LUME BioNIS: a Biomarker Study in Patients With NSCLC

September 2, 2020 updated by: Boehringer Ingelheim

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.

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®.

Study Overview

Status

Completed

Conditions

Carcinoma, Non-Small-Cell Lung

Detailed Description

Purpose:

Study Type

Observational

Enrollment (Actual)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Krems, Austria, 3500
    - LK Krems
  - Wien, Austria, 1090
    - AKH - Medical University of Vienna
Belgium
- - Bruxelles, Belgium, 1200
    - Brussels - UNIV Saint-Luc
  - Gent, Belgium, 9000
    - AZ Maria Middelares
  - Gent, Belgium, 9000
    - AZ Sint-Lucas - Campus Sint Lucas
  - Ieper, Belgium, 8900
    - Ieper - HOSP Jan Yperman
  - Liège, Belgium, 4000
    - Liège - HOSP CHR de la Citadelle
  - Lodelinsart, Belgium, 6042
    - Charleroi - UNIV CHU de Charleroi
  - Roeselare, Belgium, 8800
    - Roeselare - HOSP AZ Delta
Denmark
- - Herlev, Denmark, 2730
    - Herlev and Gentofte Hospital
Germany
- - Bremen, Germany, 28325
    - Gesundheit Nord gGmbH | Klinikverbund Bremen
  - Düsseldorf, Germany, 40489
    - Florence-Nightingale-Krankenhaus der Kaiserswerther Diakonie
  - Großhansdorf, Germany, 22927
    - Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
  - Kaiserslautern, Germany, 67655
    - Onkologische Schwerpunktpraxis
  - Löwenstein, Germany, 74245
    - Klinik, Löwenstein
  - Münnerstadt, Germany, 97702
    - Thoraxzentrum Bezirk Unterfranken
  - Nürnberg, Germany, 90419
    - Klinikum Nürnberg
  - Oldenburg, Germany, 26121
    - Pius-Hospital, Oldenburg
  - Saarbrücken, Germany, 66113
    - Caritas Klinik St. Theresia; Saarbrücken
  - Völklingen, Germany, 66333
    - SHG-Kliniken Völklingen
Greece
- - Athens, Greece, 11527
    - Athens Hospital of Chest Dis.
  - Heraklion, Greece, 71110
    - University General Hospital of Heraklion
  - Thessaloniki, Greece, 555 35
    - European Interbalkan Medical Centre
Hungary
- - Budapest, Hungary, 1121
    - National Koranyi TBC and Pulm. Internal Med. Clinic
  - Matrahaza, Hungary, 3233
    - Lung Hospital of Matra, Dept. Pulmonology
  - Miskolc, Hungary, 3526
    - BAZ County Central Hospital and University Teaching Hospital
Italy
- - Alessandria, Italy, 15100
    - Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
  - Palermo, Italy, 90146
    - Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Lithuania
- - Kaunas, Lithuania, LT-50009
    - Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos
  - Vilnius, Lithuania, 08660
    - National Cancer Institute, Vilnius
Luxembourg
- - Luxembourg, Luxembourg, 1210
    - Luxembourg - HOSP CH de Luxembourg
Netherlands
- - Amsterdam, Netherlands, 1091 AC
    - OLVG, locatie Oosterpark
  - EDE, Netherlands, 6716 RP
    - Ziekenhuis Gelderse Vallei
  - Groningen, Netherlands, 9728 NT
    - Martini Ziekenhuis
  - Harderwijk, Netherlands, 3844 DG
    - Sint Jansdal Ziekenhuis
  - Hengelo, Netherlands, 7555DL
    - Ziekenhuisgroep Twente locatie Hengelo
  - Hilversum, Netherlands, 1213 XZ
    - Tergooi Ziekenhuis
  - Rotterdam, Netherlands, 3079 DZ
    - Maasstad ziekenhuis
Spain
- - Alicante, Spain, 03010
    - Hospital General Universitario de Alicante
  - Buegos, Spain, 09006
    - Hospital Universitario de Burgos
  - Girona, Spain, 17007
    - Hospital Universitari de Girona Doctor Josep Trueta
  - Jaén, Spain, 23007
    - Complejo Hospitalario de Jaén
  - Las Palmas de Gran Canaria, Spain, 35016
    - Complejo Hospitalario Universitario Insular - Materno Infantil
  - Leganes - Madrid, Spain, 28911
    - Hospital Severo Ochoa
  - León, Spain, 24008
    - Hospital de León
  - Lugo, Spain, 27003
    - Hospital Universitario Lucus Augusti
  - Madrid, Spain, 28040
    - Hospital Clinico San Carlos
  - Madrid, Spain, 28046
    - Hospital La Paz
  - Mataró, Spain, 08304
    - Hospital de Mataró
  - Palma de Mallorca, Spain, 07010
    - Hospital Son Espases
  - Pamplona, Spain, 31008
    - Complejo Hospitalario de Navarra
  - Sabadell, Spain, 08208
    - CS Parc Taulí
  - Santander, Spain, 39008
    - Hospital Universitario Marqués de Valdecilla
  - Sevilla, Spain, 41013
    - Hospital Virgen Del Rocio
  - Sevilla, Spain, 41071
    - Hospital Virgen Macarena
  - Terrassa, Spain, 08227
    - Consorci Sanitari de Terrassa - Hospital de Terrassa
  - Valencia, Spain, 46015
    - Hospital Arnau de Vilanova
  - Valladolid, Spain, 47005
    - Hospital Clínico Universitario de Valladolid
Sweden
- - Gävle, Sweden, 801 87
    - Gävle Sjukhus
  - Linköping, Sweden, 581 85
    - Universitetssjukhuset, Linköping
  - Stockholm, Sweden, 171 76
    - Karolinska Univ. sjukhuset
  - Uppsala, Sweden, 751 85
    - Akademiska Sjukhuset
United Kingdom
- - Aberdeen, United Kingdom, AB25 2ZN
    - Aberdeen Royal Infirmary
  - Bebington, Wirral, United Kingdom, CH63 4JY
    - Clatterbridge Cancer Centre
  - Bury St Edmunds, United Kingdom, IP33 2QZ
    - West Suffolk Hospital
  - Exeter, United Kingdom, EX2 5DW
    - Royal Devon and Exeter Hospital
  - Ipswich, United Kingdom, IP4 5PD
    - Ipswich Hospital
  - Keighley, United Kingdom, BD20 6TD
    - Airedale General Hospital
  - Middlesbrough, United Kingdom, TS4 3BW
    - James Cook University Hospital
  - Newcastle Upon Tyne, United Kingdom, NE7 7DN
    - Freeman Hospital
  - Plymouth, United Kingdom, PL6 8DH
    - Derriford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

NSCLC patients under Vargatef® treatment according to label

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Overall Survival (OS) Event Time Frame: 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.	From start of entering the study until death or last contact date, up to 42 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2016

Primary Completion (Actual)

September 3, 2019

Study Completion (Actual)

September 3, 2019

Study Registration Dates

First Submitted

January 29, 2016

First Submitted That Met QC Criteria