LUME BioNIS: a Biomarker Study in Patients With NSCLC

NCT ID: NCT02671422

Last Updated: 2020-09-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-09
• Study Completion Date: 2019-09-03

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:

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

LK Krems

Krems, , Austria

AKH - Medical University of Vienna

Vienna, , Austria

Brussels - UNIV Saint-Luc

Brussels, , Belgium

AZ Maria Middelares

Ghent, , Belgium

AZ Sint-Lucas - Campus Sint Lucas

Ghent, , 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, , Belgium

Herlev and Gentofte Hospital

Herlev, , Denmark

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

Nuremberg, , Germany

Pius-Hospital, Oldenburg

Oldenburg, , Germany

Caritas Klinik St. Theresia; Saarbrücken

Saarbrücken, , Germany

SHG-Kliniken Völklingen

Völklingen, , Germany

Athens Hospital of Chest Dis.

Athens, , Greece

University General Hospital of Heraklion

Heraklion, , Greece

European Interbalkan Medical Centre

Thessaloniki, , Greece

National Koranyi TBC and Pulm. Internal Med. Clinic

Budapest, , Hungary

Lung Hospital of Matra, Dept. Pulmonology

Mátraháza, , Hungary

BAZ County Central Hospital and University Teaching Hospital

Miskolc, , Hungary

Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

Alessandria, , Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

Palermo, , Italy

Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos

Kaunas, , Lithuania

National Cancer Institute, Vilnius

Vilnius, , Lithuania

Luxembourg - HOSP CH de Luxembourg

Luxembourg, , Luxembourg

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, , Netherlands

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

Seville, , Spain

Hospital Virgen Macarena

Seville, , Spain

Consorci Sanitari de Terrassa - Hospital de Terrassa

Terrassa, , Spain

Hospital Arnau de Vilanova

Valencia, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Gävle Sjukhus

Gävle, , Sweden

Universitetssjukhuset, Linköping

Linköping, , Sweden

Karolinska Univ. sjukhuset

Stockholm, , Sweden

Akademiska sjukhuset

Uppsala, , Sweden

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, , United Kingdom

Countries

Austria; Belgium; Denmark; Germany; Greece; Hungary; Italy; Lithuania; Luxembourg; Netherlands; Spain; Sweden; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1199.223

Identifier Type: -

Identifier Source: org_study_id