Carcinoma, Non-Small-Cell LungNCT02671422
LUME BioNIS: a Biomarker Study in Patients With NSCLC
An observational study of Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 71 sites in 13 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 260 participants
- Where
- 71 sitesin 13 countries
- Study dates
- 9 Mar 2016to 3 Sep 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NSCLC patients under Vargatef® treatment according to label
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
71 sites in 13 countries.
71 sites in 13 countries
Spain20 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitario de Burgos
Buegos, 09006
Hospital Universitari de Girona Doctor Josep Trueta
Girona, 17007
Complejo Hospitalario de Jaén
Jaén, 23007
Complejo Hospitalario Universitario Insular - Materno Infantil
Las Palmas de Gran Canaria, 35016
Hospital Severo Ochoa
Leganes - Madrid, 28911
Hospital de León
León, 24008
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital Clínico San Carlos
Madrid, 28040
Hospital La Paz
Madrid, 28046
Hospital de Mataró
Mataró, 08304
Hospital Son Espases
Palma de Mallorca, 07010
Complejo Hospitalario de Navarra
Pamplona, 31008
CS Parc Taulí
Sabadell, 08208
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Hospital Virgen del Rocío
Seville, 41013
Hospital Virgen Macarena
Seville, 41071
Consorci Sanitari de Terrassa - Hospital de Terrassa
Terrassa, 08227
Hospital Arnau de Vilanova
Valencia, 46015
Hospital Clínico Universitario de Valladolid
Valladolid, 47005
Germany10 sites
Gesundheit Nord gGmbH | Klinikverbund Bremen
Bremen, 28325
Florence-Nightingale-Krankenhaus der Kaiserswerther Diakonie
Düsseldorf, 40489
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
Onkologische Schwerpunktpraxis
Kaiserslautern, 67655
Klinik, Löwenstein
Löwenstein, 74245
Thoraxzentrum Bezirk Unterfranken
Münnerstadt, 97702
Klinikum Nürnberg
Nuremberg, 90419
Pius-Hospital, Oldenburg
Oldenburg, 26121
Caritas Klinik St. Theresia; Saarbrücken
Saarbrücken, 66113
SHG-Kliniken Völklingen
Völklingen, 66333
United Kingdom9 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Clatterbridge Cancer Centre
Bebington, Wirral, CH63 4JY
West Suffolk Hospital
Bury St Edmunds, IP33 2QZ
Royal Devon and Exeter Hospital
Exeter, EX2 5DW
Ipswich Hospital
Ipswich, IP4 5PD
Airedale General Hospital
Keighley, BD20 6TD
James Cook University Hospital
Middlesbrough, TS4 3BW
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Derriford Hospital
Plymouth, PL6 8DH
Belgium7 sites
Brussels - UNIV Saint-Luc
Brussels, 1200
AZ Maria Middelares
Ghent, 9000
AZ Sint-Lucas - Campus Sint Lucas
Ghent, 9000
Ieper - HOSP Jan Yperman
Ieper, 8900
Liège - HOSP CHR de la Citadelle
Liège, 4000
Charleroi - UNIV CHU de Charleroi
Lodelinsart, 6042
Roeselare - HOSP AZ Delta
Roeselare, 8800
Netherlands7 sites
OLVG, locatie Oosterpark
Amsterdam, 1091 AC
Ziekenhuis Gelderse Vallei
Ede, 6716 RP
Martini Ziekenhuis
Groningen, 9728 NT
Sint Jansdal Ziekenhuis
Harderwijk, 3844 DG
Ziekenhuisgroep Twente locatie Hengelo
Hengelo, 7555DL
Tergooi Ziekenhuis
Hilversum, 1213 XZ
Maasstad Ziekenhuis
Rotterdam, 3079 DZ
Sweden4 sites
Gävle Sjukhus
Gävle, 801 87
Universitetssjukhuset, Linköping
Linköping, 581 85
Karolinska Univ. sjukhuset
Stockholm, 171 76
Akademiska sjukhuset
Uppsala, 751 85
Greece3 sites
Athens Hospital of Chest Dis.
Athens, 11527
University General Hospital of Heraklion
Heraklion, 71110
European Interbalkan Medical Centre
Thessaloniki, 555 35
Hungary3 sites
National Koranyi TBC and Pulm. Internal Med. Clinic
Budapest, 1121
Lung Hospital of Matra, Dept. Pulmonology
Mátraháza, 3233
BAZ County Central Hospital and University Teaching Hospital
Miskolc, 3526
Austria2 sites
LK Krems
Krems, 3500
AKH - Medical University of Vienna
Vienna, 1090
Italy2 sites
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15100
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, 90146
Lithuania2 sites
Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos
Kaunas, LT-50009
National Cancer Institute, Vilnius
Vilnius, 08660
About this study
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.
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®.
Read the detailed description
Purpose:
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of entering the study until death or last contact date, up to 42 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study start9 Mar 2016
- Primary completion3 Sep 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671422
- Sponsor's protocol ID
- 1199.223
- Status last verified
- Sep 2020
- First submitted
- 29 Jan 2016
- Last updated
- 24 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02671422
- Acronym / sponsor ID
- 1199.223
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2016 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Posted 24 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC patients under Vargatef® treatment according to label
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
71 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 71 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in Spain, Germany, United Kingdom, Belgium, Netherlands and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.