HOSP Jan Yperman | Ieper | |
| Belgium | Liège - HOSP CHR de la Citadelle | Liège | |
| Belgium | Charleroi - UNIV CHU de Charleroi | Lodelinsart | |
| Belgium | Roeselare - HOSP AZ Delta | Roeselare | |
| Denmark | Herlev and Gentofte Hospital | Herlev | |
| Germany | Gesundheit Nord gGmbH | Klinikverbund Bremen | Bremen | |
| Germany | Florence-Nightingale-Krankenhaus der Kaiserswerther Diakonie | Düsseldorf | |
| Germany | Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH | Großhansdorf | |
| Germany | Onkologische Schwerpunktpraxis | Kaiserslautern | |
| Germany | Klinik, Löwenstein | Löwenstein | |
| Germany | Thoraxzentrum Bezirk Unterfranken | Münnerstadt | |
| Germany | Klinikum Nürnberg | Nürnberg | |
| Germany | Pius-Hospital, Oldenburg | Oldenburg | |
| Germany | Caritas Klinik St. Theresia; Saarbrücken | Saarbrücken | |
| Germany | SHG-Kliniken Völklingen | Völklingen | |
| Greece | Athens Hospital of Chest Dis. | Athens | |
| Greece | University General Hospital of Heraklion | Heraklion | |
| Greece | European Interbalkan Medical Centre | Thessaloniki | |
| Hungary | National Koranyi TBC and Pulm. Internal Med. Clinic | Budapest | |
| Hungary | Lung Hospital of Matra, Dept. Pulmonology | Matrahaza | |
| Hungary | BAZ County Central Hospital and University Teaching Hospital | Miskolc | |
| Italy | Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo | Alessandria | |
| Italy | Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello | Palermo | |
| Lithuania | Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos | Kaunas | |
| Lithuania | National Cancer Institute, Vilnius | Vilnius | |
| Luxembourg | Luxembourg - HOSP CH de Luxembourg | Luxembourg | |
| Netherlands | OLVG, locatie Oosterpark | Amsterdam | |
| Netherlands | Ziekenhuis Gelderse Vallei | EDE | |
| Netherlands | Martini Ziekenhuis | Groningen | |
| Netherlands | Sint Jansdal Ziekenhuis | Harderwijk | |
| Netherlands | Ziekenhuisgroep Twente locatie Hengelo | Hengelo | |
| Netherlands | Tergooi Ziekenhuis | Hilversum | |
| Netherlands | Maasstad Ziekenhuis | Rotterdam | |
| Spain | Hospital General Universitario de Alicante | Alicante | |
| Spain | Hospital Universitario de Burgos | Buegos | |
| Spain | Hospital Universitari de Girona Doctor Josep Trueta | Girona | |
| Spain | Complejo Hospitalario de Jaén | Jaén | |
| Spain | Complejo Hospitalario Universitario Insular - Materno Infantil | Las Palmas de Gran Canaria | |
| Spain | Hospital Severo Ochoa | Leganes - Madrid | |
| Spain | Hospital de León | León | |
| Spain | Hospital Universitario Lucus Augusti | Lugo | |
| Spain | Hospital Clínico San Carlos | Madrid | |
| Spain | Hospital La Paz | Madrid | |
| Spain | Hospital de Mataró | Mataró | |
| Spain | Hospital Son Espases | Palma de Mallorca | |
| Spain | Complejo Hospitalario de Navarra | Pamplona | |
| Spain | CS Parc Taulí | Sabadell | |
| Spain | Hospital Universitario Marqués de Valdecilla | Santander | |
| Spain | Hospital Virgen del Rocío | Sevilla | |
| Spain | Hospital Virgen Macarena | Sevilla | |
| Spain | Consorci Sanitari de Terrassa - Hospital de Terrassa | Terrassa | |
| Spain | Hospital Arnau de Vilanova | Valencia | |
| Spain | Hospital Clínico Universitario de Valladolid | Valladolid | |
| Sweden | Gävle Sjukhus | Gävle | |
| Sweden | Universitetssjukhuset, Linköping | Linköping | |
| Sweden | Karolinska Univ. sjukhuset | Stockholm | |
| Sweden | Akademiska sjukhuset | Uppsala | |
| United Kingdom | Aberdeen Royal Infirmary | Aberdeen | |
| United Kingdom | Clatterbridge Cancer Centre | Bebington, Wirral | |
| United Kingdom | West Suffolk Hospital | Bury St Edmunds | |
| United Kingdom | Royal Devon and Exeter Hospital | Exeter | |
| United Kingdom | Ipswich Hospital | Ipswich | |
| United Kingdom | Airedale General Hospital | Keighley | |
| United Kingdom | James Cook University Hospital | Middlesbrough | |
| United Kingdom | Freeman Hospital | Newcastle Upon Tyne | |
| United Kingdom | Derriford Hospital | Plymouth |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Austria, Belgium, Denmark, Germany, Greece, Hungary, Italy, Lithuania, Luxembourg, Netherlands, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Overall Survival (OS) Event | Overall survival (OS) was defined as the time from start of entering the study to time of death. For the analysis of overall survival, participants were censored at the date of the last contact if the physician was no longer able to contact a participants or caregiver, and the vital status could not otherwise be determined. Enrolled participants who never received the combination therapy of docetaxel and Vargatef® were censored on the day of enrolment. Calculation of OS: For participants with known date of death: OS [days] = date of death - date of treatment start + 1 For participants known to be alive by the end of the study or at follow-up visit: OS (censored) [days] = date of last contact when the Patient was known to be alive - date of treatment start + 1. |
From start of entering the study until death or last contact date, up to 42 months. |
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