AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3NCT00805194

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

A Phase 3 study testing BIBF 1120 plus docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 210 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
BIBF 1120 plus docetaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,314 participants
Where
210 sitesin 27 countries
Study dates
3 Dec 2008to 13 Nov 2017
Phase
Phase 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

  • 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

Who cannot join

  • 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;
Show all 34Show fewer
  • 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

Trial locations and contacts

210 sites in 27 countries.

210 sites in 27 countries

Germany30 sites

  • Gemeinschaftspraxis Dr. Brudler / Dr. Heinrich, Augsburg

    Augsburg, 86150

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437

  • Universitätsklinikum Benjamin Franklin, Berlin

    Berlin, 12200

  • Helios Klinikum Emil von Behring

    Berlin, 14165

  • Evangelische Lungenklinik Berlin

    Buch, 13125

  • Gemeinschaftspraxis für Hämatologie und Onkologie, Köln

    Cologne, 50677

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590

  • Krankenhaus Nordwest, Frankfurt

    Frankfurt am Main, 60488

  • Klinikum Frankfurt Höchst GmbH

    Frankfurt am Main, 65929

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Asklepios Fachkliniken München-Gauting

    Gauting, 82131

  • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927

  • Krankenhaus Martha-Maria Halle-Dölau gGmbH

    Halle, 06120

  • Allgemeines Krankenhaus Harburg, 21075 Hamburg

    Hamburg, 21075

  • Universitätsklinikum Heidelberg

    Heidelberg, 69126

  • Klinikum Kassel GmbH

    Kassel, 34125

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24116

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • POIS Leipzig GbR

    Leipzig, 04357

  • Klinik, Löwenstein

    Löwenstein, 74245

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Lübeck, 23538

  • Katholisches Klinikum St. Hildegardiskrankenhaus, Mainz

    Mainz, 55131

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, D-55131

  • Universitätsklinik links der Isar, München, Ziemssenstr. 1

    München, 80336

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Städt. Krankenhaus, München-Bogenhausen

    München, 81925

  • Pius-Hospital, Oldenburg

    Oldenburg, 26121

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Helios Dr. Horst Schmidt Kliniken Wiesbaden

    Wiesbaden, 65199

  • Evangelisches Krankenhaus, Witten

    Witten, 58455

Other trials in Germany

China20 sites

  • 307 Hospital of PLA

    Beijing, 100071

  • Jilin Province Cancer Hospital

    Changchun, 130012

  • First Hospital of Jilin University

    Changchun, 130021

  • West China Hospital

    Chengdu, 610041

  • Southwest Hospital

    Chongqing, 400038

  • First Affiliated Hospital of Dalian Medical University

    Dalian, 116011

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, 116027

  • Fujian Provincial Tumor Hospital

    Fujian, 350014

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060

  • Guangdong General Hospital

    Guangzhou, 510080

  • Sir Run Run Shaw Hospital

    Hangzhou, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • The Third Affiliated Hospital of Harbin Medical University

    Harbin, 150081

  • the 81th Hospital of PLA

    Nanjing, 210002

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • Shanghai Chest Hospital

    Shanghai, 200030

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • Tongji Hospital, Tongji University

    Wuhan, 430030

  • Zhongshan Hospital Fudan University

    Xuhui Area, Shanghai, 200032

Other trials in China

India19 sites

  • Vedanta Institute of Medical Sciences

    Ahmedabad, 380009

  • KIDWAI memoraial Institute of oncology

    Bangalore, 560029

  • Rajalakshmi Multispeciality Hospital

    Bangalore, 560078

  • Jawaharlal Nehru Cancer Hospital & Research Centre

    Bhopal, M.P., 462001

  • Apollo Hospital

    Chennai, 600035

  • Birla Cancer Centre

    Jaipur, 302004

  • Bhagwan Mahaveer Cancer Hospital & Research Center, Jawahar

    Jaipur, 302017

  • SEAROC cancer center,S.K.soni Hospital

    Jaipur, Rajasthan, 302013

  • B. P .Poddar Hospital & Medical Research Ltd.

    Kolkata, West Bengal, 700053

  • Kasturba Medical College and Hospital

    Mangalore, 575001

  • Tata Memorial Centre

    Mumbai, 400012

  • Shatabdi Superspeciality Hospital

    Nashik, 422005

  • Sir Gangaram Hospital

    New Delhi, 110060

  • Indraprastha Apollo Hospitals

    New Delhi, 110076

  • Rajiv Gandhi Cancer Institute and Research Centre

    New Delhi, 110085

  • Jehangir Hospital Oncology Department

    Pune, Maharahtra, 411001

  • Regional Cancer Center

    Trivandrum, Kerala, 695011

  • City Cancer Centre, Cancer Hospital & Research

    Vijayawada, 520002

  • King George Hospital

    Visakhapatnam, 530002

Other trials in India

Russia15 sites

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

    Arkhangelsk, 163045

  • GLPU Cheliabinsky

    Chelyabinsk, 454076

  • GUZ Irkutsk Regional Oncology Dispensary

    Irkutsk, 664035

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

    Kazan', 420029

  • RBIH "Kursk regional clinical oncology dispensary"

    Kursk, 305035

  • GUZ Regional Oncology Dispensary, Magnitogorsk

    Magnitogorsk, 455001

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

    Moscow, 115478

  • SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary"

    Pyatigorsk, 357502

  • GUZ "Regional Clinical Oncology Dispensary"

    Ryazan, 390011

  • GUZ Leningradskaya Regional Clin. Hospital, St. Petersburg

    Saint Petersburg, 194291

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

    Saint Petersburg, 197022

  • SPb SBIH "City Clinical Oncological Dispensary"

    Saint Petersburg, 197022

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

    Saint Petersburg, 197758

  • GUZ "Oncological Dispesary #2"

    Sochi, 354057

  • GUZ Sverdlovsky Regional Oncology Dispensary

    Yekaterinburg, 620036

Other trials in Russia

Italy11 sites

  • Az. Ospedaliere Umberto I di Ancona

    Ancona, 60020

  • Centro di riferimento Oncologico

    Aviano, 33081

  • Policlinico S. Orsola Malpighi

    Bologna, 40135

  • Fond. Poliambulanza Istituto

    Brescia, 25124

  • Azienda Ospedaliera Careggi

    Florence, 50139

  • Ospedale Civile

    Ivrea (TO), 10015

  • Istituto Scientifico Romagnolo

    Meldola, 47014

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Azienda Sanitaria Ospedale S. Luigi Gonzaga

    Orbassano, 10043

  • Fondazione Salvatore Maugeri

    Pavia, 27100

  • Ospedale S.Maria della Misericordia, AO di Perugia

    Perugia, 06132

Other trials in Italy

Ukraine11 sites

  • Chernigiv Regional Oncology Centre

    Chernihiv, 14029

  • Bukovynsk State Medical University

    Chernivtsi, 58013

  • Chmelnytskyi Oblasnnyi Oncologichnyi Tsentr

    Chmelnytskyi, 29000

  • City Clinical Hospital #4, Dnipropetrovsk State Medical Academy

    Dnipropetrovsk, 49102

  • Donetsk Regional Antitumor Centre

    Donetsk, 83000

  • Kharkiv Medical Acadamy of Postgraduate education

    Kharkiv, 61070

  • Kryvorizskyi regional communal clinical oncology centre

    Kryvyi Rig, 50048

  • Odesa Regional Oncological Centre

    Odesa, 65055

  • Ternopil regional communal clinical oncology centre

    Ternopil, 46023

  • Uzhgorod National University, Oncology Centre

    Uzhhorod, 88000

  • Vinnytsia Regional Clinical Oncological Dispensary

    Vinnytsia, 21029

Other trials in Ukraine

Romania10 sites

  • Baia Mare Emergency County Hospital

    Baia Mare, 430031

  • Spitalul Clinic Judetean de Urgenta Brasov

    Brasov, 500117

  • Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'

    Bucharest, 022328

  • Institutul Oncologic "Prof. Dr. Ion Chiricuta"

    Cluj-Napoca, 400015

  • County Hospital "Dr. Alex Simionescu"

    Hunedoara, 331057

  • Centrul de Oncologie Medicala

    Iași, 700106

  • Emergency Clinical County Hospital "Sf Spiridon", Iasi

    Iași, 700111

  • Onesti County Hospital

    Onești, 601048

  • Emergency County Hospital "Sf.loan cel Nou"

    Suceava, 720237

  • Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Poland9 sites

  • Pulmonology Center in Bydgoszcz

    Bydgoszcz, 85-326

  • Regional Complex Hospital

    Elblag, 82-300

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

    Olsztyn, 10-357

  • Mazowieckiego Centrum

    Otwock, 05-400

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

    Poznan, 60-569

  • Regional Specialist Hospital

    Słupsk, 76-200

  • Independent Public Hospital in Suwalki

    Suwałki, 16-400

  • Specialist Hospital, Szczecin-Zdunowo

    Szczecin, 70-891

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

    Warsaw, 02-781

Other trials in Poland

France8 sites

  • HOP Croix Rousse, Pneumo, Lyon

    Lyon, 69317

  • INS Paoli-Calmettes

    Marseille, 13273

  • HOP Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Rouen - Hôpital de Bois Guillaume

    Rouen, 76031

  • HOP Nord Laënnec

    Saint-Herblain, 44805

  • Oncology Institute of the Loire

    Saint-Priest-en-Jarez, 42271

  • HOP Civil

    Strasbourg, 67091

  • Sainte Anne Training hospital for the armies

    Toulon, 83401

Other trials in France

Spain8 sites

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitario de Elche

    Elche, 03202

  • Hospital Jerez de la Frontera

    Jerez de La Frontera-Cádiz, 11407

  • Hospital La Princesa

    Madrid, 28006

  • Hospital Quirónsalud Madrid

    Pozuelo de Alarcón, 28233

  • Fundación Instituto Valenciano de Oncologia

    Valencia, 46009

  • Servicio de Oncologia Radiotherapica

    Valencia, 46010

  • Hospital Arnau de Vilanova

    Valencia, 46015

Other trials in Spain

Belarus7 sites

  • Bobruisk Inter-distict

    Babruysk, 213825

  • Brest Regional Clinical

    Brest Region, 224027

  • Gomel Regional Clinical

    Homyel, 246012

  • Public Health Inst. Minsk City Clinical Oncology Dispensary

    Minsk, 220013

  • Scientific Research Minsk

    Minsk Region, 223040

  • Mogilov Regional Oncological Dispensary

    Mogilev, 212018

  • Vitebsk Regional Clinical Oncology Dispensary

    Vitebsk, 210603

Other trials in Belarus

Portugal7 sites

  • IPO Porto Francisco Gentil, EPE

    Coimbra, 3041-801

  • IPO Lisboa Francisco Gentil, EPE

    Lisbon, 1099-023

  • CHLN, EPE - Hospital de Santa Maria

    Lisbon, 1649-035

  • IPO Porto Francisco Gentil, EPE

    Porto, 4200-072

  • Centro Hospitalar São João,EPE

    Porto, 4200-319

  • CHS, EPE - Hospital de São Bernardo

    Setúbal, 2910

  • Centro Hospitalar de Vila Nova de Gaia

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

South Africa7 sites

  • GVI oncology Medi Clinic

    Cape Town, 7570

  • Parklands Hospital

    Durban, 4091

  • WCR CMJAH Clinical Trial Site

    Johannesburg, 2193

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2196

  • Langenhoven Drive Oncology Centre

    Port Elizabeth, 6045

  • Pretoria Academic Hospital

    Pretoria, 0001

  • Wilgers oncology

    Pretoria, 0041

Other trials in South Africa

Bulgaria6 sites

  • Multiprofile Hospital for Active Treatment

    Gabrovo, 5300

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

    Pleven, 5800

  • District Oncology Dispensary Plovdiv

    Plovdiv, 4004

  • Interdistrict Oncology Dispensary, Ruse

    Rousse, 7002

  • District Oncology Dispensary Shumen

    Shumen, 9700

  • Specialized Hospital for Active Treatment in Oncolcogy

    Sofia, 1756

Other trials in Bulgaria

Israel6 sites

  • E. Wolfson Medical Center, Holon 58100

    Holon, 58100

  • Hadassah Medical Center, Ein-Karem

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 44281

  • Sourasky Medical Center

    Tel Aviv, 64239

  • The Chaim Sheba Medical Center Tel Hashomer

    Tel HaShomer, 52621

  • Assaf Harofe Medical Center

    Tsrifin, 70300

Other trials in Israel

Czechia5 sites

  • University Hospital Brno

    Brno, 625 00

  • St. Anna Hospital, 2nd Internal Department

    Brno, 656 53

  • District Hospital Liberec

    Liberec, 460 01

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

    Nová Ves pod Pleší, 262 04

  • District Hospital Pribram, Oncology Centrum

    Příbram, 261 95

Other trials in Czechia

Greece5 sites

  • Athens Hospital of Chest Diseasea "SOTIRIA"

    Athens, 11527

  • University Hospital of Heraklion, University Pulmonology Cl

    Heraklio, 71110

  • Iaso General Hospital

    Holargos, Athens, 15562

  • Papageorgiou Hospital, 1st Cardiological Cl., Thessaloniki

    Thessaloniki, 54603

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki, 57010

Other trials in Greece

United Kingdom5 sites

  • Royal Bournemouth and Christchurch Hospital

    Bournemouth, BH7 7DW

  • Bristol Haematology & Onc. Ctr

    Bristol, BS28ED

  • Broomfield Hospital

    Chelmsford, CM1 7ET

  • Wythenshawe Hospital

    Manchester, M23 9LT

  • Poole Hospital

    Poole, BH15 2JB

Other trials in United Kingdom

Austria3 sites

  • LKH-Univ. Hospital Graz

    Graz, 8036

  • KH St. Vinzenz, Zams, Int. Abtlg.

    Kufstein, 6330

  • AKH d. Stadt Linz, Pulmologie

    Linz, 4020

Other trials in Austria

Georgia3 sites

  • Amtel Hospital first Clinical LLC

    Tbilisi, 0079

  • National Centre of Oncology

    Tbilisi, 0177

  • Chemotherapy & Immunotherapy Clinic 'Medulla', Tbilisi

    Tbilisi, 0186

Other trials in Georgia

Lithuania3 sites

  • Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos

    Kaunas, LT-50009

  • Siauliu ligonine, Siauliai

    Šiauliai, 76307

  • Vilniaus Universiteto

    Vilnius, LT-08661

Other trials in Lithuania

South Korea3 sites

  • Gachon University Gil Medical Center

    Incheon, 405760

  • VHS Medical Center

    Seoul, 05369

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

    Seoul, 137701

Other trials in South Korea

Belgium2 sites

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

  • Liège - HOSP CHR de la Citadelle

    Liège, 4000

Other trials in Belgium

Croatia2 sites

  • Clinical Hospital Centar Sestre Milosrdnice

    Zagreb, 10000

  • UHC Zagreb

    Zagreb, 10000

Other trials in Croatia

Denmark2 sites

  • Herlev Hospital

    Herlev, 2730

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Switzerland2 sites

  • Kantonsspital Aarau

    Aarau, CH-5001

  • Kantonsspital Baden AG

    Baden, CH-5404

Other trials in Switzerland

Slovakia1 site

  • Faculty Hospital Trnava

    Trnava, 91775

Other trials in Slovakia

About this study

Official title: Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Docetaxel Therapy Compared to Placebo Plus Standard Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cell Lung Cancer After Failure of First Line Chemotherapy

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.

Being tested
placebo plus docetaxel, BIBF 1120 plus docetaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • placebo plus docetaxelDrug

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

  • BIBF 1120 plus docetaxelDrug

    BIBF 1120 2 times daily along with standard therapy of docetaxel

Study groups in NCT00805194
Study groupRoleWhat they receive
BIBF 1120 plus docetaxelExperimentalBIBF 1120 2 times daily along with standard therapy of docetaxel
Receives: Drug: BIBF 1120 plus docetaxel
Placebo plus docetaxelPlacebo comparatorPlacebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel
Receives: Drug: placebo plus docetaxel

What is being measured

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

  1. Progression Free Survival (PFS) as Assessed by Central Independent Review

    Progression Free Survival (PFS) as assessed by central independent review according to the modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) . Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).

    Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.

    Measured: From randomisation until cut-off date 2 November 2010 (when 713 PFS events were observed)

Secondary outcomes (13)

  1. Overall Survival (Key Secondary Endpoint)

    Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.

    A fixed-sequence-testing was implemented for key secondary endpoint if both the primary and the follow-up analysis showed a treatment benefit (P<0.05) of nintedanib over placebo. In this case, the OS would be tested using hierarchical testing of statistical hypotheses in (1) patients with adenocarcinoma and <9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been.

    Measured: From randomisation until cut-off date 15 February 2013 (approximately 48 months or 1151 deaths among all patients )

  2. Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review

    Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria.

    Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.

    Measured: From randomisation until cut-off date 15 February 2013

  3. Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator

    Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria.

    Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.

    Measured: From randomisation until cut-off date 15 February 2013

  4. Objective Tumour Response

    Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0.

    As per RECIST v1.0, Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

    This endpoint was analysed based on the central independent reviewer as well as the investigator.

    Measured: From randomisation until cut-off date 15 February 2013

  5. Duration of Confirmed Objective Tumour Response

    The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0.

    As per RECIST v1.0, Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

    Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.

    This endpoint was analysed based on the central independent reviewer as well as the investigator.

    Measured: From randomisation until cut-off date 15 February 2013

  6. Time to Confirmed Objective Tumour Response

    Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0.

    Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.

    This endpoint was analysed based on the central independent reviewer as well as the investigator.

    Measured: From randomisation until cut-off date 15 February 2013

  7. Disease Control

    Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.

    As per RECIST v1.0 for target lesions : Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

    This endpoint was analysed based on the central independent reviewer as well as the investigator.

    Measured: From randomisation until cut-off date 15 February 2013

  8. Duration of Disease Control

    The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control.

    Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.

    This endpoint was analysed based on the central independent reviewer as well as the investigator.

    Measured: From randomisation until cut-off date 15 February 2013

  9. Change From Baseline in Tumour Size

    Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion.

    Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)

    This endpoint was analysed based on the central independent reviewer as well as the investigator.

    Measured: From randomisation until cut-off date 15 February 2013

  10. Clinical Improvement

    Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.

    Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.

    Measured: From randomisation until cut-off date 15 February 2013

  11. Quality of Life (QoL)

    Quality of life (QoL) was measured by standardised questionnaires (Health Status Self-Assessment Questionnaire (EQ-5D), EORTC Quality of life questionnaire - Core 30 (EORTC QLQ-C30), Quality of life questionnaire - lung cancer module (EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items.

    The following were the main points of interest:

    Time to deterioration of cough (EORTC QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19).

    Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.

    Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve

    Measured: From randomisation until cut-off date 15 February 2013

  12. Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide

    Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm.

    Measured: Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3

  13. Incidence and Intensity of Adverse Events

    Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.

    Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint.

    Measured: From the first drug administration until 28 days after the last drug administration, up to 42 months

Timeline

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

  1. First posted9 Dec 2008 (estimated)
  2. Study start3 Dec 2008
  3. Primary completion2 Nov 2010
  4. Study completion13 Nov 2017

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
1,314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00805194
Sponsor's protocol ID
1199.13
Other IDs
2007-004803-36
Status last verified
Nov 2018
First submitted
8 Dec 2008
Last updated
5 Dec 2018

Publications

  • 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.

    PubMed 28702806

  • 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.

    PubMed 24411639

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BIBF 1120 plus docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 210 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 7 inclusion and 34 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: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 210 sites in Germany, China, India, Russia, Italy 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 phase mean?

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 1 Dec 2014). 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) as Assessed by Central Independent Review (time frame: From randomisation until cut-off date 2 November 2010 (when 713 PFS events were observed)). 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 NCT00805194, which also lists 2 linked publications.

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 5 Dec 2018.

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