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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2012-005201-48
Secondary ID [2] 0 0
1199.93
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mesothelioma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
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)
Secondary outcome [1] 0 0
Overall Survival (OS)
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)
Secondary outcome [2] 0 0
Objective Response According to Modified RECIST- Investigator Assessment
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
Secondary outcome [3] 0 0
Disease Control According to Modified RECIST- Investigator Assessment
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

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2018
Sample size
Target
Accrual to date
Final
545
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Northern Cancer Institute - St Leonards
Recruitment hospital [2] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [4] 0 0
Mater Cancer Care Centre - South Brisbane
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
Peninsula Haematology & Oncology - Frankston
Recruitment hospital [7] 0 0
Austin Health - Heidelberg
Recruitment hospital [8] 0 0
Border Onclogy Research - Wodonga
Recruitment hospital [9] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [10] 0 0
Perth Oncology - Perth
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3690 - Wodonga
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment postcode(s) [10] 0 0
6000 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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California
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Washington
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Argentina
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Ciudad Autónoma de Bs As
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Leoben
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Bruxelles
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Edegem
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Leuven
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Donostia (Gipuzkoa)
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L'Hospitalet de Llobregat
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Madrid
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Malaga
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Valencia
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Eskisehir
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Izmir
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Glasgow
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Leicester
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London
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Sutton
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United Kingdom
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Wythenshawe

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01907100
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01907100