Clinical trial NCT01907100: 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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Mesothelioma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-07-24
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 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 outcomes:
measure: Overall Survival (OS)
timeFrame: 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)
measure: Objective Response According to Modified RECIST- Investigator Assessment
timeFrame: 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
measure: Disease Control According to Modified RECIST- Investigator Assessment
timeFrame: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: McAllen
country: United States
facility: Texas Oncology - McAllen
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology-San Antonio Northeast
state: Texas
city: Spokane Valley
country: United States
facility: Cancer Care Northwest Centers, PS
state: Washington
city: Ciudad Autónoma de Bs As
country: Argentina
facility: Sanatorio Güemes
city: Ciudad Autónoma de Bs As
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming
city: Ciudad de Cordoba
country: Argentina
facility: Clínica Universitaria Reina Fabiola
city: St Leonards
country: Australia
facility: Northern Cancer Institute
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Cancer Care Centre
state: Queensland
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Haematology & Oncology
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Wodonga
country: Australia
facility: Border Onclogy Research
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Perth
country: Australia
facility: Perth Oncology
state: Western Australia
city: Leoben
country: Austria
facility: LKH Leoben
city: Vienna
country: Austria
facility: AKH - Medical University of Vienna
city: Wels
country: Austria
facility: Klinikum Wels - Grieskirchen GmbH
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: Edegem
country: Belgium
facility: Edegem - UNIV UZ Antwerpen
city: Gent
country: Belgium
facility: UNIV UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
city: Halifax
country: Canada
facility: QEII Health Sciences Centre (Dalhousie University)
state: Nova Scotia
city: Sudbury
country: Canada
facility: Health Sciences North
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Quebec
country: Canada
facility: IUCPQ (Laval University)
city: Recoleta
country: Chile
facility: Centro Internacional de Estudios Clínicos - CIEC
city: Vitacura
country: Chile
facility: Orlandi Oncologia
city: Zagreb
country: Croatia
facility: University Clinic for Pulmonary Diseases
city: Brno
country: Czechia
facility: University Hospital Brno
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Købenahvn Ø
country: Denmark
facility: Rigshospitalet, København, Onkologisk afdeling
city: Alexandria
country: Egypt
facility: Clinical Research Center Alexandria
city: Alexandria
country: Egypt
facility: Medical Research Institute
city: Cairo
country: Egypt
facility: National Cancer Institute, Cairo University
city: Cairo
country: Egypt
facility: Nasser Institute
city: Bordeaux
country: France
facility: CLI Bordeaux Nord Aquitaine
city: Brest
country: France
facility: HOP Morvan
city: Caen
country: France
facility: HOP Côte de Nacre
city: Lille
country: France
facility: HOP Calmette
city: Marseille
country: France
facility: HOP Nord
city: Pierre-Bénite
country: France
facility: HOP Lyon Sud
city: Toulon
country: France
facility: HOP HIA Saint-Anne
city: Toulouse
country: France
facility: HOP Larrey
city: Villejuif
country: France
facility: INS Gustave Roussy
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring
city: Gerlingen
country: Germany
facility: Klinik Schillerhöhe GmbH
city: Großhansdorf
country: Germany
facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Löwenstein
country: Germany
facility: Klinik, Löwenstein
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center Beilinson
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
city: Aviano (PN)
country: Italy
facility: Centro di riferimento Oncologico
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni
city: Genova
country: Italy
facility: Istituto Nazionale per la Ricerca sul Cancro
city: Orbassano (TO)
country: Italy
facility: Azienda Sanitaria Ospedale S. Luigi Gonzaga
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria alle Scotte
city: Fukuoka, Kitakyushu
country: Japan
facility: University Hospital of Occupational and Environmental Health
city: Hyogo, Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center
city: Hyogo, Nishinomiya
country: Japan
facility: Hyogo College of Medicine Hospital
city: Kanagawa , Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital
city: Okayama, Okayama
country: Japan
facility: Japan Labour Health and Safety Organization Okayama Rosai Hospital
city: Osaka, OsakaSayama
country: Japan
facility: Kindai University Hospital
city: Osaka, Osaka
country: Japan
facility: Otemae Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
city: Chihuahua
country: Mexico
facility: Centro Oncologico de Chihuahua
city: Mexico
country: Mexico
facility: Instituto Nacional de Cancerologia
city: Toluca
country: Mexico
facility: Centro Oncologico Estatal ISSEMYM
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF, Radiumhospitalet
city: Trondheim
country: Norway
facility: St. Olavs Hospital, Universitetssykehuset i Trondheim
city: Gdansk
country: Poland
facility: University Clinical Center, Gdansk
city: Poznan
country: Poland
facility: Clin.Hosp.Med.Univ.Marcinkowski in Poznan
city: Poznan
country: Poland
facility: Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland
city: Warsaw
country: Poland
facility: Onco.Cent. - Instit. of Maria Sklodowskiej-Curie
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte Hospital Pulido Valente
city: Porto
country: Portugal
facility: Hospital CUF Porto
city: Chelyabinsk
country: Russian Federation
facility: St.Budg.Heal.Inst."Chelyabinsk Reg.Clin.Cen.Onc&Nucl.Med"
city: Kazan
country: Russian Federation
facility: St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
city: Moscow
country: Russian Federation
facility: FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
city: Saint-Petersburg
country: Russian Federation
facility: 1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
city: Saint-Petersburg
country: Russian Federation
facility: FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF
city: Ufa
country: Russian Federation
facility: SBI HC-Rep.Clin.Onc.Disp.MoH.Rep.Bashkortostan
city: Pretoria
country: South Africa
facility: Wilgers Oncology Centre
city: Barakaldo (Vizcaya)
country: Spain
facility: Hospital Universitario de Cruces
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Donostia (Gipuzkoa)
country: Spain
facility: Hospital Universitario Donostia
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Göteborg
country: Sweden
facility: Sahlgrenska US, Göteborg
city: Linköping
country: Sweden
facility: Universitetssjukhuset, Linköping
city: Lund
country: Sweden
facility: Skånes universitetssjukhus, Lund
city: Stockholm
country: Sweden
facility: Karolinska Univ. sjukhuset
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi Üni. Sag. Uygulama ve Arastirma Has.
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
city: Izmir
country: Turkey
facility: Dr.Suat Seren EAH
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital
city: Wythenshawe
country: United Kingdom
facility: Wythenshawe Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
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.