Spots Global Cancer Trial Database for LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer
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Trial Identification
Brief Title: LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer
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
Study ID: NCT00805194
Conditions
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
LKH-Univ. Hospital Graz, Graz, , Austria
KH St. Vinzenz, Zams, Int. Abtlg., Kufstein, , Austria
AKH d. Stadt Linz, Pulmologie, Linz, , Austria
Bobruisk Inter-distict, Bobruisk, , Belarus
Brest Regional Clinical, Brest Region, , Belarus
Gomel Regional Clinical, Gomel, , Belarus
Scientific Research Minsk, Minsk Region, , Belarus
Public Health Inst. Minsk City Clinical Oncology Dispensary, Minsk, , Belarus
Mogilov Regional Oncological Dispensary, Mogilov, , 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, Ruse, , 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., Nova Ves pod Plesi, , Czechia
District Hospital Pribram, Oncology Centrum, Pribram, , Czechia
Herlev Hospital, Herlev, , Denmark
Odense Universitetshospital, Odense C, , Denmark
HOP Croix Rousse, Pneumo, Lyon, Lyon Cedex 4, , France
INS Paoli-Calmettes, Marseille Cedex 9, , France
HOP Lyon Sud, Pierre Bénite cedex, , France
CHU de Rouen - Hôpital de Bois Guillaume, ROUEN cedex, , France
HOP Nord Laënnec, Saint Herblain cedex, , France
Oncology Institute of the Loire, Saint-Priest en Jarez, , France
HOP Civil, Strasbourg cedex, , France
Sainte Anne Training hospital for the armies, Toulon Cedex 09, , 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
Evangelische Lungenklinik Berlin, Berlin-Buch, , Germany
Universitätsklinikum Benjamin Franklin, Berlin, Berlin, , Germany
Helios Klinikum Emil von Behring, Berlin, , Germany
Krankenhaus Nordwest, Frankfurt, Frankfurt/Main, , Germany
Klinikum Frankfurt Höchst GmbH, Frankfurt/Main, , Germany
Universitätsklinikum Frankfurt, Frankfurt, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
Asklepios Fachkliniken München-Gauting, Gauting, , Germany
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH, Großhansdorf, , Germany
Krankenhaus Martha-Maria Halle-Dölau gGmbH, Halle/Saale, , Germany
Allgemeines Krankenhaus Harburg, 21075 Hamburg, Hamburg, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
Klinikum Kassel GmbH, Kassel, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, , Germany
Gemeinschaftspraxis für Hämatologie und Onkologie, Köln, Köln, , 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
SEAROC cancer center,S.K.soni Hospital, Jaipur, Rajasthan, , India
Birla Cancer Centre, Jaipur, , India
Bhagwan Mahaveer Cancer Hospital & Research Center, Jawahar, Jaipur, , 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
The Chaim Sheba Medical Center Tel Hashomer, Tel Hashomer, , Israel
Sourasky Medical Center, Tel-Aviv, , Israel
Assaf Harofe Medical Center, Zerifin, , 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, Firenze, , Italy
Ospedale Civile, Ivrea (TO), , Italy
Istituto Scientifico Romagnolo, Meldola, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Azienda Sanitaria Ospedale S. Luigi Gonzaga, Orbassano, , Italy
Fondazione Salvatore Maugeri, Pavia, , Italy
Ospedale S.Maria della Misericordia, AO di Perugia, Perugia, , Italy
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
VHS Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St.Mary's Hospital, Seoul, , Korea, Republic of
Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos, Kaunas, , Lithuania
Siauliu ligonine, Siauliai, Siauliai, , 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
Regional Specialist Hospital, Slupsk, , Poland
Independent Public Hospital in Suwalki, Suwalki, , Poland
Specialist Hospital, Szczecin-Zdunowo, Szczecin, , Poland
Onco.Cent. - Instit. of Maria Sklodowskiej-Curie, Warszawa, , Poland
IPO Porto Francisco Gentil, EPE, Coimbra, , Portugal
IPO Lisboa Francisco Gentil, EPE, Lisboa, , Portugal
CHLN, EPE - Hospital de Santa Maria, Lisboa, , 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', Bucuresti, , Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta", Cluj-Napoca, , Romania
County Hospital "Dr. Alex Simionescu", Hunedoara, , Romania
Centrul de Oncologie Medicala, Iasi, , Romania
Emergency Clinical County Hospital "Sf Spiridon", Iasi, Iasi, , Romania
Onesti County Hospital, Onesti, , Romania
Emergency County Hospital "Sf.loan cel Nou", Suceava, , Romania
Oncomed SRL, Timisoara, , Romania
SBIH of Arkhangelsk reg. "Arkhangelsk Clin. Onc. Dispensary", Arkhangelsk, , Russian Federation
GLPU Cheliabinsky, Chelyabinsk, , Russian Federation
GUZ Irkutsk Regional Oncology Dispensary, Irkutsk, , Russian Federation
St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan", Kazan, , Russian Federation
RBIH "Kursk regional clinical oncology dispensary", Kursk, , Russian Federation
GUZ Regional Oncology Dispensary, Magnitogorsk, Magnitogorsk, , Russian Federation
FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF, Moscow, , Russian Federation
SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary", Pyatigorsk, , Russian Federation
GUZ "Regional Clinical Oncology Dispensary", Ryazan, , Russian Federation
GUZ "Oncological Dispesary #2", Sochi, , Russian Federation
GUZ Leningradskaya Regional Clin. Hospital, St. Petersburg, St. Petersburg, , Russian Federation
1stPavlov St.Med.Univ.St.-Petersburg Res.Inst., St. Petersburg, , Russian Federation
SPb SBIH "City Clinical Oncological Dispensary", St. Petersburg, , Russian Federation
FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF, St. Petersburg, , Russian Federation
GUZ Sverdlovsky Regional Oncology Dispensary, Yekaterinburg, , Russian Federation
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
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 Alarcon, , 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, Chernigiv, , 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, Uzhgorod, , 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
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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