LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer

NCT ID: NCT00805194

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-03
• Study Completion Date: 2017-11-13

Brief Summary

The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIBF 1120 plus docetaxel

BIBF 1120 2 times daily along with standard therapy of docetaxel

Group Type: EXPERIMENTAL

BIBF 1120 plus docetaxel

Intervention Type: DRUG

BIBF 1120 2 times daily along with standard therapy of docetaxel

Placebo plus docetaxel

Placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel

Group Type: PLACEBO_COMPARATOR

placebo plus docetaxel

Intervention Type: DRUG

placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel

Interventions

placebo plus docetaxel

placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel

Intervention Type: DRUG

BIBF 1120 plus docetaxel

BIBF 1120 2 times daily along with standard therapy of docetaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• male or female patient aged 18 years or older;
• histologically or cytologically confirmed, locally advanced and/or metastatic NSCLC of stage IIIB or IV or recurrent NSCLC;
• relapse or failure of one first line prior chemotherapy;
• at least one target tumour lesion that has not been irradiated within the past three months and that can accurately be measured ;
• life expectancy of at least three months;
• Eastern Cooperative Oncology group (ECOG) score of 0 or 1;
• patient has given written informed consent

Exclusion Criteria

• more than one prior chemotherapy regimen for advanced and/or metastatic or recurrent NSCLC;
• more than one chemotherapy treatment regimen (either neoadjuvant or adjuvant or neoadjuvant plus adjuvant) prior to first line chemotherapy;
• previous therapy with other VEGFR inhibitors (other than bevacizumab) or docetaxel for treatment of NSCLC;
• persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy;
• treatment with other investigational drugs or other anti-cancer therapy or treatment in another clinical trial within the past four weeks before start of - therapy or concomitantly with this trial ;
• radiotherapy (except extremities and brain) within the past three months prior to baseline imaging;
• active brain metastases or leptomeningeal disease;
• radiographic evidence of cavitary or necrotic tumours;
• centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels;
• history of clinically significant haemoptysis within the past 3 months;
• therapeutic anticoagulation (except low dose heparin) or antiplatelet therapy;
• history of major thrombotic or clinically relevant major bleeding event in the past 6 months;
• known inherited predisposition to bleeding or thrombosis;
• significant cardiovascular diseases ;
• inadequate safety laboratory parameters;
• significant weight loss (> 10 %) within the past 6 weeks;
• current peripheral neuropathy greater than CTCAE grade 2 except due to trauma;
• preexisting ascites and/or clinically significant pleural effusion;
• major injuries and/or surgery within the past ten days prior to randomisation with incomplete wound healing;
• serious infections requiring systemic antibiotic therapy;
• decompensated diabetes mellitus or other contraindication to high dose corticosteroid therapy;
• gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug;
• active or chronic hepatitis C and/or B infection;
• serious illness or concomitant non-oncological disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration;
• patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial and for at least twelve months after end of active therapy;
• pregnancy or breast feeding;
• psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule;
• patients unable to comply with the protocol;
• active alcohol or drug abuse;
• other malignancy within the past three years other than basal cell skin cancer, or carcinoma in situ of the cervix;
• any contraindications for therapy with docetaxel;
• history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80);
• hypersensitivity to BIBF 1120 and/or the excipients of the trial drugs;
• hypersensitivity to contrast media

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Brest Regional Clinical

Brest Region, , Belarus

Gomel Regional Clinical

Homyel, , Belarus

LKH-Univ. Hospital Graz

Graz, , Austria

KH St. Vinzenz, Zams, Int. Abtlg.

Kufstein, , Austria

AKH d. Stadt Linz, Pulmologie

Linz, , Austria

Bobruisk Inter-distict

Babruysk, , Belarus

Public Health Inst. Minsk City Clinical Oncology Dispensary

Minsk, , Belarus

Scientific Research Minsk

Minsk Region, , Belarus

Mogilov Regional Oncological Dispensary

Mogilev, , Belarus

Vitebsk Regional Clinical Oncology Dispensary

Vitebsk, , Belarus

Centre Hospitalier Universitaire de Liège

Liège, , Belgium

Liège - HOSP CHR de la Citadelle

Liège, , Belgium

Multiprofile Hospital for Active Treatment

Gabrovo, , Bulgaria

Univ.Multiprofile Hospital "Dr. Georgy Stranski" EAD, Pleven

Pleven, , Bulgaria

District Oncology Dispensary Plovdiv

Plovdiv, , Bulgaria

Interdistrict Oncology Dispensary, Ruse

Rousse, , Bulgaria

District Oncology Dispensary Shumen

Shumen, , Bulgaria

Specialized Hospital for Active Treatment in Oncolcogy

Sofia, , Bulgaria

307 Hospital of PLA

Beijing, , China

Jilin Province Cancer Hospital

Changchun, , China

First Hospital of Jilin University

Changchun, , China

West China Hospital

Chengdu, , China

Southwest Hospital

Chongqing, , China

First Affiliated Hospital of Dalian Medical University

Dalian, , China

The Second Affiliated Hospital of Dalian Medical University

Dalian, , China

Fujian Provincial Tumor Hospital

Fujian, , China

Sun Yat-Sen University Cancer Center

Guangzhou, , China

Guangdong General Hospital

Guangzhou, , China

Sir Run Run Shaw Hospital

Hangzhou, , China

Zhejiang Cancer Hospital

Hangzhou, , China

The Third Affiliated Hospital of Harbin Medical University

Harbin, , China

the 81th Hospital of PLA

Nanjing, , China

Jiangsu Cancer Hospital

Nanjing, , China

Shanghai Chest Hospital

Shanghai, , China

Fudan University Shanghai Cancer Center

Shanghai, , China

Shanghai Pulmonary Hospital

Shanghai, , China

Tongji Hospital, Tongji University

Wuhan, , China

Zhongshan Hospital Fudan University

Xuhui Area, Shanghai, , China

Clinical Hospital Centar Sestre Milosrdnice

Zagreb, , Croatia

UHC Zagreb

Zagreb, , Croatia

University Hospital Brno

Brno, , Czechia

St. Anna Hospital, 2nd Internal Department

Brno, , Czechia

District Hospital Liberec

Liberec, , Czechia

Institut onkologie a rehabilitace Na Plesi s.r.o.

Nová Ves pod Pleší, , Czechia

District Hospital Pribram, Oncology Centrum

Příbram, , Czechia

Herlev Hospital

Herlev, , Denmark

Odense Universitetshospital

Odense C, , Denmark

HOP Croix Rousse, Pneumo, Lyon

Lyon, , France

INS Paoli-Calmettes

Marseille, , France

HOP Lyon Sud

Pierre-Bénite, , France

CHU de Rouen - Hôpital de Bois Guillaume

Rouen, , France

HOP Nord Laënnec

Saint-Herblain, , France

Oncology Institute of the Loire

Saint-Priest-en-Jarez, , France

HOP Civil

Strasbourg, , France

Sainte Anne Training hospital for the armies

Toulon, , France

Amtel Hospital first Clinical LLC

Tbilisi, , Georgia

National Centre of Oncology

Tbilisi, , Georgia

Chemotherapy & Immunotherapy Clinic 'Medulla', Tbilisi

Tbilisi, , Georgia

Gemeinschaftspraxis Dr. Brudler / Dr. Heinrich, Augsburg

Augsburg, , Germany

Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

Universitätsklinikum Benjamin Franklin, Berlin

Berlin, , Germany

Helios Klinikum Emil von Behring

Berlin, , Germany

Evangelische Lungenklinik Berlin

Buch, , Germany

Gemeinschaftspraxis für Hämatologie und Onkologie, Köln

Cologne, , Germany

Universitätsklinikum Frankfurt

Frankfurt, , Germany

Krankenhaus Nordwest, Frankfurt

Frankfurt am Main, , Germany

Klinikum Frankfurt Höchst GmbH

Frankfurt am Main, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Asklepios Fachkliniken München-Gauting

Gauting, , Germany

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

Großhansdorf, , Germany

Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, , Germany

Allgemeines Krankenhaus Harburg, 21075 Hamburg

Hamburg, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Klinikum Kassel GmbH

Kassel, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Universitätsklinikum Leipzig

Leipzig, , Germany

POIS Leipzig GbR

Leipzig, , Germany

Klinik, Löwenstein

Löwenstein, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Lübeck, , Germany

Katholisches Klinikum St. Hildegardiskrankenhaus, Mainz

Mainz, , Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Universitätsklinik links der Isar, München, Ziemssenstr. 1

München, , Germany

Klinikum rechts der Isar der Technischen Universität München

München, , Germany

Städt. Krankenhaus, München-Bogenhausen

München, , Germany

Pius-Hospital, Oldenburg

Oldenburg, , Germany

Universitätsklinikum Tübingen

Tübingen, , Germany

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Wiesbaden, , Germany

Evangelisches Krankenhaus, Witten

Witten, , Germany

Athens Hospital of Chest Diseasea "SOTIRIA"

Athens, , Greece

University Hospital of Heraklion, University Pulmonology Cl

Heraklio, , Greece

Iaso General Hospital

Holargos, Athens, , Greece

Papageorgiou Hospital, 1st Cardiological Cl., Thessaloniki

Thessaloniki, , Greece

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, , Greece

Vedanta Institute of Medical Sciences

Ahmedabad, , India

KIDWAI memoraial Institute of oncology

Bangalore, , India

Rajalakshmi Multispeciality Hospital

Bangalore, , India

Jawaharlal Nehru Cancer Hospital & Research Centre

Bhopal, M.P., , India

Apollo Hospital

Chennai, , India

Birla Cancer Centre

Jaipur, , India

Bhagwan Mahaveer Cancer Hospital & Research Center, Jawahar

Jaipur, , India

SEAROC cancer center,S.K.soni Hospital

Jaipur, Rajasthan, , India

B. P .Poddar Hospital & Medical Research Ltd.

Kolkata, West Bengal, , India

Kasturba Medical College and Hospital

Mangalore, , India

Tata Memorial Centre

Mumbai, , India

Shatabdi Superspeciality Hospital

Nashik, , India

Sir Gangaram Hospital

New Delhi, , India

Indraprastha Apollo Hospitals

New Delhi, , India

Rajiv Gandhi Cancer Institute and Research Centre

New Delhi, , India

Jehangir Hospital Oncology Department

Pune, Maharahtra, , India

Regional Cancer Center

Trivandrum, Kerala, , India

City Cancer Centre, Cancer Hospital & Research

Vijayawada, , India

King George Hospital

Visakhapatnam, , India

E. Wolfson Medical Center, Holon 58100

Holon, , Israel

Hadassah Medical Center, Ein-Karem

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Sourasky Medical Center

Tel Aviv, , Israel

The Chaim Sheba Medical Center Tel Hashomer

Tel Litwinsky, , Israel

Assaf Harofe Medical Center

Ẕerifin, , Israel

Az. Ospedaliere Umberto I di Ancona

Ancona, , Italy

Centro di riferimento Oncologico

Aviano, , Italy

Policlinico S. Orsola Malpighi

Bologna, , Italy

Fond. Poliambulanza Istituto

Brescia, , Italy

Azienda Ospedaliera Careggi

Florence, , Italy

Ospedale Civile

Ivrea (TO), , Italy

Istituto Scientifico Romagnolo

Meldola, , Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Azienda Sanitaria Ospedale S. Luigi Gonzaga

Orbassano, , Italy

Fondazione Salvatore Maugeri

Pavia, , Italy

Ospedale S.Maria della Misericordia, AO di Perugia

Perugia, , Italy

Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos

Kaunas, , Lithuania

Siauliu ligonine, Siauliai

Šiauliai, , Lithuania

Vilniaus Universiteto

Vilnius, , Lithuania

Pulmonology Center in Bydgoszcz

Bydgoszcz, , Poland

Regional Complex Hospital

Elblag, , Poland

Institute of Tuberculosis & Pulmonology, III. Dept., Olsztyn

Olsztyn, , Poland

Mazowieckiego Centrum

Otwock, , Poland

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

Poznan, , Poland

Independent Public Hospital in Suwalki

Suwałki, , Poland

Specialist Hospital, Szczecin-Zdunowo

Szczecin, , Poland

Regional Specialist Hospital

Słupsk, , Poland

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

Warsaw, , Poland

IPO Porto Francisco Gentil, EPE

Coimbra, , Portugal

IPO Lisboa Francisco Gentil, EPE

Lisbon, , Portugal

CHLN, EPE - Hospital de Santa Maria

Lisbon, , Portugal

IPO Porto Francisco Gentil, EPE

Porto, , Portugal

Centro Hospitalar São João,EPE

Porto, , Portugal

CHS, EPE - Hospital de São Bernardo

Setúbal, , Portugal

Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, , Portugal

Baia Mare Emergency County Hospital

Baia Mare, , Romania

Spitalul Clinic Judetean de Urgenta Brasov

Brasov, , Romania

Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'

Bucharest, , Romania

Institutul Oncologic "Prof. Dr. Ion Chiricuta"

Cluj-Napoca, , Romania

County Hospital "Dr. Alex Simionescu"

Hunedoara, , Romania

Centrul de Oncologie Medicala

Iași, , Romania

Emergency Clinical County Hospital "Sf Spiridon", Iasi

Iași, , Romania

Onesti County Hospital

Onești, , Romania

Emergency County Hospital "Sf.loan cel Nou"

Suceava, , Romania

Oncomed SRL

Timișoara, , Romania

SBIH of Arkhangelsk reg. "Arkhangelsk Clin. Onc. Dispensary"

Arkhangelsk, , Russia

GLPU Cheliabinsky

Chelyabinsk, , Russia

GUZ Irkutsk Regional Oncology Dispensary

Irkutsk, , Russia

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

Kazan', , Russia

RBIH "Kursk regional clinical oncology dispensary"

Kursk, , Russia

GUZ Regional Oncology Dispensary, Magnitogorsk

Magnitogorsk, , Russia

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

Moscow, , Russia

SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary"

Pyatigorsk, , Russia

GUZ "Regional Clinical Oncology Dispensary"

Ryazan, , Russia

GUZ Leningradskaya Regional Clin. Hospital, St. Petersburg

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

SPb SBIH "City Clinical Oncological Dispensary"

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

GUZ "Oncological Dispesary #2"

Sochi, , Russia

GUZ Sverdlovsky Regional Oncology Dispensary

Yekaterinburg, , Russia

Faculty Hospital Trnava

Trnava, , Slovakia

GVI oncology Medi Clinic

Cape Town, , South Africa

Parklands Hospital

Durban, , South Africa

WCR CMJAH Clinical Trial Site

Johannesburg, , South Africa

Medical Oncology Centre of Rosebank

Johannesburg, , South Africa

Langenhoven Drive Oncology Centre

Port Elizabeth, , South Africa

Pretoria Academic Hospital

Pretoria, , South Africa

Wilgers oncology

Pretoria, , South Africa

Gachon University Gil Medical Center

Incheon, , South Korea

VHS Medical Center

Seoul, , South Korea

The Catholic University of Korea, Seoul St.Mary's Hospital

Seoul, , South Korea

Hospital Clínic de Barcelona

Barcelona, , Spain

Hospital Universitario de Elche

Elche, , Spain

Hospital Jerez de la Frontera

Jerez de La Frontera-Cádiz, , Spain

Hospital La Princesa

Madrid, , Spain

Hospital Quirónsalud Madrid

Pozuelo de Alarcón, , Spain

Fundación Instituto Valenciano de Oncologia

Valencia, , Spain

Servicio de Oncologia Radiotherapica

Valencia, , Spain

Hospital Arnau de Vilanova

Valencia, , Spain

Kantonsspital Aarau

Aarau, , Switzerland

Kantonsspital Baden AG

Baden, , Switzerland

Chernigiv Regional Oncology Centre

Chernihiv, , Ukraine

Bukovynsk State Medical University

Chernivtsi, , Ukraine

Chmelnytskyi Oblasnnyi Oncologichnyi Tsentr

Chmelnytskyi, , Ukraine

City Clinical Hospital #4, Dnipropetrovsk State Medical Academy

Dnipropetrovsk, , Ukraine

Donetsk Regional Antitumor Centre

Donetsk, , Ukraine

Kharkiv Medical Acadamy of Postgraduate education

Kharkiv, , Ukraine

Kryvorizskyi regional communal clinical oncology centre

Kryvyi Rig, , Ukraine

Odesa Regional Oncological Centre

Odesa, , Ukraine

Ternopil regional communal clinical oncology centre

Ternopil, , Ukraine

Uzhgorod National University, Oncology Centre

Uzhhorod, , Ukraine

Vinnytsia Regional Clinical Oncological Dispensary

Vinnytsia, , Ukraine

Royal Bournemouth and Christchurch Hospital

Bournemouth, , United Kingdom

Bristol Haematology & Onc. Ctr

Bristol, , United Kingdom

Broomfield Hospital

Chelmsford, , United Kingdom

Wythenshawe Hospital

Manchester, , United Kingdom

Poole Hospital

Poole, , United Kingdom

Countries

Austria; Belarus; Belgium; Bulgaria; China; Croatia; Czechia; Denmark; France; Georgia; Germany; Greece; India; Israel; Italy; Lithuania; Poland; Portugal; Romania; Russia; Slovakia; South Africa; South Korea; Spain; Switzerland; Ukraine; United Kingdom

References

Gottfried M, Bennouna J, Bondarenko I, Douillard JY, Heigener DF, Krzakowski M, Mellemgaard A, Novello S, Orlov S, Summers Y, von Pawel J, Stohr J, Kaiser R, Reck M. Efficacy and Safety of Nintedanib Plus Docetaxel in Patients with Advanced Lung Adenocarcinoma: Complementary and Exploratory Analyses of the Phase III LUME-Lung 1 Study. Target Oncol. 2017 Aug;12(4):475-485. doi: 10.1007/s11523-017-0517-2.

Reference Type: DERIVED

PMID: 28702806 (View on PubMed)

Reck M, Kaiser R, Mellemgaard A, Douillard JY, Orlov S, Krzakowski M, von Pawel J, Gottfried M, Bondarenko I, Liao M, Gann CN, Barrueco J, Gaschler-Markefski B, Novello S; LUME-Lung 1 Study Group. Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small-cell lung cancer (LUME-Lung 1): a phase 3, double-blind, randomised controlled trial. Lancet Oncol. 2014 Feb;15(2):143-55. doi: 10.1016/S1470-2045(13)70586-2. Epub 2014 Jan 9.

Reference Type: DERIVED

PMID: 24411639 (View on PubMed)

Other Identifiers

2007-004803-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1199.13

Identifier Type: -

Identifier Source: org_study_id