Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Nintedanib (BIBF 1120) in Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01907100
Recruitment Status : Terminated
First Posted : July 24, 2013
Results First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Mesothelioma Drug: Nintedanib Drug: Pemetrexed Drug: Cisplatin Drug: Placebo Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 545 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Actual Study Start Date : September 19, 2013
Actual Primary Completion Date : March 16, 2018
Actual Study Completion Date : August 31, 2018

Arm Intervention/treatment
Placebo Comparator: Placebo + pemetrexed/cisplatin
Placebo controlled arm
Drug: Pemetrexed
backbone chemo

Drug: Cisplatin
backbone chemo

Drug: Placebo
Nintedanib matching placebo

Experimental: Nintedanib 200mg + pemetrexed/cisplatin
Experimental arm
Drug: Nintedanib
triple kinase inhibitor; 200mg starting dose

Drug: Cisplatin
backbone chemo

Drug: Pemetrexed
backbone chemo

Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ 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) ]
    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 :
  1. Overall Survival (OS) [ 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) ]

    Overall survival was defined as the duration of time from randomization to time of death.

    This is the key secondary endpoint of the trial.

  2. Objective Response According to Modified RECIST- Investigator Assessment [ 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 ]

    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.

  3. Disease Control According to Modified RECIST- Investigator Assessment [ 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 ]

    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01907100

Hide Hide 123 study locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, California
University of California San Francisco
San Francisco, California, United States, 94115
United States, Colorado
Rocky Mountain Cancer Centers
Littleton, Colorado, United States, 80120-4413
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Greenville Health System
Greenville, South Carolina, United States, 29615
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Texas Oncology - McAllen
McAllen, Texas, United States, 78503
Texas Oncology-San Antonio Northeast
San Antonio, Texas, United States, 78217
United States, Washington
Cancer Care Northwest Centers, PS
Spokane Valley, Washington, United States, 99216
Sanatorio Güemes
Ciudad Autónoma de Bs As, Argentina, C1180AAX
Instituto Medico Especializado Alexander Fleming
Ciudad Autónoma de Bs As, Argentina, C1426ANZ
Clínica Universitaria Reina Fabiola
Ciudad de Cordoba, Argentina, X5004FHP
Australia, New South Wales
Northern Cancer Institute
St Leonards, New South Wales, Australia, 2065
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia, 2298
Australia, Queensland
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Mater Cancer Care Centre
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Peninsula Haematology & Oncology
Frankston, Victoria, Australia, 3199
Austin Health
Heidelberg, Victoria, Australia, 3084
Border Onclogy Research
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Perth Oncology
Perth, Western Australia, Australia, 6000
LKH Leoben
Leoben, Austria, 8700
AKH - Medical University of Vienna
Vienna, Austria, 1090
Klinikum Wels - Grieskirchen GmbH
Wels, Austria, 4600
Brussels - UNIV Saint-Luc
Bruxelles, Belgium, 1200
Edegem - UNIV UZ Antwerpen
Edegem, Belgium, 2650
Gent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
AZ Sint-Maarten
Mechelen, Belgium, 2800
Canada, Nova Scotia
QEII Health Sciences Centre (Dalhousie University)
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Health Sciences North
Sudbury, Ontario, Canada, P3E 5J1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
IUCPQ (Laval University)
Quebec, Canada, GLV 4G5
Centro Internacional de Estudios Clínicos - CIEC
Recoleta, Chile, 8420383
Orlandi Oncologia
Vitacura, Chile, 7630372
University Clinic for Pulmonary Diseases
Zagreb, Croatia, 10000
University Hospital Brno
Brno, Czechia, 625 00
University Hospital Olomouc
Olomouc, Czechia, 779 00
Rigshospitalet, København, Onkologisk afdeling
Købenahvn Ø, Denmark, 2100
Clinical Research Center Alexandria
Alexandria, Egypt, 21131
Medical Research Institute
Alexandria, Egypt, 21648
National Cancer Institute, Cairo University
Cairo, Egypt, 11796
Nasser Institute
Cairo, Egypt, 12655
CLI Bordeaux Nord Aquitaine
Bordeaux, France, 33000
HOP Morvan
Brest, France, 29609
HOP Côte de Nacre
Caen, France, 14033
HOP Calmette
Lille, France, 59000
HOP Nord
Marseille, France, 13015
HOP Lyon Sud
Pierre-Bénite, France, 69230
HOP HIA Saint-Anne
Toulon, France, 83800
HOP Larrey
Toulouse, France, 31059
INS Gustave Roussy
Villejuif, France, 94805
Vivantes Netzwerk für Gesundheit GmbH
Berlin, Germany, 12351
Helios Klinikum Emil von Behring
Berlin, Germany, 14165
Klinik Schillerhöhe GmbH
Gerlingen, Germany, 70839
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany, 22927
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, Germany, 69126
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany, 66421
Klinik, Löwenstein
Löwenstein, Germany, 74245
Rambam Medical Center
Haifa, Israel, 31096
Rabin Medical Center Beilinson
Petach Tikva, Israel, 49100
Sourasky Medical Center
Tel-Aviv, Israel, 64239
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy, 15121
Centro di riferimento Oncologico
Aviano (PN), Italy, 33081
Humanitas Gavazzeni
Bergamo, Italy, 24125
Istituto Nazionale per la Ricerca sul Cancro
Genova, Italy, 16132
Azienda Sanitaria Ospedale S. Luigi Gonzaga
Orbassano (TO), Italy, 10043
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, Italy, 53100
University Hospital of Occupational and Environmental Health
Fukuoka, Kitakyushu, Japan, 807-8556
Hyogo Prefectural Amagasaki General Medical Center
Hyogo, Amagasaki, Japan, 660-8550
Hyogo College of Medicine Hospital
Hyogo, Nishinomiya, Japan, 663-8501
Yokosuka Kyosai Hospital
Kanagawa , Yokosuka, Japan, 238-8558
Japan Labour Health and Safety Organization Okayama Rosai Hospital
Okayama, Okayama, Japan, 702-8055
Kindai University Hospital
Osaka, OsakaSayama, Japan, 589-8511
Otemae Hospital
Osaka, Osaka, Japan, 540-0008
Juntendo University Hospital
Tokyo, Bunkyo-ku, Japan, 113-8431
Centro Oncologico de Chihuahua
Chihuahua, Mexico, 31217
Instituto Nacional de Cancerologia
Mexico, Mexico, 14080
Centro Oncologico Estatal ISSEMYM
Toluca, Mexico, 50180
Medisch Spectrum Twente
Enschede, Netherlands, 7513 ER
Zuyderland Medisch Centrum
Heerlen, Netherlands, 6419 PC
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 CE
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, Norway, N-0310
St. Olavs Hospital, Universitetssykehuset i Trondheim
Trondheim, Norway, N-7006
University Clinical Center, Gdansk
Gdansk, Poland, 80-952
Clin.Hosp.Med.Univ.Marcinkowski in Poznan
Poznan, Poland, 60-569
Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland
Poznan, Poland, 60-569
Onco.Cent. - Instit. of Maria Sklodowskiej-Curie
Warsaw, Poland, 02-781
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
Lisboa, Portugal, 1769-001
Hospital CUF Porto
Porto, Portugal, 4100-180
Russian Federation
St.Budg.Heal.Inst."Chelyabinsk Reg.Clin.Cen.Onc&Nucl.Med"
Chelyabinsk, Russian Federation, 454087
St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
Kazan, Russian Federation, 420029
FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
Moscow, Russian Federation, 115478
1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
Saint-Petersburg, Russian Federation, 197022
FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF
Saint-Petersburg, Russian Federation, 197758
SBI HC-Rep.Clin.Onc.Disp.MoH.Rep.Bashkortostan
Ufa, Russian Federation, 450054
South Africa
Wilgers Oncology Centre
Pretoria, South Africa, 0041
Hospital Universitario de Cruces
Barakaldo (Vizcaya), Spain, 48903
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario Donostia
Donostia (Gipuzkoa), Spain, 20080
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain, 08907
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Virgen de la Victoria
Malaga, Spain, 29010
Hospital Virgen del Rocío
Sevilla, Spain, 41013
Hospital Clínico de Valencia
Valencia, Spain, 46010
Sahlgrenska US, Göteborg
Göteborg, Sweden, 413 45
Universitetssjukhuset, Linköping
Linköping, Sweden, 581 85
Skånes universitetssjukhus, Lund
Lund, Sweden, 221 85
Karolinska Univ. sjukhuset
Stockholm, Sweden, 171 76
Akademiska sjukhuset
Uppsala, Sweden, 751 85
Eskisehir Osmangazi Üni. Sag. Uygulama ve Arastirma Has.
Eskisehir, Turkey, 26950
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, Turkey, 34899
Dr.Suat Seren EAH
Izmir, Turkey, 35120
United Kingdom
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Guy's Hospital
London, United Kingdom, SE1 9RT
The Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
The Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Wythenshawe Hospital
Wythenshawe, United Kingdom, M23 9LT
Sponsors and Collaborators
Boehringer Ingelheim
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] June 22, 2016
Statistical Analysis Plan  [PDF] December 8, 2016

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boehringer Ingelheim Identifier: NCT01907100    
Other Study ID Numbers: 1199.93
2012-005201-48 ( EudraCT Number )
First Posted: July 24, 2013    Key Record Dates
Results First Posted: March 18, 2019
Last Update Posted: March 18, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Mesothelioma, Malignant
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors