LUME BioNIS: a Biomarker Study in Patients With NSCLC
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.
1 other identifier
observational
260
13 countries
71
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
Typical duration for all trials
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2016
CompletedFirst Posted
Study publicly available on registry
February 2, 2016
CompletedStudy Start
First participant enrolled
March 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2019
CompletedResults Posted
Study results publicly available
September 24, 2020
CompletedSeptember 24, 2020
September 1, 2020
3.5 years
January 29, 2016
September 2, 2020
September 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Eligibility Criteria
NSCLC patients under Vargatef® treatment according to label
You may qualify if:
- 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).
You may not qualify if:
- Any contraindication to Vargatef® or docetaxel as specified in their respective labels.
- Patients participating simultaneously in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
LK Krems
Krems, 3500, Austria
AKH - Medical University of Vienna
Vienna, 1090, Austria
Brussels - UNIV Saint-Luc
Brussels, 1200, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
AZ Sint-Lucas - Campus Sint Lucas
Ghent, 9000, Belgium
Ieper - HOSP Jan Yperman
Ieper, 8900, Belgium
Liège - HOSP CHR de la Citadelle
Liège, 4000, Belgium
Charleroi - UNIV CHU de Charleroi
Lodelinsart, 6042, Belgium
Roeselare - HOSP AZ Delta
Roeselare, 8800, Belgium
Herlev and Gentofte Hospital
Herlev, 2730, Denmark
Gesundheit Nord gGmbH | Klinikverbund Bremen
Bremen, 28325, Germany
Florence-Nightingale-Krankenhaus der Kaiserswerther Diakonie
Düsseldorf, 40489, Germany
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927, Germany
Onkologische Schwerpunktpraxis
Kaiserslautern, 67655, Germany
Klinik, Löwenstein
Löwenstein, 74245, Germany
Thoraxzentrum Bezirk Unterfranken
Münnerstadt, 97702, Germany
Klinikum Nürnberg
Nuremberg, 90419, Germany
Pius-Hospital, Oldenburg
Oldenburg, 26121, Germany
Caritas Klinik St. Theresia; Saarbrücken
Saarbrücken, 66113, Germany
SHG-Kliniken Völklingen
Völklingen, 66333, Germany
Athens Hospital of Chest Dis.
Athens, 11527, Greece
University General Hospital of Heraklion
Heraklion, 71110, Greece
European Interbalkan Medical Centre
Thessaloniki, 555 35, Greece
National Koranyi TBC and Pulm. Internal Med. Clinic
Budapest, 1121, Hungary
Lung Hospital of Matra, Dept. Pulmonology
Mátraháza, 3233, Hungary
BAZ County Central Hospital and University Teaching Hospital
Miskolc, 3526, Hungary
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15100, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, 90146, Italy
Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos
Kaunas, LT-50009, Lithuania
National Cancer Institute, Vilnius
Vilnius, 08660, Lithuania
Luxembourg - HOSP CH de Luxembourg
Luxembourg, 1210, Luxembourg
OLVG, locatie Oosterpark
Amsterdam, 1091 AC, Netherlands
Ziekenhuis Gelderse Vallei
Ede, 6716 RP, Netherlands
Martini Ziekenhuis
Groningen, 9728 NT, Netherlands
Sint Jansdal Ziekenhuis
Harderwijk, 3844 DG, Netherlands
Ziekenhuisgroep Twente locatie Hengelo
Hengelo, 7555DL, Netherlands
Tergooi Ziekenhuis
Hilversum, 1213 XZ, Netherlands
Maasstad Ziekenhuis
Rotterdam, 3079 DZ, Netherlands
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Universitario de Burgos
Buegos, 09006, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, 17007, Spain
Complejo Hospitalario de Jaén
Jaén, 23007, Spain
Complejo Hospitalario Universitario Insular - Materno Infantil
Las Palmas de Gran Canaria, 35016, Spain
Hospital Severo Ochoa
Leganes - Madrid, 28911, Spain
Hospital de León
León, 24008, Spain
Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital La Paz
Madrid, 28046, Spain
Hospital de Mataró
Mataró, 08304, Spain
Hospital Son Espases
Palma de Mallorca, 07010, Spain
Complejo Hospitalario de Navarra
Pamplona, 31008, Spain
CS Parc Taulí
Sabadell, 08208, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Hospital Virgen Macarena
Seville, 41071, Spain
Consorci Sanitari de Terrassa - Hospital de Terrassa
Terrassa, 08227, Spain
Hospital Arnau de Vilanova
Valencia, 46015, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47005, Spain
Gävle Sjukhus
Gävle, 801 87, Sweden
Universitetssjukhuset, Linköping
Linköping, 581 85, Sweden
Karolinska Univ. sjukhuset
Stockholm, 171 76, Sweden
Akademiska sjukhuset
Uppsala, 751 85, Sweden
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
Clatterbridge Cancer Centre
Bebington, Wirral, CH63 4JY, United Kingdom
West Suffolk Hospital
Bury St Edmunds, IP33 2QZ, United Kingdom
Royal Devon and Exeter Hospital
Exeter, EX2 5DW, United Kingdom
Ipswich Hospital
Ipswich, IP4 5PD, United Kingdom
Airedale General Hospital
Keighley, BD20 6TD, United Kingdom
James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Biospecimen
FPE tumour tissue and one blood sample. A buccal swab may replace the blood sample if not available.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The planned number of 250 overall survival events could not be reached. Therefore, in agreement with the European Medicines Agency (EMA), the study was analysed earlier.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Centre
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2016
First Posted
February 2, 2016
Study Start
March 9, 2016
Primary Completion
September 3, 2019
Study Completion
September 3, 2019
Last Updated
September 24, 2020
Results First Posted
September 24, 2020
Record last verified: 2020-09