Nintedanib (BIBF 1120) in Mesothelioma

March 15, 2019 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

545

Phase

  • Phase 2
  • Phase 3

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

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

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

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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: Pemetrexed
backbone chemo
Drug: Cisplatin
backbone chemo
Drug: Nintedanib
triple kinase inhibitor; 200mg starting dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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 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.
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

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.

General Publications

Helpful Links

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)

September 19, 2013

Primary Completion (ACTUAL)

March 16, 2018

Study Completion (ACTUAL)

August 31, 2018

Study Registration Dates

First Submitted

July 22, 2013

First Submitted That Met QC Criteria

July 22, 2013

First Posted (ESTIMATE)

July 24, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 15, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1199.93
  • 2012-005201-48 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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