Clinical trial NCT00805194: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-12-09
Enrollment: 1314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression Free Survival (PFS) as Assessed by Central Independent Review
timeFrame: From randomisation until cut-off date 2 November 2010 (when 713 PFS events were observed)
Secondary outcomes:
measure: Overall Survival (Key Secondary Endpoint)
timeFrame: From randomisation until cut-off date 15 February 2013 (approximately 48 months or 1151 deaths among all patients )
measure: Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review
timeFrame: From randomisation until cut-off date 15 February 2013
measure: Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator
timeFrame: From randomisation until cut-off date 15 February 2013
measure: Objective Tumour Response
timeFrame: From randomisation until cut-off date 15 February 2013
measure: Duration of Confirmed Objective Tumour Response
timeFrame: From randomisation until cut-off date 15 February 2013
measure: Time to Confirmed Objective Tumour Response
timeFrame: From randomisation until cut-off date 15 February 2013
measure: Disease Control
timeFrame: From randomisation until cut-off date 15 February 2013
measure: Duration of Disease Control
timeFrame: From randomisation until cut-off date 15 February 2013
measure: Change From Baseline in Tumour Size
timeFrame: From randomisation until cut-off date 15 February 2013
measure: Clinical Improvement
timeFrame: From randomisation until cut-off date 15 February 2013
measure: Quality of Life (QoL)
timeFrame: From randomisation until cut-off date 15 February 2013
measure: Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide
timeFrame: 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
measure: Incidence and Intensity of Adverse Events
timeFrame: From the first drug administration until 28 days after the last drug administration, up to 42 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH-Univ. Hospital Graz
city: Kufstein
country: Austria
facility: KH St. Vinzenz, Zams, Int. Abtlg.
city: Linz
country: Austria
facility: AKH d. Stadt Linz, Pulmologie
city: Bobruisk
country: Belarus
facility: Bobruisk Inter-distict
city: Brest Region
country: Belarus
facility: Brest Regional Clinical
city: Gomel
country: Belarus
facility: Gomel Regional Clinical
city: Minsk Region
country: Belarus
facility: Scientific Research Minsk
city: Minsk
country: Belarus
facility: Public Health Inst. Minsk City Clinical Oncology Dispensary
city: Mogilov
country: Belarus
facility: Mogilov Regional Oncological Dispensary
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Oncology Dispensary
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Liège
country: Belgium
facility: Liège - HOSP CHR de la Citadelle
city: Gabrovo
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment
city: Pleven
country: Bulgaria
facility: Univ.Multiprofile Hospital "Dr. Georgy Stranski" EAD, Pleven
city: Plovdiv
country: Bulgaria
facility: District Oncology Dispensary Plovdiv
city: Ruse
country: Bulgaria
facility: Interdistrict Oncology Dispensary, Ruse
city: Shumen
country: Bulgaria
facility: District Oncology Dispensary Shumen
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment in Oncolcogy
city: Beijing
country: China
facility: 307 Hospital of PLA
city: Changchun
country: China
facility: Jilin Province Cancer Hospital
city: Changchun
country: China
facility: First Hospital of Jilin University
city: Chengdu
country: China
facility: West China Hospital
city: Chongqing
country: China
facility: Southwest Hospital
city: Dalian
country: China
facility: First Affiliated Hospital of Dalian Medical University
city: Dalian
country: China
facility: The Second Affiliated Hospital of Dalian Medical University
city: Fujian
country: China
facility: Fujian Provincial Tumor Hospital
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: The Third Affiliated Hospital of Harbin Medical University
city: Nanjing
country: China
facility: the 81th Hospital of PLA
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Wuhan
country: China
facility: Tongji Hospital, Tongji University
city: Xuhui Area, Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Zagreb
country: Croatia
facility: Clinical Hospital Centar Sestre Milosrdnice
city: Zagreb
country: Croatia
facility: UHC Zagreb
city: Brno
country: Czechia
facility: University Hospital Brno
city: Brno
country: Czechia
facility: St. Anna Hospital, 2nd Internal Department
city: Liberec
country: Czechia
facility: District Hospital Liberec
city: Nova Ves pod Plesi
country: Czechia
facility: Institut onkologie a rehabilitace Na Plesi s.r.o.
city: Pribram
country: Czechia
facility: District Hospital Pribram, Oncology Centrum
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Lyon Cedex 4
country: France
facility: HOP Croix Rousse, Pneumo, Lyon
city: Marseille Cedex 9
country: France
facility: INS Paoli-Calmettes
city: Pierre Bénite cedex
country: France
facility: HOP Lyon Sud
city: ROUEN cedex
country: France
facility: CHU de Rouen - Hôpital de Bois Guillaume
city: Saint Herblain cedex
country: France
facility: HOP Nord Laënnec
city: Saint-Priest en Jarez
country: France
facility: Oncology Institute of the Loire
city: Strasbourg cedex
country: France
facility: HOP Civil
city: Toulon Cedex 09
country: France
facility: Sainte Anne Training hospital for the armies
city: Tbilisi
country: Georgia
facility: Amtel Hospital first Clinical LLC
city: Tbilisi
country: Georgia
facility: National Centre of Oncology
city: Tbilisi
country: Georgia
facility: Chemotherapy & Immunotherapy Clinic 'Medulla', Tbilisi
city: Augsburg
country: Germany
facility: Gemeinschaftspraxis Dr. Brudler / Dr. Heinrich, Augsburg
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Berlin-Buch
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Berlin
country: Germany
facility: Universitätsklinikum Benjamin Franklin, Berlin
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring
city: Frankfurt/Main
country: Germany
facility: Krankenhaus Nordwest, Frankfurt
city: Frankfurt/Main
country: Germany
facility: Klinikum Frankfurt Höchst GmbH
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Gauting
country: Germany
facility: Asklepios Fachkliniken München-Gauting
city: Großhansdorf
country: Germany
facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
city: Halle/Saale
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau gGmbH
city: Hamburg
country: Germany
facility: Allgemeines Krankenhaus Harburg, 21075 Hamburg
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Köln
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie, Köln
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Leipzig
country: Germany
facility: POIS Leipzig GbR
city: Löwenstein
country: Germany
facility: Klinik, Löwenstein
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Mainz
country: Germany
facility: Katholisches Klinikum St. Hildegardiskrankenhaus, Mainz
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: München
country: Germany
facility: Universitätsklinik links der Isar, München, Ziemssenstr. 1
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
city: München
country: Germany
facility: Städt. Krankenhaus, München-Bogenhausen
city: Oldenburg
country: Germany
facility: Pius-Hospital, Oldenburg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Wiesbaden
country: Germany
facility: Helios Dr. Horst Schmidt Kliniken Wiesbaden
city: Witten
country: Germany
facility: Evangelisches Krankenhaus, Witten
city: Athens
country: Greece
facility: Athens Hospital of Chest Diseasea "SOTIRIA"
city: Heraklio
country: Greece
facility: University Hospital of Heraklion, University Pulmonology Cl
city: Holargos, Athens
country: Greece
facility: Iaso General Hospital
city: Thessaloniki
country: Greece
facility: Papageorgiou Hospital, 1st Cardiological Cl., Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G. Papanikolaou"
city: Ahmedabad
country: India
facility: Vedanta Institute of Medical Sciences
city: Bangalore
country: India
facility: KIDWAI memoraial Institute of oncology
city: Bangalore
country: India
facility: Rajalakshmi Multispeciality Hospital
city: Bhopal, M.P.
country: India
facility: Jawaharlal Nehru Cancer Hospital & Research Centre
city: Chennai
country: India
facility: Apollo Hospital
city: Jaipur, Rajasthan
country: India
facility: SEAROC cancer center,S.K.soni Hospital
city: Jaipur
country: India
facility: Birla Cancer Centre
city: Jaipur
country: India
facility: Bhagwan Mahaveer Cancer Hospital & Research Center, Jawahar
city: Kolkata, West Bengal
country: India
facility: B. P .Poddar Hospital & Medical Research Ltd.
city: Mangalore
country: India
facility: Kasturba Medical College and Hospital
city: Mumbai
country: India
facility: Tata Memorial Centre
city: Nashik
country: India
facility: Shatabdi Superspeciality Hospital
city: New Delhi
country: India
facility: Sir Gangaram Hospital
city: New Delhi
country: India
facility: Indraprastha Apollo Hospitals
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute and Research Centre
city: Pune, Maharahtra
country: India
facility: Jehangir Hospital Oncology Department
city: Trivandrum, Kerala
country: India
facility: Regional Cancer Center
city: Vijayawada
country: India
facility: City Cancer Centre, Cancer Hospital & Research
city: Visakhapatnam
country: India
facility: King George Hospital
city: Holon
country: Israel
facility: E. Wolfson Medical Center, Holon 58100
city: Jerusalem
country: Israel
facility: Hadassah Medical Center, Ein-Karem
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center Tel Hashomer
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofe Medical Center
city: Ancona
country: Italy
facility: Az. Ospedaliere Umberto I di Ancona
city: Aviano
country: Italy
facility: Centro di riferimento Oncologico
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi
city: Brescia
country: Italy
facility: Fond. Poliambulanza Istituto
city: Firenze
country: Italy
facility: Azienda Ospedaliera Careggi
city: Ivrea (TO)
country: Italy
facility: Ospedale Civile
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Orbassano
country: Italy
facility: Azienda Sanitaria Ospedale S. Luigi Gonzaga
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri
city: Perugia
country: Italy
facility: Ospedale S.Maria della Misericordia, AO di Perugia
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St.Mary's Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos
city: Siauliai
country: Lithuania
facility: Siauliu ligonine, Siauliai
city: Vilnius
country: Lithuania
facility: Vilniaus Universiteto
city: Bydgoszcz
country: Poland
facility: Pulmonology Center in Bydgoszcz
city: Elblag
country: Poland
facility: Regional Complex Hospital
city: Olsztyn
country: Poland
facility: Institute of Tuberculosis & Pulmonology, III. Dept., Olsztyn
city: Otwock
country: Poland
facility: Mazowieckiego Centrum
city: Poznan
country: Poland
facility: Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland
city: Slupsk
country: Poland
facility: Regional Specialist Hospital
city: Suwalki
country: Poland
facility: Independent Public Hospital in Suwalki
city: Szczecin
country: Poland
facility: Specialist Hospital, Szczecin-Zdunowo
city: Warszawa
country: Poland
facility: Onco.Cent. - Instit. of Maria Sklodowskiej-Curie
city: Coimbra
country: Portugal
facility: IPO Porto Francisco Gentil, EPE
city: Lisboa
country: Portugal
facility: IPO Lisboa Francisco Gentil, EPE
city: Lisboa
country: Portugal
facility: CHLN, EPE - Hospital de Santa Maria
city: Porto
country: Portugal
facility: IPO Porto Francisco Gentil, EPE
city: Porto
country: Portugal
facility: Centro Hospitalar São João,EPE
city: Setúbal
country: Portugal
facility: CHS, EPE - Hospital de São Bernardo
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia
city: Baia Mare
country: Romania
facility: Baia Mare Emergency County Hospital
city: Brasov
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Brasov
city: Bucuresti
country: Romania
facility: Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta"
city: Hunedoara
country: Romania
facility: County Hospital "Dr. Alex Simionescu"
city: Iasi
country: Romania
facility: Centrul de Oncologie Medicala
city: Iasi
country: Romania
facility: Emergency Clinical County Hospital "Sf Spiridon", Iasi
city: Onesti
country: Romania
facility: Onesti County Hospital
city: Suceava
country: Romania
facility: Emergency County Hospital "Sf.loan cel Nou"
city: Timisoara
country: Romania
facility: Oncomed SRL
city: Arkhangelsk
country: Russian Federation
facility: SBIH of Arkhangelsk reg. "Arkhangelsk Clin. Onc. Dispensary"
city: Chelyabinsk
country: Russian Federation
facility: GLPU Cheliabinsky
city: Irkutsk
country: Russian Federation
facility: GUZ Irkutsk Regional Oncology Dispensary
city: Kazan
country: Russian Federation
facility: St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
city: Kursk
country: Russian Federation
facility: RBIH "Kursk regional clinical oncology dispensary"
city: Magnitogorsk
country: Russian Federation
facility: GUZ Regional Oncology Dispensary, Magnitogorsk
city: Moscow
country: Russian Federation
facility: FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
city: Pyatigorsk
country: Russian Federation
facility: SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary"
city: Ryazan
country: Russian Federation
facility: GUZ "Regional Clinical Oncology Dispensary"
city: Sochi
country: Russian Federation
facility: GUZ "Oncological Dispesary #2"
city: St. Petersburg
country: Russian Federation
facility: GUZ Leningradskaya Regional Clin. Hospital, St. Petersburg
city: St. Petersburg
country: Russian Federation
facility: 1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
city: St. Petersburg
country: Russian Federation
facility: SPb SBIH "City Clinical Oncological Dispensary"
city: St. Petersburg
country: Russian Federation
facility: FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF
city: Yekaterinburg
country: Russian Federation
facility: GUZ Sverdlovsky Regional Oncology Dispensary
city: Trnava
country: Slovakia
facility: Faculty Hospital Trnava
city: Cape Town
country: South Africa
facility: GVI oncology Medi Clinic
city: Durban
country: South Africa
facility: Parklands Hospital
city: Johannesburg
country: South Africa
facility: WCR CMJAH Clinical Trial Site
city: Johannesburg
country: South Africa
facility: Medical Oncology Centre of Rosebank
city: Port Elizabeth
country: South Africa
facility: Langenhoven Drive Oncology Centre
city: Pretoria
country: South Africa
facility: Pretoria Academic Hospital
city: Pretoria
country: South Africa
facility: Wilgers oncology
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Elche
country: Spain
facility: Hospital Universitario de Elche
city: Jerez De La Frontera-Cádiz
country: Spain
facility: Hospital Jerez de la Frontera
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quirónsalud Madrid
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncologia
city: Valencia
country: Spain
facility: Servicio de Oncologia Radiotherapica
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Baden
country: Switzerland
facility: Kantonsspital Baden AG
city: Chernigiv
country: Ukraine
facility: Chernigiv Regional Oncology Centre
city: Chernivtsi
country: Ukraine
facility: Bukovynsk State Medical University
city: Chmelnytskyi
country: Ukraine
facility: Chmelnytskyi Oblasnnyi Oncologichnyi Tsentr
city: Dnipropetrovsk
country: Ukraine
facility: City Clinical Hospital #4, Dnipropetrovsk State Medical Academy
city: Donetsk
country: Ukraine
facility: Donetsk Regional Antitumor Centre
city: Kharkiv
country: Ukraine
facility: Kharkiv Medical Acadamy of Postgraduate education
city: Kryvyi Rig
country: Ukraine
facility: Kryvorizskyi regional communal clinical oncology centre
city: Odesa
country: Ukraine
facility: Odesa Regional Oncological Centre
city: Ternopil
country: Ukraine
facility: Ternopil regional communal clinical oncology centre
city: Uzhgorod
country: Ukraine
facility: Uzhgorod National University, Oncology Centre
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Oncological Dispensary
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth and Christchurch Hospital
city: Bristol
country: United Kingdom
facility: Bristol Haematology & Onc. Ctr
city: Chelmsford
country: United Kingdom
facility: Broomfield Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Poole
country: United Kingdom
facility: Poole Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.