Clinical trial NCT02671422: LUME BioNIS: a Biomarker Study in Patients With NSCLC
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-02-02
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NSCLC patients under Vargatef® treatment according to label

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:

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Overall Survival (OS) Event
timeFrame: From start of entering the study until death or last contact date, up to 42 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Krems
country: Austria
facility: LK Krems
city: Wien
country: Austria
facility: AKH - Medical University of Vienna
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: AZ Sint-Lucas - Campus Sint Lucas
city: Ieper
country: Belgium
facility: Ieper - HOSP Jan Yperman
city: Liège
country: Belgium
facility: Liège - HOSP CHR de la Citadelle
city: Lodelinsart
country: Belgium
facility: Charleroi - UNIV CHU de Charleroi
city: Roeselare
country: Belgium
facility: Roeselare - HOSP AZ Delta
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
city: Bremen
country: Germany
facility: Gesundheit Nord gGmbH | Klinikverbund Bremen
city: Düsseldorf
country: Germany
facility: Florence-Nightingale-Krankenhaus der Kaiserswerther Diakonie
city: Großhansdorf
country: Germany
facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
city: Kaiserslautern
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Löwenstein
country: Germany
facility: Klinik, Löwenstein
city: Münnerstadt
country: Germany
facility: Thoraxzentrum Bezirk Unterfranken
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Oldenburg
country: Germany
facility: Pius-Hospital, Oldenburg
city: Saarbrücken
country: Germany
facility: Caritas Klinik St. Theresia; Saarbrücken
city: Völklingen
country: Germany
facility: SHG-Kliniken Völklingen
city: Athens
country: Greece
facility: Athens Hospital of Chest Dis.
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Centre
city: Budapest
country: Hungary
facility: National Koranyi TBC and Pulm. Internal Med. Clinic
city: Matrahaza
country: Hungary
facility: Lung Hospital of Matra, Dept. Pulmonology
city: Miskolc
country: Hungary
facility: BAZ County Central Hospital and University Teaching Hospital
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos
city: Vilnius
country: Lithuania
facility: National Cancer Institute, Vilnius
city: Luxembourg
country: Luxembourg
facility: Luxembourg - HOSP CH de Luxembourg
city: Amsterdam
country: Netherlands
facility: OLVG, locatie Oosterpark
city: EDE
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Harderwijk
country: Netherlands
facility: Sint Jansdal Ziekenhuis
city: Hengelo
country: Netherlands
facility: Ziekenhuisgroep Twente locatie Hengelo
city: Hilversum
country: Netherlands
facility: Tergooi Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Buegos
country: Spain
facility: Hospital Universitario de Burgos
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular - Materno Infantil
city: Leganes - Madrid
country: Spain
facility: Hospital Severo Ochoa
city: León
country: Spain
facility: Hospital de León
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital La Paz
city: Mataró
country: Spain
facility: Hospital de Mataró
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Sabadell
country: Spain
facility: CS Parc Taulí
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa - Hospital de Terrassa
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Gävle
country: Sweden
facility: Gävle Sjukhus
city: Linköping
country: Sweden
facility: Universitetssjukhuset, Linköping
city: Stockholm
country: Sweden
facility: Karolinska Univ. sjukhuset
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Bebington, Wirral
country: United Kingdom
facility: Clatterbridge Cancer Centre
city: Bury St Edmunds
country: United Kingdom
facility: West Suffolk Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
city: Keighley
country: United Kingdom
facility: Airedale General Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: