LUME BioNIS: a Biomarker Study in Patients With NSCLC
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT02671422
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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®.
- Detailed Description
Purpose:
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Overall Survival (OS) Event From start of entering the study until death or last contact date, up to 42 months. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (71)
Hospital de León
🇪🇸León, Spain
Charleroi - UNIV CHU de Charleroi
🇧🇪Lodelinsart, Belgium
AZ Maria Middelares
🇧🇪Gent, Belgium
Ieper - HOSP Jan Yperman
🇧🇪Ieper, Belgium
Luxembourg - HOSP CH de Luxembourg
🇱🇺Luxembourg, Luxembourg
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Universitetssjukhuset, Linköping
🇸🇪Linköping, Sweden
James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
LK Krems
🇦🇹Krems, Austria
AZ Sint-Lucas - Campus Sint Lucas
🇧🇪Gent, Belgium
Liège - HOSP CHR de la Citadelle
🇧🇪Liège, Belgium
Roeselare - HOSP AZ Delta
🇧🇪Roeselare, Belgium
Gesundheit Nord gGmbH | Klinikverbund Bremen
🇩🇪Bremen, Germany
Herlev and Gentofte Hospital
🇩🇰Herlev, Denmark
Brussels - UNIV Saint-Luc
🇧🇪Bruxelles, Belgium
Klinik, Löwenstein
🇩🇪Löwenstein, Germany
Klinikum Nürnberg
🇩🇪Nürnberg, Germany
Pius-Hospital, Oldenburg
🇩🇪Oldenburg, Germany
Caritas Klinik St. Theresia; Saarbrücken
🇩🇪Saarbrücken, Germany
SHG-Kliniken Völklingen
🇩🇪Völklingen, Germany
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
🇮🇹Palermo, Italy
Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos
🇱🇹Kaunas, Lithuania
OLVG, locatie Oosterpark
🇳🇱Amsterdam, Netherlands
Sint Jansdal Ziekenhuis
🇳🇱Harderwijk, Netherlands
Tergooi Ziekenhuis
🇳🇱Hilversum, Netherlands
Maasstad Ziekenhuis
🇳🇱Rotterdam, Netherlands
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Spain
Gävle Sjukhus
🇸🇪Gävle, Sweden
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
Hospital La Paz
🇪🇸Madrid, Spain
AKH - Medical University of Vienna
🇦🇹Wien, Austria
Onkologische Schwerpunktpraxis
🇩🇪Kaiserslautern, Germany
European Interbalkan Medical Centre
🇬🇷Thessaloniki, Greece
BAZ County Central Hospital and University Teaching Hospital
🇭🇺Miskolc, Hungary
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Italy
National Cancer Institute, Vilnius
🇱🇹Vilnius, Lithuania
Hospital Universitario de Burgos
🇪🇸Buegos, Spain
Complejo Hospitalario Universitario Insular - Materno Infantil
🇪🇸Las Palmas de Gran Canaria, Spain
Hospital Severo Ochoa
🇪🇸Leganes - Madrid, Spain
Florence-Nightingale-Krankenhaus der Kaiserswerther Diakonie
🇩🇪Düsseldorf, Germany
Athens Hospital of Chest Dis.
🇬🇷Athens, Greece
University General Hospital of Heraklion
🇬🇷Heraklion, Greece
Martini Ziekenhuis
🇳🇱Groningen, Netherlands
Hospital de Mataró
🇪🇸Mataró, Spain
Hospital Son Espases
🇪🇸Palma de Mallorca, Spain
CS Parc Taulí
🇪🇸Sabadell, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Karolinska Univ. sjukhuset
🇸🇪Stockholm, Sweden
Akademiska sjukhuset
🇸🇪Uppsala, Sweden
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
National Koranyi TBC and Pulm. Internal Med. Clinic
🇭🇺Budapest, Hungary
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
🇩🇪Großhansdorf, Germany
Thoraxzentrum Bezirk Unterfranken
🇩🇪Münnerstadt, Germany
Lung Hospital of Matra, Dept. Pulmonology
🇭🇺Matrahaza, Hungary
Ziekenhuis Gelderse Vallei
🇳🇱EDE, Netherlands
Ziekenhuisgroep Twente locatie Hengelo
🇳🇱Hengelo, Netherlands
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitari de Girona Doctor Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Ipswich Hospital
🇬🇧Ipswich, United Kingdom
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Consorci Sanitari de Terrassa - Hospital de Terrassa
🇪🇸Terrassa, Spain
Airedale General Hospital
🇬🇧Keighley, United Kingdom
Clatterbridge Cancer Centre
🇬🇧Bebington, Wirral, United Kingdom
West Suffolk Hospital
🇬🇧Bury St Edmunds, United Kingdom
Freeman Hospital
🇬🇧Newcastle Upon Tyne, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom