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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00805194
Recruitment Status : Completed
First Posted : December 9, 2008
Results First Posted : December 1, 2014
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: placebo plus docetaxel Drug: BIBF 1120 plus docetaxel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Actual Study Start Date : December 3, 2008
Actual Primary Completion Date : November 2, 2010
Actual Study Completion Date : November 13, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: BIBF 1120 plus docetaxel
BIBF 1120 2 times daily along with standard therapy of docetaxel
Drug: BIBF 1120 plus docetaxel
BIBF 1120 2 times daily along with standard therapy of docetaxel
Placebo Comparator: Placebo plus docetaxel
Placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel
Drug: placebo plus docetaxel
placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel



Primary Outcome Measures :
  1. 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) ]

    Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. 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.



Secondary Outcome Measures :
  1. Overall Survival (Key Secondary Endpoint) [ Time Frame: From randomisation until cut-off date 15 February 2013 (approximately 48 months or 1151 deaths among all patients ) ]

    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.


  2. Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

    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.


  3. Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

    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.


  4. Objective Tumour Response [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

    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.

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


  5. Duration of Confirmed Objective Tumour Response [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

    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.

    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.


  6. Time to Confirmed Objective Tumour Response [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

    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.


  7. Disease Control [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

    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.

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


  8. Duration of Disease Control [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

    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.


  9. Change From Baseline in Tumour Size [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

    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.


  10. Clinical Improvement [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

    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.


  11. Quality of Life (QoL) [ Time Frame: From randomisation until cut-off date 15 February 2013 ]

    QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, 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 (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


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

  13. Incidence and Intensity of Adverse Events [ Time Frame: From the first drug administration until 28 days after the last drug administration, up to 42 months ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805194


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Locations
Austria
LKH-Univ. Klinikum Graz
Graz, Austria, 8036
KH St. Vinzenz, Zams, Int. Abtlg.
Kufstein, Austria, 6330
AKH d. Stadt Linz, Pulmologie
Linz, Austria, 4020
Belarus
Bobruisk Inter-distict
Bobruisk, Belarus, 213825
Brest Regional Clinical
Brest Region, Belarus, 224027
Gomel Regional Clinical
Gomel, Belarus, 246012
Scientific Research Minsk
Minsk Region, Belarus, 223040
Public Health Inst. Minsk City Clinical Oncology Dispensary
Minsk, Belarus, 220013
Mogilov Regional Oncological Dispensary
Mogilov, Belarus, 212018
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, Belarus, 210603
Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium, 4000
Liège - HOSP CHR de la Citadelle
Liège, Belgium, 4000
Bulgaria
Multiprofile Hospital for Active Treatment
Gabrovo, Bulgaria, 5300
Univ.Multiprofile Hospital "Dr. Georgy Stranski" EAD, Pleven
Pleven, Bulgaria, 5800
District Oncology Dispensary Plovdiv
Plovdiv, Bulgaria, 4004
Interdistrict Oncology Dispensary, Ruse
Ruse, Bulgaria, 7002
District Oncology Dispensary Shumen
Shumen, Bulgaria, 9700
Specialized Hospital for Active Treatment in Oncolcogy
Sofia, Bulgaria, 1756
China
307 Hospital of PLA
Beijing, China, 100071
Jilin Province Cancer Hospital
Changchun, China, 130012
First Hospital of Jilin University
Changchun, China, 130021
West China Hospital
Chengdu, China, 610041
Southwest Hospital
Chongqing, China, 400038
First Affiliated Hospital of Dalian Medical University
Dalian, China, 116011
The Second Affiliated Hospital of Dalian Medical University
Dalian, China, 116027
Fujian Provincial Tumor Hospital
Fujian, China, 350014
Sun Yat-Sen University Cancer Center
Guangzhou, China, 510060
Guangdong General Hospital
Guangzhou, China, 510080
Sir Run Run Shaw Hospital
Hangzhou, China, 310016
Zhejiang Cancer Hospital
Hangzhou, China, 310022
The Third Affiliated Hospital of Harbin Medical University
Harbin, China, 150081
the 81th Hospital of PLA
Nanjing, China, 210002
Jiangsu Cancer Hospital
Nanjing, China, 210009
Shanghai Chest Hospital
Shanghai, China, 200030
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Tongji Hospital
Wuhan, China, 430030
Zhongshan Hospital Fudan University
Xuhui Area, Shanghai, China, 200032
Croatia
Clinic for Lung Diseases 'Jordanovac', Zagreb
Zagreb, Croatia, 10000
Clinical Hospital Centar Sestre Milosrdnice
Zagreb, Croatia, 10000
Czechia
University Hospital Brno
Brno, Czechia, 625 00
St. Anna Hospital, 2nd Internal Department
Brno, Czechia, 656 53
District Hospital Liberec
Liberec, Czechia, 460 01
Institut onkologie a rehabilitace Na Plesi s.r.o.
Nova Ves pod Plesi, Czechia, 262 04
District Hospital Pribram, Oncology Centrum
Pribram, Czechia, 261 95
Denmark
Herlev Hospital
Herlev, Denmark, 2730
Odense Universitetshospital
Odense C, Denmark, 5000
France
HOP Croix Rousse, Pneumo, Lyon
Lyon Cedex 4, France, 69317
INS Paoli-Calmettes
Marseille Cedex 9, France, 13273
HOP Lyon Sud
Pierre Bénite cedex, France, 69495
CHU de Rouen - Hôpital de Bois Guillaume
ROUEN cedex, France, 76031
HOP Nord Laënnec
Saint Herblain cedex, France, 44805
Oncology Institute of the Loire
Saint-Priest en Jarez, France, 42271
HOP Civil
Strasbourg cedex, France, 67091
Sainte Anne Training hospital for the armies
Toulon Cedex 09, France, 83401
Georgia
Amtel Hospital first Clinical LLC
Tbilisi, Georgia, 0079
National Centre of Oncology
Tbilisi, Georgia, 0177
Chemotherapy &amp;amp; Immunotherapy Clinic 'Medulla', Tbilisi
Tbilisi, Georgia, 0186
Germany
Gemeinschaftspraxis Dr. Brudler / Dr. Heinrich, Augsburg
Augsburg, Germany, 86150
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437
Evangelische Lungenklinik Berlin
Berlin-Buch, Germany, 13125
Universitätsklinikum Benjamin Franklin, Berlin
Berlin, Germany, 12200
HELIOS Klinikum Emil von Behring GmbH
Berlin, Germany, 14165
Krankenhaus Nordwest, Frankfurt
Frankfurt/Main, Germany, 60488
Klinikum Frankfurt Höchst GmbH
Frankfurt/Main, Germany, 65929
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
Universitätsklinikum Freiburg
Freiburg, Germany, 79106
Asklepios Fachkliniken München-Gauting
Gauting, Germany, 82131
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany, 22927
Städisches Krankenhaus Martha-Maria, Halle/Saale
Halle/Saale, Germany, 06120
Allgemeines Krankenhaus Harburg, 21075 Hamburg
Hamburg, Germany, 21075
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69126
Klinikum Kassel GmbH
Kassel, Germany, 34125
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24116
Gemeinschaftspraxis für Hämatologie und Onkologie, Köln
Köln, Germany, 50677
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Praxis Dr. Gessner, Leipzig
Leipzig, Germany, 04357
Klinik, Löwenstein
Löwenstein, Germany, 74245
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Lübeck, Germany, 23538
Katholisches Klinikum St. Hildegardiskrankenhaus, Mainz
Mainz, Germany, 55131
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, D-55131
Universitätsklinik links der Isar, München, Ziemssenstr. 1
München, Germany, 80336
Klinikum rechts der Isar TU, München, Ismaninger Str. 22
München, Germany, 81675
Städt. Krankenhaus, München-Bogenhausen
München, Germany, 81925
Pius-Hospital, Oldenburg
Oldenburg, Germany, 26121
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Dr. Horst-Schmidt-Kliniken, Wiesbaden
Wiesbaden, Germany, 65199
Evangelisches Krankenhaus, Witten
Witten, Germany, 58455
Greece
Athens Hospital of Chest Diseasea "SOTIRIA"
Athens, Greece, 11527
University Hospital of Heraklion, University Pulmonology Cl
Heraklio, Greece, 71110
Iaso General Hospital
Holargos, Athens, Greece, 15562
Papageorgiou Hospital, 1st Cardiological Cl., Thessaloniki
Thessaloniki, Greece, 54603
General Hospital "Papanikolaou"
Thessaloniki, Greece, 57010
India
Vedanta Institute of Medical Sciences
Ahmedabad, India, 380009
KIDWAI memoraial Institute of oncology
Bangalore, India, 560029
Rajalakshmi Multispeciality Hospital
Bangalore, India, 560078
Jawaharlal Nehru Cancer Hospital & Research Centre
Bhopal, M.P., India, 462001
Apollo Hospital
Chennai, India, 600035
SEAROC cancer center,S.K.soni Hospital
Jaipur, Rajasthan, India, 302013
Birla Cancer Centre
Jaipur, India, 302004
Bhagwan Mahaveer Cancer Hospital & Research Center, Jawahar
Jaipur, India, 302017
B. P .Poddar Hospital & Medical Research Ltd.
Kolkata, West Bengal, India, 700053
Kasturba Medical College and Hospital
Mangalore, India, 575001
Tata Memorial Centre
Mumbai, India, 400012
Shatabdi Superspeciality Hospital
Nashik, India, 422005
Sir Gangaram Hospital
New Delhi, India, 110060
Indraprastha Apollo Hospital
New Delhi, India, 110076
Rajiv Gandhi Cancer Institute and Clinical Research
New Delhi, India, 110085
Jehangir Hospital Oncology Department
Pune, Maharahtra, India, 411001
Regional Cancer Center
Trivandrum, Kerala, India, 695011
City Cancer Centre, Cancer Hospital & Research
Vijayawada, India, 520002
King George Hospital
Visakhapatnam, India, 530002
Israel
E. Wolfson Medical Center, Holon 58100
Holon, Israel, 58100
Hadassah medical organization, Jerusalem 91120
Jerusalem, Israel, 91120
Meir Medical Center
Kfar Saba, Israel, 44281
The Chaim Sheba Medical Center Tel Hashomer
Tel Hashomer, Israel, 52621
Sourasky Medical Center
Tel-Aviv, Israel, 64239
Assaf Harofe Medical Center
Zerifin, Israel, 70300
Italy
Az. Ospedaliere Umberto I di Ancona
Ancona, Italy, 60020
Centro di riferimento Oncologico
Aviano, Italy, 33081
Policlinico S. Orsola Malpighi
Bologna, Italy, 40135
Fond. Poliambulanza Istituto
Brescia, Italy, 25124
Azienda Ospedaliera Careggi
Firenze, Italy, 50139
Ospedale Civile
Ivrea (TO), Italy, 10015
Istituto Scientifico Romagnolo
Meldola, Italy, 47014
ASST Grande Ospedale Metropolitano Niguarda
Milano, Italy, 20162
Azienda Sanitaria Ospedale S. Luigi Gonzaga
Orbassano, Italy, 10043
Fondazione Salvatore Maugeri
Pavia, Italy, 27100
Ospedale S.Maria della Misericordia, AO di Perugia
Perugia, Italy, 06132
Korea, Republic of
Seoul Veterans Hospital
Gangdong-gu, Seoul, Korea, Republic of, 134791
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405760
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, Korea, Republic of, 137701
Lithuania
Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos
Kaunas, Lithuania, LT-50009
Siauliu ligonine, Siauliai
Siauliai, Lithuania, 76307
Vilniaus Universiteto
Vilnius, Lithuania, LT-08661
Poland
Pulmonology Center in Bydgoszcz
Bydgoszcz, Poland, 85-326
Regional Complex Hospital
Elblag, Poland, 82-300
Institute of Tuberculosis & Pulmonology, III. Dept., Olsztyn
Olsztyn, Poland, 10-357
Mazowieckiego Centrum
Otwock, Poland, 05-400
Wielkopolski Center Pulmonology+Tuberculosis P-III, Poznan
Poznan, Poland, 60-569
Regional Specialist Hospital
Slupsk, Poland, 76-200
Independent Public Hospital in Suwalki
Suwalki, Poland, 16-400
Specialist Hospital, Szczecin-Zdunowo
Szczecin, Poland, 70-891
Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer
Warszawa, Poland, 02-781
Portugal
IPO Porto Francisco Gentil, EPE, Oncology Dep.
Coimbra, Portugal, 3041-801
IPO Lisboa Francisco Gentil, EPE
Lisboa, Portugal, 1099-023
CHLN, EPE - Hospital de Santa Maria
Lisboa, Portugal, 1649-035
IPO Porto Francisco Gentil, EPE, Oncology Dep.
Porto, Portugal, 4200-072
Centro Hospitalar São João,EPE
Porto, Portugal, 4200-319
CHS, EPE - Hospital de São Bernardo
Setúbal, Portugal, 2910
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, Portugal, 4434-502
Romania
Baia Mare Emergency County Hospital
Baia Mare, Romania, 430031
Spitalul Clinic Judetean de Urgenta Brasov
Brasov, Romania, 500117
Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'
Bucuresti, Romania, 022328
Institutul Oncologic &quot;Prof. Dr. Ion Chiricuta&quot;
Cluj-Napoca, Romania, 400015
County Hospital "Dr. Alex Simionescu"
Hunedoara, Romania, 331057
Centrul de Oncologie Medicala
Iasi, Romania, 700106
Emergency Clinical County Hospital &quot;Sf Spiridon&quot;, Iasi
Iasi, Romania, 700111
Onesti County Hospital
Onesti, Romania, 601048
Emergency County Hospital &quot;Sf.loan cel Nou&quot;
Suceava, Romania, 720237
Oncomed SRL
Timisoara, Romania, 300239
Russian Federation
SBIH of Arkhangelsk reg. &quot;Arkhangelsk Clin. Onc. Dispensary&quot;
Arkhangelsk, Russian Federation, 163045
GLPU Cheliabinsky
Chelyabinsk, Russian Federation, 454076
GUZ Irkutsk Regional Oncology Dispensary
Irkutsk, Russian Federation, 664035
Republic Clinical Oncology Dispensary, Dept. Chemotherapy
Kazan, Russian Federation, 420029
RBIH "Kursk regional clinical oncology dispensary"
Kursk, Russian Federation, 305035
GUZ Regional Oncology Dispensary, Magnitogorsk
Magnitogorsk, Russian Federation, 455001
FSBSI "Russian Oncol. Scientific Center n.a. N.N. Blokhin"
Moscow, Russian Federation, 115478
SBIH of Stavropol territory &quot;Pyatigorsk Oncol. Dispensary&quot;
Pyatigorsk, Russian Federation, 357502
GUZ &quot;Regional Clinical Oncology Dispensary&quot;
Ryazan, Russian Federation, 390011
GUZ "Oncological Dispesary #2"
Sochi, Russian Federation, 354057
GUZ Leningradskaya Regional Clin. Hospital, St. Petersburg
St. Petersburg, Russian Federation, 194291
First Pavlov State Medical University Saint Petersburg
St. Petersburg, Russian Federation, 197022
SPb SBIH &quot;City Clinical Oncological Dispensary&quot;
St. Petersburg, Russian Federation, 197022
Research Institute of Oncology n.a. Petrov, Diagnost. Dept.
St. Petersburg, Russian Federation, 197758
GUZ Sverdlovsky Regional Oncology Dispensary
Yekaterinburg, Russian Federation, 620036
Slovakia
Faculty Hospital Trnava
Trnava, Slovakia, 91775
South Africa
GVI oncology Medi Clinic
Cape Town, South Africa, 7570
Parklands Hospital
Durban, South Africa, 4091
Wits Donald Gordon Clinical Trial Site
Johannesburg, South Africa, 2193
Medical Oncology Centre of Rosebank
Johannesburg, South Africa, 2196
Langenhoven Drive Oncology Centre
Port Elizabeth, South Africa, 6045
Pretoria Academic Hospital
Pretoria, South Africa, 0001
Wilgers oncology
Pretoria, South Africa, 0041
Spain
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario de Elche
Elche, Spain, 03202
Hospital Jerez de la Frontera
Jerez De La Frontera-Cádiz, Spain, 11407
Hospital La Princesa
Madrid, Spain, 28006
Hospital Quirónsalud Madrid
Pozuelo de Alarcon, Spain, 28233
Fundación Instituto Valenciano de Oncologia
Valencia, Spain, 46009
Servicio de Oncologia Radiotherapica
Valencia, Spain, 46010
Hospital Arnau de Vilanova
Valencia, Spain, 46015
Switzerland
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
Kantonsspital Baden AG
Baden, Switzerland, CH-5404
Ukraine
Chernigiv Regional Oncology Centre
Chernigiv, Ukraine, 14029
Bukovynsk State Medical University
Chernivtsi, Ukraine, 58013
Chmelnytskyi Oblasnnyi Oncologichnyi Tsentr
Chmelnytskyi, Ukraine, 29000
City Clinical Hospital #4, Dnipropetrovsk State Medical Academy
Dnipropetrovsk, Ukraine, 49102
Donetsk Regional Antitumor Centre
Donetsk, Ukraine, 83000
Kharkiv Medical Acadamy of Postgraduate education
Kharkiv, Ukraine, 61070
Kryvorizskyi regional communal clinical oncology centre
Kryvyi Rig, Ukraine, 50048
Odesa Regional Oncological Centre
Odesa, Ukraine, 65055
Ternopil regional communal clinical oncology centre
Ternopil, Ukraine, 46023
Uzhgorod National University, Oncology Centre
Uzhgorod, Ukraine, 88000
Vinnytsia Regional Clinical Oncological Dispensary
Vinnytsia, Ukraine, 21029
United Kingdom
Royal Bournemouth and Christchurch Hospital
Bournemouth, United Kingdom, BH7 7DW
Bristol Haematology & Onc. Ctr
Bristol, United Kingdom, BS28ED
Broomfield Hospital
Chelmsford, United Kingdom, CM1 7ET
Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Poole Hospital
Poole, United Kingdom, BH15 2JB
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00805194     History of Changes
Other Study ID Numbers: 1199.13
2007-004803-36 ( EudraCT Number )
First Posted: December 9, 2008    Key Record Dates
Results First Posted: December 1, 2014
Last Update Posted: December 13, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Nintedanib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors