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MesotheliomaPhase 2/3NCT01907100

Nintedanib (BIBF 1120) in Mesothelioma

A Phase 2/3 study testing Nintedanib, Pemetrexed and Cisplatin in people with Mesothelioma, run by Boehringer Ingelheim at 123 sites in 27 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mesothelioma
What is being tested?
Nintedanib, Pemetrexed and Cisplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
545 participants
Where
123 sitesin 27 countries
Study dates
19 Sep 2013to 31 Aug 2018
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

123 sites in 27 countries.

123 sites in 27 countries

United States10 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Greenville Health System

    Greenville, South Carolina, 29615

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Rocky Mountain Cancer Centers

    Littleton, Colorado, 80120-4413

  • Texas Oncology - McAllen

    McAllen, Texas, 78503

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Texas Oncology-San Antonio Northeast

    San Antonio, Texas, 78217

  • University of California San Francisco

    San Francisco, California, 94115

  • Cancer Care Northwest Centers, PS

    Spokane Valley, Washington, 99216

Other trials in United States

Australia10 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Peninsula Haematology & Oncology

    Frankston, Victoria, 3199

  • Austin Health

    Heidelberg, Victoria, 3084

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Perth Oncology

    Perth, Western Australia, 6000

  • Mater Cancer Care Centre

    South Brisbane, Queensland, 4101

  • Northern Cancer Institute

    St Leonards, New South Wales, 2065

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales, 2298

  • Border Onclogy Research

    Wodonga, Victoria, 3690

Other trials in Australia

France9 sites

  • CLI Bordeaux Nord Aquitaine

    Bordeaux, 33000

  • HOP Morvan

    Brest, 29609

  • HOP Côte de Nacre

    Caen, 14033

  • HOP Calmette

    Lille, 59000

  • HOP Nord

    Marseille, 13015

  • HOP Lyon Sud

    Pierre-Bénite, 69230

  • HOP HIA Saint-Anne

    Toulon, 83800

  • HOP Larrey

    Toulouse, 31059

  • INS Gustave Roussy

    Villejuif, 94805

Other trials in France

Spain9 sites

  • Hospital Universitario de Cruces

    Barakaldo (Vizcaya), 48903

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Donostia

    Donostia (Gipuzkoa), 20080

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08907

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Virgen del Rocío

    Seville, 41013

  • Hospital Clínico de Valencia

    Valencia, 46010

Other trials in Spain

Japan8 sites

  • University Hospital of Occupational and Environmental Health

    Fukuoka, Kitakyushu, 807-8556

  • Hyogo Prefectural Amagasaki General Medical Center

    Hyogo, Amagasaki, 660-8550

  • Hyogo College of Medicine Hospital

    Hyogo, Nishinomiya, 663-8501

  • Yokosuka Kyosai Hospital

    Kanagawa , Yokosuka, 238-8558

  • Japan Labour Health and Safety Organization Okayama Rosai Hospital

    Okayama, Okayama, 702-8055

  • Otemae Hospital

    Osaka, Osaka, 540-0008

  • Kindai University Hospital

    Osaka, OsakaSayama, 589-8511

  • Juntendo University Hospital

    Tokyo, Bunkyo-ku, 113-8431

Other trials in Japan

Germany7 sites

  • Vivantes Netzwerk für Gesundheit GmbH

    Berlin, 12351

  • Helios Klinikum Emil von Behring

    Berlin, 14165

  • Klinik Schillerhöhe GmbH

    Gerlingen, 70839

  • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927

  • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

    Heidelberg, 69126

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, 66421

  • Klinik, Löwenstein

    Löwenstein, 74245

Other trials in Germany

United Kingdom7 sites

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Guy's Hospital

    London, SE1 9RT

  • The Royal Marsden Hospital

    London, SW3 6JJ

  • The Royal Marsden Hospital

    Sutton, SM2 5PT

  • Wythenshawe Hospital

    Wythenshawe, M23 9LT

Other trials in United Kingdom

Italy6 sites

  • Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121

  • Centro di riferimento Oncologico

    Aviano (PN), 33081

  • Humanitas Gavazzeni

    Bergamo, 24125

  • Istituto Nazionale per la Ricerca sul Cancro

    Genova, 16132

  • Azienda Sanitaria Ospedale S. Luigi Gonzaga

    Orbassano (TO), 10043

  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    Siena, 53100

Other trials in Italy

Russia6 sites

  • St.Budg.Heal.Inst."Chelyabinsk Reg.Clin.Cen.Onc&Nucl.Med"

    Chelyabinsk, 454087

  • St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"

    Kazan', 420029

  • FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF

    Moscow, 115478

  • 1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.

    Saint Petersburg, 197022

  • FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF

    Saint Petersburg, 197758

  • SBI HC-Rep.Clin.Onc.Disp.MoH.Rep.Bashkortostan

    Ufa, 450054

Other trials in Russia

Belgium5 sites

  • Brussels - UNIV Saint-Luc

    Brussels, 1200

  • Edegem - UNIV UZ Antwerpen

    Edegem, 2650

  • UNIV UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • AZ Sint-Maarten

    Mechelen, 2800

Other trials in Belgium

Sweden5 sites

  • Sahlgrenska US, Göteborg

    Gothenburg, 413 45

  • Universitetssjukhuset, Linköping

    Linköping, 581 85

  • Skånes universitetssjukhus, Lund

    Lund, 221 85

  • Karolinska Univ. sjukhuset

    Stockholm, 171 76

  • Akademiska sjukhuset

    Uppsala, 751 85

Other trials in Sweden

Canada4 sites

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • QEII Health Sciences Centre (Dalhousie University)

    Halifax, Nova Scotia, B3H 1V7

  • IUCPQ (Laval University)

    Québec, GLV 4G5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Egypt4 sites

  • Clinical Research Center Alexandria

    Alexandria, 21131

  • Medical Research Institute

    Alexandria, 21648

  • National Cancer Institute, Cairo University

    Cairo, 11796

  • Nasser Institute

    Cairo, 12655

Other trials in Egypt

Poland4 sites

  • University Clinical Center, Gdansk

    Gdansk, 80-952

  • Clin.Hosp.Med.Univ.Marcinkowski in Poznan

    Poznan, 60-569

  • Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland

    Poznan, 60-569

  • Onco.Cent. - Instit. of Maria Sklodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

Argentina3 sites

  • Sanatorio Güemes

    Ciudad Autónoma de Bs As, C1180AAX

  • Instituto Medico Especializado Alexander Fleming

    Ciudad Autónoma de Bs As, C1426ANZ

  • Clínica Universitaria Reina Fabiola

    Córdoba, X5004FHP

Other trials in Argentina

Austria3 sites

  • LKH Leoben

    Leoben, 8700

  • AKH - Medical University of Vienna

    Vienna, 1090

  • Klinikum Wels - Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Israel3 sites

  • Rambam Medical Center

    Haifa, 31096

  • Rabin Medical Center Beilinson

    Petah Tikva, 49100

  • Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Mexico3 sites

  • Centro Oncologico de Chihuahua

    Chihuahua City, 31217

  • Instituto Nacional de Cancerologia

    México, 14080

  • Centro Oncologico Estatal ISSEMYM

    Toluca, 50180

Other trials in Mexico

Netherlands3 sites

  • Medisch Spectrum Twente

    Enschede, 7513 ER

  • Zuyderland Medisch Centrum

    Heerlen, 6419 PC

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CE

Other trials in Netherlands

Turkey (Türkiye)3 sites

  • Eskisehir Osmangazi Üni. Sag. Uygulama ve Arastirma Has.

    Eskişehir, 26950

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

    Istanbul, 34899

  • Dr.Suat Seren EAH

    Izmir, 35120

Other trials in Turkey (Türkiye)

Chile2 sites

  • Centro Internacional de Estudios Clínicos - CIEC

    Recoleta, 8420383

  • Orlandi Oncologia

    Vitacura, 7630372

Other trials in Chile

Czechia2 sites

  • University Hospital Brno

    Brno, 625 00

  • University Hospital Olomouc

    Olomouc, 779 00

Other trials in Czechia

Norway2 sites

  • Oslo Universitetssykehus HF, Radiumhospitalet

    Oslo, N-0310

  • St. Olavs Hospital, Universitetssykehuset i Trondheim

    Trondheim, N-7006

Other trials in Norway

Portugal2 sites

  • Centro Hospitalar Lisboa Norte Hospital Pulido Valente

    Lisbon, 1769-001

  • Hospital CUF Porto

    Porto, 4100-180

Other trials in Portugal

Croatia1 site

  • University Clinic for Pulmonary Diseases

    Zagreb, 10000

Other trials in Croatia

Denmark1 site

  • Rigshospitalet, København, Onkologisk afdeling

    Købenahvn Ø, 2100

Other trials in Denmark

South Africa1 site

  • Wilgers Oncology Centre

    Pretoria, 0041

Other trials in South Africa

About this study

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

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.

Conditions
Mesothelioma
Being tested
Nintedanib, Pemetrexed, Cisplatin, Placebo
Medical subject headings
Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NintedanibDrug

    triple kinase inhibitor; 200mg starting dose

  • PemetrexedDrug

    backbone chemo

  • CisplatinDrug

    backbone chemo

  • CisplatinDrug

    backbone chemo

  • PemetrexedDrug

    backbone chemo

  • PlaceboDrug

    Nintedanib matching placebo

Study groups in NCT01907100
Study groupRoleWhat they receive
Placebo + pemetrexed/cisplatinPlacebo comparatorPlacebo controlled arm
Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Placebo
Nintedanib 200mg + pemetrexed/cisplatinExperimentalExperimental arm
Receives: Drug: Nintedanib; Drug: Cisplatin; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    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.

    Measured: 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 (3)

  1. Overall Survival (OS)

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

    This is the key secondary endpoint of the trial.

    Measured: 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)

  2. Objective Response According to Modified RECIST- Investigator Assessment

    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.

    Measured: 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

  3. Disease Control According to Modified RECIST- Investigator Assessment

    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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2013 (estimated)
  2. Study start19 Sep 2013
  3. Primary completion16 Mar 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
545 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01907100
Sponsor's protocol ID
1199.93
Other IDs
2012-005201-48
Status last verified
Mar 2019
First submitted
22 Jul 2013
Last updated
18 Mar 2019

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.

    PubMed 31103412

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nintedanib, Pemetrexed and Cisplatin in people with Mesothelioma, run by Boehringer Ingelheim at 123 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, Australia, France, Spain, Japan and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01907100, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.

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