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Nintedanib (BIBF 1120) in Mesothelioma

Primary Purpose

Mesothelioma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nintedanib
Pemetrexed
Cisplatin
Cisplatin
Pemetrexed
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Histologically confirmed malignant pleural mesothelioma (MPM) (Epithelioid or biphasic subtype for Phase II patients; epithelioid subtype only for Phase III patients)
  • Life expectancy of at least 3 months in the opinion of the investigator
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Measurable disease according to modified RECIST (Response Evaluation Criteria In Solid Tumours) criteria

Exclusion criteria:

  • Previous systemic chemotherapy for MPM
  • Prior treatment with nintedanib or any other prior line of therapy
  • Phase II patients with sarcomatoid subtype MPM or Phase III patients with biphasic or sarcomatoid subtype MPM
  • Patients with symptomatic neuropathy
  • Radiotherapy (except extremities) within 3 months prior to baseline imaging
  • Active brain metastases (e.g. stable for < 4 weeks)
  • Radiographic evidence of cavitary or necrotic tumours or local invasion of major blood vessels by MPM
  • Significant cardiovascular diseases
  • Inadequate hematologic, renal, or hepatic function

Sites / Locations

  • University of Alabama at Birmingham
  • University of California San Francisco
  • Rocky Mountain Cancer Centers
  • Comprehensive Cancer Centers of Nevada
  • University of Pittsburgh Medical Center
  • Greenville Health System
  • The University of Texas MD Anderson Cancer Center
  • Texas Oncology - McAllen
  • Texas Oncology-San Antonio Northeast
  • Cancer Care Northwest Centers, PS
  • Sanatorio Güemes
  • Instituto Medico Especializado Alexander Fleming
  • Clínica Universitaria Reina Fabiola
  • Northern Cancer Institute
  • Calvary Mater Newcastle Hospital
  • The Prince Charles Hospital
  • Mater Cancer Care Centre
  • Box Hill Hospital
  • Peninsula Haematology & Oncology
  • Austin Health
  • Border Onclogy Research
  • Sir Charles Gairdner Hospital
  • Perth Oncology
  • LKH Leoben
  • AKH - Medical University of Vienna
  • Klinikum Wels - Grieskirchen GmbH
  • Brussels - UNIV Saint-Luc
  • Edegem - UNIV UZ Antwerpen
  • UNIV UZ Gent
  • UZ Leuven
  • AZ Sint-Maarten
  • QEII Health Sciences Centre (Dalhousie University)
  • Health Sciences North
  • Princess Margaret Cancer Centre
  • IUCPQ (Laval University)
  • Centro Internacional de Estudios Clínicos - CIEC
  • Orlandi Oncologia
  • University Clinic for Pulmonary Diseases
  • University Hospital Brno
  • University Hospital Olomouc
  • Rigshospitalet, København, Onkologisk afdeling
  • Clinical Research Center Alexandria
  • Medical Research Institute
  • National Cancer Institute, Cairo University
  • Nasser Institute
  • CLI Bordeaux Nord Aquitaine
  • HOP Morvan
  • HOP Côte de Nacre
  • HOP Calmette
  • HOP Nord
  • HOP Lyon Sud
  • HOP HIA Saint-Anne
  • HOP Larrey
  • INS Gustave Roussy
  • Vivantes Netzwerk für Gesundheit GmbH
  • Helios Klinikum Emil von Behring
  • Klinik Schillerhöhe GmbH
  • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
  • Universitätsklinikum des Saarlandes
  • Klinik, Löwenstein
  • Rambam Medical Center
  • Rabin Medical Center Beilinson
  • Sourasky Medical Center
  • Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
  • Centro di riferimento Oncologico
  • Humanitas Gavazzeni
  • Istituto Nazionale per la Ricerca sul Cancro
  • Azienda Sanitaria Ospedale S. Luigi Gonzaga
  • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • University Hospital of Occupational and Environmental Health
  • Hyogo Prefectural Amagasaki General Medical Center
  • Hyogo College of Medicine Hospital
  • Yokosuka Kyosai Hospital
  • Japan Labour Health and Safety Organization Okayama Rosai Hospital
  • Kindai University Hospital
  • Otemae Hospital
  • Juntendo University Hospital
  • Centro Oncologico de Chihuahua
  • Instituto Nacional de Cancerologia
  • Centro Oncologico Estatal ISSEMYM
  • Medisch Spectrum Twente
  • Zuyderland Medisch Centrum
  • Erasmus Medisch Centrum
  • Oslo Universitetssykehus HF, Radiumhospitalet
  • St. Olavs Hospital, Universitetssykehuset i Trondheim
  • University Clinical Center, Gdansk
  • Clin.Hosp.Med.Univ.Marcinkowski in Poznan
  • Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland
  • Onco.Cent. - Instit. of Maria Sklodowskiej-Curie
  • Centro Hospitalar Lisboa Norte Hospital Pulido Valente
  • Hospital CUF Porto
  • St.Budg.Heal.Inst."Chelyabinsk Reg.Clin.Cen.Onc&Nucl.Med"
  • St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
  • FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
  • 1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
  • FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF
  • SBI HC-Rep.Clin.Onc.Disp.MoH.Rep.Bashkortostan
  • Wilgers Oncology Centre
  • Hospital Universitario de Cruces
  • Hospital Vall d'Hebron
  • Hospital Clínic de Barcelona
  • Hospital Universitario Donostia
  • Hospital Duran i Reynals
  • Hospital Ramón y Cajal
  • Hospital Virgen de la Victoria
  • Hospital Virgen del Rocío
  • Hospital Clínico de Valencia
  • Sahlgrenska US, Göteborg
  • Universitetssjukhuset, Linköping
  • Skånes universitetssjukhus, Lund
  • Karolinska Univ. sjukhuset
  • Akademiska sjukhuset
  • Eskisehir Osmangazi Üni. Sag. Uygulama ve Arastirma Has.
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
  • Dr.Suat Seren EAH
  • Western General Hospital
  • Beatson West of Scotland Cancer Centre
  • Leicester Royal Infirmary
  • Guy's Hospital
  • The Royal Marsden Hospital
  • The Royal Marsden Hospital
  • Wythenshawe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo + pemetrexed/cisplatin

Nintedanib 200mg + pemetrexed/cisplatin

Arm Description

Placebo controlled arm

Experimental arm

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
This outcome measure presents progression-free survival. Disease progression was defined according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occurred first. For patients with known date of progression (or death): PFS (days) = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS (days, censored) = date of last imaging showing no progression - date randomization + 1 day.

Secondary Outcome Measures

Overall Survival (OS)
Overall survival was defined as the duration of time from randomization to time of death. This is the key secondary endpoint of the trial.
Objective Response According to Modified RECIST- Investigator Assessment
Objective response (best overall tumour response of confirmed complete response [CR] or confirmed partial response [PR]). Complete Response: disappearance of all target lesions Partial Response: at least a 30 % decrease in the total tumour measurement of target lesions, taking as reference the baseline total tumour measurement. Percentage of Patients with confirmed objective response is presented. This endpoint was only evaluated for Phase III part.
Disease Control According to Modified RECIST- Investigator Assessment
Disease control (best overall response of confirmed CR or PR, or Stable Disease (SD) that lasted ≥36 days) according to modified RECIST. Percentage of Patients with Disease control is presented. This endpoint was only evaluated for Phase III part.

Full Information

First Posted
July 22, 2013
Last Updated
March 15, 2019
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01907100
Brief Title
Nintedanib (BIBF 1120) in Mesothelioma
Official Title
LUME-Meso: Double Blind, Randomised, Multicentre, Phase II/III Study of Nintedanib in Combination With Pemetrexed / Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination With Pemetrexed / Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients With Unresectable Malignant Pleural Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Study Start Date
September 19, 2013 (Actual)
Primary Completion Date
March 16, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
545 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo + pemetrexed/cisplatin
Arm Type
Placebo Comparator
Arm Description
Placebo controlled arm
Arm Title
Nintedanib 200mg + pemetrexed/cisplatin
Arm Type
Experimental
Arm Description
Experimental arm
Intervention Type
Drug
Intervention Name(s)
Nintedanib
Intervention Description
triple kinase inhibitor; 200mg starting dose
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
backbone chemo
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
backbone chemo
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
backbone chemo
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
backbone chemo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Nintedanib matching placebo
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
This outcome measure presents progression-free survival. Disease progression was defined according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occurred first. For patients with known date of progression (or death): PFS (days) = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS (days, censored) = date of last imaging showing no progression - date randomization + 1 day.
Time Frame
From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival was defined as the duration of time from randomization to time of death. This is the key secondary endpoint of the trial.
Time Frame
From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)
Title
Objective Response According to Modified RECIST- Investigator Assessment
Description
Objective response (best overall tumour response of confirmed complete response [CR] or confirmed partial response [PR]). Complete Response: disappearance of all target lesions Partial Response: at least a 30 % decrease in the total tumour measurement of target lesions, taking as reference the baseline total tumour measurement. Percentage of Patients with confirmed objective response is presented. This endpoint was only evaluated for Phase III part.
Time Frame
Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months
Title
Disease Control According to Modified RECIST- Investigator Assessment
Description
Disease control (best overall response of confirmed CR or PR, or Stable Disease (SD) that lasted ≥36 days) according to modified RECIST. Percentage of Patients with Disease control is presented. This endpoint was only evaluated for Phase III part.
Time Frame
Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Histologically confirmed malignant pleural mesothelioma (MPM) (Epithelioid or biphasic subtype for Phase II patients; epithelioid subtype only for Phase III patients) Life expectancy of at least 3 months in the opinion of the investigator Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Measurable disease according to modified RECIST (Response Evaluation Criteria In Solid Tumours) criteria Exclusion criteria: Previous systemic chemotherapy for MPM Prior treatment with nintedanib or any other prior line of therapy Phase II patients with sarcomatoid subtype MPM or Phase III patients with biphasic or sarcomatoid subtype MPM Patients with symptomatic neuropathy Radiotherapy (except extremities) within 3 months prior to baseline imaging Active brain metastases (e.g. stable for < 4 weeks) Radiographic evidence of cavitary or necrotic tumours or local invasion of major blood vessels by MPM Significant cardiovascular diseases Inadequate hematologic, renal, or hepatic function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120-4413
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology - McAllen
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Texas Oncology-San Antonio Northeast
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Cancer Care Northwest Centers, PS
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Sanatorio Güemes
City
Ciudad Autónoma de Bs As
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
Instituto Medico Especializado Alexander Fleming
City
Ciudad Autónoma de Bs As
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Clínica Universitaria Reina Fabiola
City
Ciudad de Cordoba
ZIP/Postal Code
X5004FHP
Country
Argentina
Facility Name
Northern Cancer Institute
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Calvary Mater Newcastle Hospital
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Mater Cancer Care Centre
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Peninsula Haematology & Oncology
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Border Onclogy Research
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Perth Oncology
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
LKH Leoben
City
Leoben
ZIP/Postal Code
8700
Country
Austria
Facility Name
AKH - Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Klinikum Wels - Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Brussels - UNIV Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Edegem - UNIV UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UNIV UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Sint-Maarten
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
QEII Health Sciences Centre (Dalhousie University)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Health Sciences North
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
IUCPQ (Laval University)
City
Quebec
ZIP/Postal Code
GLV 4G5
Country
Canada
Facility Name
Centro Internacional de Estudios Clínicos - CIEC
City
Recoleta
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Orlandi Oncologia
City
Vitacura
ZIP/Postal Code
7630372
Country
Chile
Facility Name
University Clinic for Pulmonary Diseases
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
University Hospital Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Rigshospitalet, København, Onkologisk afdeling
City
Købenahvn Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Clinical Research Center Alexandria
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Medical Research Institute
City
Alexandria
ZIP/Postal Code
21648
Country
Egypt
Facility Name
National Cancer Institute, Cairo University
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Facility Name
Nasser Institute
City
Cairo
ZIP/Postal Code
12655
Country
Egypt
Facility Name
CLI Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
HOP Morvan
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
HOP Côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
HOP Calmette
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
HOP Nord
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
HOP Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69230
Country
France
Facility Name
HOP HIA Saint-Anne
City
Toulon
ZIP/Postal Code
83800
Country
France
Facility Name
HOP Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
INS Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Vivantes Netzwerk für Gesundheit GmbH
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Helios Klinikum Emil von Behring
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Klinik Schillerhöhe GmbH
City
Gerlingen
ZIP/Postal Code
70839
Country
Germany
Facility Name
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Klinik, Löwenstein
City
Löwenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Rabin Medical Center Beilinson
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Facility Name
Centro di riferimento Oncologico
City
Aviano (PN)
ZIP/Postal Code
33081
Country
Italy
Facility Name
Humanitas Gavazzeni
City
Bergamo
ZIP/Postal Code
24125
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Sanitaria Ospedale S. Luigi Gonzaga
City
Orbassano (TO)
ZIP/Postal Code
10043
Country
Italy
Facility Name
A.O.U. Senese Policlinico Santa Maria alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
University Hospital of Occupational and Environmental Health
City
Fukuoka, Kitakyushu
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Hyogo Prefectural Amagasaki General Medical Center
City
Hyogo, Amagasaki
ZIP/Postal Code
660-8550
Country
Japan
Facility Name
Hyogo College of Medicine Hospital
City
Hyogo, Nishinomiya
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Yokosuka Kyosai Hospital
City
Kanagawa , Yokosuka
ZIP/Postal Code
238-8558
Country
Japan
Facility Name
Japan Labour Health and Safety Organization Okayama Rosai Hospital
City
Okayama, Okayama
ZIP/Postal Code
702-8055
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka, OsakaSayama
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Otemae Hospital
City
Osaka, Osaka
ZIP/Postal Code
540-0008
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo, Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Centro Oncologico de Chihuahua
City
Chihuahua
ZIP/Postal Code
31217
Country
Mexico
Facility Name
Instituto Nacional de Cancerologia
City
Mexico
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Centro Oncologico Estatal ISSEMYM
City
Toluca
ZIP/Postal Code
50180
Country
Mexico
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Oslo Universitetssykehus HF, Radiumhospitalet
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway
Facility Name
St. Olavs Hospital, Universitetssykehuset i Trondheim
City
Trondheim
ZIP/Postal Code
N-7006
Country
Norway
Facility Name
University Clinical Center, Gdansk
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Clin.Hosp.Med.Univ.Marcinkowski in Poznan
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Onco.Cent. - Instit. of Maria Sklodowskiej-Curie
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Facility Name
Hospital CUF Porto
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Facility Name
St.Budg.Heal.Inst."Chelyabinsk Reg.Clin.Cen.Onc&Nucl.Med"
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
SBI HC-Rep.Clin.Onc.Disp.MoH.Rep.Bashkortostan
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Wilgers Oncology Centre
City
Pretoria
ZIP/Postal Code
0041
Country
South Africa
Facility Name
Hospital Universitario de Cruces
City
Barakaldo (Vizcaya)
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Donostia
City
Donostia (Gipuzkoa)
ZIP/Postal Code
20080
Country
Spain
Facility Name
Hospital Duran i Reynals
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clínico de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Sahlgrenska US, Göteborg
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Universitetssjukhuset, Linköping
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Skånes universitetssjukhus, Lund
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Karolinska Univ. sjukhuset
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Akademiska sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Eskisehir Osmangazi Üni. Sag. Uygulama ve Arastirma Has.
City
Eskisehir
ZIP/Postal Code
26950
Country
Turkey
Facility Name
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Dr.Suat Seren EAH
City
Izmir
ZIP/Postal Code
35120
Country
Turkey
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
The Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
The Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Wythenshawe
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31103412
Citation
Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sorensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. doi: 10.1016/S2213-2600(19)30139-0. Epub 2019 May 15.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info

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Nintedanib (BIBF 1120) in Mesothelioma

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