Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01907100
Registration number
NCT01907100
Ethics application status
Date submitted
22/07/2013
Date registered
24/07/2013
Date last updated
18/03/2019
Titles & IDs
Public title
Nintedanib (BIBF 1120) in Mesothelioma
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2012-005201-48
Query!
Secondary ID [2]
0
0
1199.93
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Mesothelioma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Mesothelioma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Nintedanib
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Placebo
Placebo Comparator: Placebo + pemetrexed/cisplatin - Placebo controlled arm
Experimental: Nintedanib 200mg + pemetrexed/cisplatin - Experimental arm
Treatment: Drugs: Nintedanib
triple kinase inhibitor; 200mg starting dose
Treatment: Drugs: Pemetrexed
backbone chemo
Treatment: Drugs: Cisplatin
backbone chemo
Treatment: Drugs: Cisplatin
backbone chemo
Treatment: Drugs: Pemetrexed
backbone chemo
Treatment: Drugs: Placebo
Nintedanib matching placebo
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-Free Survival (PFS)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
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)
Query!
Secondary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
Overall survival was defined as the duration of time from randomization to time of death.
This is the key secondary endpoint of the trial.
Query!
Timepoint [1]
0
0
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)
Query!
Secondary outcome [2]
0
0
Objective Response According to Modified RECIST- Investigator Assessment
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
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
Query!
Secondary outcome [3]
0
0
Disease Control According to Modified RECIST- Investigator Assessment
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
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
Query!
Eligibility
Key inclusion 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2/Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
19/09/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
31/08/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
545
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Northern Cancer Institute - St Leonards
Query!
Recruitment hospital [2]
0
0
Calvary Mater Newcastle Hospital - Waratah
Query!
Recruitment hospital [3]
0
0
The Prince Charles Hospital - Chermside
Query!
Recruitment hospital [4]
0
0
Mater Cancer Care Centre - South Brisbane
Query!
Recruitment hospital [5]
0
0
Box Hill Hospital - Box Hill
Query!
Recruitment hospital [6]
0
0
Peninsula Haematology & Oncology - Frankston
Query!
Recruitment hospital [7]
0
0
Austin Health - Heidelberg
Query!
Recruitment hospital [8]
0
0
Border Onclogy Research - Wodonga
Query!
Recruitment hospital [9]
0
0
Sir Charles Gairdner Hospital - Nedlands
Query!
Recruitment hospital [10]
0
0
Perth Oncology - Perth
Query!
Recruitment postcode(s) [1]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [2]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [3]
0
0
4032 - Chermside
Query!
Recruitment postcode(s) [4]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [5]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [6]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [7]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [8]
0
0
3690 - Wodonga
Query!
Recruitment postcode(s) [9]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [10]
0
0
6000 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Nevada
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Pennsylvania
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
South Carolina
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Texas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Washington
Query!
Country [9]
0
0
Argentina
Query!
State/province [9]
0
0
Ciudad Autónoma de Bs As
Query!
Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
Ciudad de Cordoba
Query!
Country [11]
0
0
Austria
Query!
State/province [11]
0
0
Leoben
Query!
Country [12]
0
0
Austria
Query!
State/province [12]
0
0
Vienna
Query!
Country [13]
0
0
Austria
Query!
State/province [13]
0
0
Wels
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Bruxelles
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Edegem
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Gent
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Leuven
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Mechelen
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Nova Scotia
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Ontario
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Quebec
Query!
Country [22]
0
0
Chile
Query!
State/province [22]
0
0
Recoleta
Query!
Country [23]
0
0
Chile
Query!
State/province [23]
0
0
Vitacura
Query!
Country [24]
0
0
Croatia
Query!
State/province [24]
0
0
Zagreb
Query!
Country [25]
0
0
Czechia
Query!
State/province [25]
0
0
Brno
Query!
Country [26]
0
0
Czechia
Query!
State/province [26]
0
0
Olomouc
Query!
Country [27]
0
0
Denmark
Query!
State/province [27]
0
0
Købenahvn Ø
Query!
Country [28]
0
0
Egypt
Query!
State/province [28]
0
0
Alexandria
Query!
Country [29]
0
0
Egypt
Query!
State/province [29]
0
0
Cairo
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Bordeaux
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Brest
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Caen
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Lille
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Marseille
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Pierre-Bénite
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Toulon
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Toulouse
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Villejuif
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Berlin
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Gerlingen
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Großhansdorf
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Heidelberg
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Homburg/Saar
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Löwenstein
Query!
Country [45]
0
0
Israel
Query!
State/province [45]
0
0
Haifa
Query!
Country [46]
0
0
Israel
Query!
State/province [46]
0
0
Petach Tikva
Query!
Country [47]
0
0
Israel
Query!
State/province [47]
0
0
Tel-Aviv
Query!
Country [48]
0
0
Italy
Query!
State/province [48]
0
0
Alessandria
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Aviano (PN)
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Bergamo
Query!
Country [51]
0
0
Italy
Query!
State/province [51]
0
0
Genova
Query!
Country [52]
0
0
Italy
Query!
State/province [52]
0
0
Orbassano (TO)
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Siena
Query!
Country [54]
0
0
Japan
Query!
State/province [54]
0
0
Fukuoka, Kitakyushu
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Hyogo, Amagasaki
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Hyogo, Nishinomiya
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Kanagawa , Yokosuka
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Okayama, Okayama
Query!
Country [59]
0
0
Japan
Query!
State/province [59]
0
0
Osaka, OsakaSayama
Query!
Country [60]
0
0
Japan
Query!
State/province [60]
0
0
Osaka, Osaka
Query!
Country [61]
0
0
Japan
Query!
State/province [61]
0
0
Tokyo, Bunkyo-ku
Query!
Country [62]
0
0
Mexico
Query!
State/province [62]
0
0
Chihuahua
Query!
Country [63]
0
0
Mexico
Query!
State/province [63]
0
0
Mexico
Query!
Country [64]
0
0
Mexico
Query!
State/province [64]
0
0
Toluca
Query!
Country [65]
0
0
Netherlands
Query!
State/province [65]
0
0
Enschede
Query!
Country [66]
0
0
Netherlands
Query!
State/province [66]
0
0
Heerlen
Query!
Country [67]
0
0
Netherlands
Query!
State/province [67]
0
0
Rotterdam
Query!
Country [68]
0
0
Norway
Query!
State/province [68]
0
0
Oslo
Query!
Country [69]
0
0
Norway
Query!
State/province [69]
0
0
Trondheim
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Gdansk
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Poznan
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Warsaw
Query!
Country [73]
0
0
Portugal
Query!
State/province [73]
0
0
Lisboa
Query!
Country [74]
0
0
Portugal
Query!
State/province [74]
0
0
Porto
Query!
Country [75]
0
0
Russian Federation
Query!
State/province [75]
0
0
Chelyabinsk
Query!
Country [76]
0
0
Russian Federation
Query!
State/province [76]
0
0
Kazan
Query!
Country [77]
0
0
Russian Federation
Query!
State/province [77]
0
0
Moscow
Query!
Country [78]
0
0
Russian Federation
Query!
State/province [78]
0
0
Saint-Petersburg
Query!
Country [79]
0
0
Russian Federation
Query!
State/province [79]
0
0
Ufa
Query!
Country [80]
0
0
South Africa
Query!
State/province [80]
0
0
Pretoria
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Barakaldo (Vizcaya)
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Barcelona
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Donostia (Gipuzkoa)
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
L'Hospitalet de Llobregat
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
Madrid
Query!
Country [86]
0
0
Spain
Query!
State/province [86]
0
0
Malaga
Query!
Country [87]
0
0
Spain
Query!
State/province [87]
0
0
Sevilla
Query!
Country [88]
0
0
Spain
Query!
State/province [88]
0
0
Valencia
Query!
Country [89]
0
0
Sweden
Query!
State/province [89]
0
0
Göteborg
Query!
Country [90]
0
0
Sweden
Query!
State/province [90]
0
0
Linköping
Query!
Country [91]
0
0
Sweden
Query!
State/province [91]
0
0
Lund
Query!
Country [92]
0
0
Sweden
Query!
State/province [92]
0
0
Stockholm
Query!
Country [93]
0
0
Sweden
Query!
State/province [93]
0
0
Uppsala
Query!
Country [94]
0
0
Turkey
Query!
State/province [94]
0
0
Eskisehir
Query!
Country [95]
0
0
Turkey
Query!
State/province [95]
0
0
Istanbul
Query!
Country [96]
0
0
Turkey
Query!
State/province [96]
0
0
Izmir
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
Edinburgh
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
Glasgow
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Leicester
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
London
Query!
Country [101]
0
0
United Kingdom
Query!
State/province [101]
0
0
Sutton
Query!
Country [102]
0
0
United Kingdom
Query!
State/province [102]
0
0
Wythenshawe
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01907100
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
Query!
Address
0
0
Boehringer Ingelheim
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01907100
Download to PDF