A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
NCT ID: NCT03033511
Last Updated: 2021-07-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
748 participants
INTERVENTIONAL
2017-02-07
2019-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rovalpituzumab tesirine/dexamethasone
Rovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle
Rovalpituzumab tesirine
Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Dexamethasone
Dexamethasone 8 mg administered orally (PO) twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
Placebo
Placebo q6 wk; omitting every third cycle
Placebo for dexamethasone
Placebo for dexamethasone PO twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
Placebo for rovalpituzumab tesirine
Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Interventions
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Placebo for dexamethasone
Placebo for dexamethasone PO twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
Placebo for rovalpituzumab tesirine
Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Rovalpituzumab tesirine
Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Dexamethasone
Dexamethasone 8 mg administered orally (PO) twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
Eligibility Criteria
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Inclusion Criteria
* Participant is eligible to be randomized at least 3 but no more than 9 weeks from Day 1 of the fourth cycle of first-line platinum-based chemotherapy.
* Participants with a history of central nervous system (CNS) metastases prior to the initiation of first-line platinum-based chemotherapy must have received definitive local treatment and have documentation of stable or improved CNS disease status
* Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
* Participants must have adequate bone marrow, renal and hepatic function
* Availability of archived or representative tumor material for assessment of DLL3 expression
* Any disease-directed radiotherapy (except prophylactic cranial irradiation, palliative radiotherapy to a radiographically documented non-progressing lesion for symptom control, or pre-planned radiotherapy for CNS metastases present prior to start of first-line therapy and non-progressing) after last dose of first-line chemotherapy.
* Prior exposure to a pyrrolobenzodiazepine (PBD-based) or indolinobenzodiazepine-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient contained in the drug formulation.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Clearview Cancer Institute /ID# 156699
Huntsville, Alabama, United States
University of South Alabama /ID# 160975
Mobile, Alabama, United States
Highlands Oncology Group /ID# 156722
Fayetteville, Arkansas, United States
Marin Cancer Care /ID# 159207
Greenbrae, California, United States
Ucsd /Id# 157764
La Jolla, California, United States
LA Hem-Oncology Med Group /ID# 156717
Los Angeles, California, United States
Palo Alto Veterans Institute for Research /ID# 203695
Palo Alto, California, United States
St Jude Hospital dba St Joseph /ID# 156526
Santa Rosa, California, United States
Icri /Id# 157765
Whittier, California, United States
Kaiser Permanente Lone Tree /ID# 159331
Lone Tree, Colorado, United States
Christiana Care Health Service /ID# 159212
Newark, Delaware, United States
Holy Cross Hospital /ID# 156716
Fort Lauderdale, Florida, United States
University of Florida - Archer /ID# 155799
Gainesville, Florida, United States
Memorial Cancer Institute /ID# 156673
Hollywood, Florida, United States
Memorial Cancer Institute /ID# 164052
Hollywood, Florida, United States
Cancer Specialists of North Florida - Southpoint /ID# 156595
Jacksonville, Florida, United States
Georgia Cancer Center /ID# 201894
Atlanta, Georgia, United States
Southeastern Regional Medical /ID# 163064
Newnan, Georgia, United States
St. Luke's Mountain States Tumor Institute - Boise /ID# 156691
Boise, Idaho, United States
NorthShore University HealthSystem - Evanston Hospital /ID# 156664
Evanston, Illinois, United States
Ingalls Memorial Hosp /ID# 156685
Harvey, Illinois, United States
Goshen Center for Cancer Care /ID# 156682
Goshen, Indiana, United States
Ashland-Bellefonte Cancer Ctr /ID# 202901
Ashland, Kentucky, United States
University of Louisville /ID# 156683
Louisville, Kentucky, United States
Ochsner Clinic Foundation /ID# 159136
Baton Rouge, Louisiana, United States
Henry Ford Health System /ID# 156712
Detroit, Michigan, United States
Sparrow Regional Cancer Center, Sparrow Health System /ID# 156590
Lansing, Michigan, United States
Mayo Clinic - Rochester /ID# 160181
Rochester, Minnesota, United States
MidAmerica Division, Inc. /ID# 163530
Kansas City, Missouri, United States
Billings Clinic /ID# 201788
Billings, Montana, United States
Nebraska Hematology Oncology /ID# 156534
Lincoln, Nebraska, United States
MD Anderson Cancer Center at Cooper - Camden /ID# 156681
Camden, New Jersey, United States
Northwell Health - Monter Cancer Center /ID# 159252
Lake Success, New York, United States
Icahn School of Med Mt. Sinai /ID# 159210
New York, New York, United States
Stony Brook University Hospital /ID# 159272
Stony Brook, New York, United States
Montefiore Medical Center /ID# 201845
The Bronx, New York, United States
Duke University Medical Center /ID# 156706
Durham, North Carolina, United States
Cone Health /ID# 156689
Greensboro, North Carolina, United States
Cone Health /ID# 163612
Greensboro, North Carolina, United States
Eastern Carolina University /ID# 159264
Greenville, North Carolina, United States
Gabrail Cancer Center Research /ID# 156667
Canton, Ohio, United States
Kaiser Permanente, NW /ID# 201793
Portland, Oregon, United States
Thomas Jefferson University /ID# 156719
Philadelphia, Pennsylvania, United States
VA Pittsburgh HealthcareSystem /ID# 159284
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital /ID# 160834
Providence, Rhode Island, United States
Sarah Cannon Research Institute-Chattanooga /ID# 202933
Chattanooga, Tennessee, United States
Thompson Cancer Survival Ctr /ID# 202460
Knoxville, Tennessee, United States
Tennessee Oncology-Nashville Centennial /ID# 161168
Nashville, Tennessee, United States
Univ Medical Ctr Brackenridge /ID# 155798
Austin, Texas, United States
Parkland Health and Hosp Syste /ID# 170933
Dallas, Texas, United States
UT Southwestern Medical Center /ID# 157848
Dallas, Texas, United States
Houston Methodist Hospital - Scurlock Tower /ID# 202323
Houston, Texas, United States
Medical Oncology Associates /ID# 156715
Spokane, Washington, United States
West Virginia Univ School Med /ID# 156687
Morgantown, West Virginia, United States
Coffs Harbour Hospital /ID# 158880
Coffs Harbour, New South Wales, Australia
Gosford Hospital /ID# 158884
Gosford, New South Wales, Australia
Newcastle Private Hospital /ID# 203506
Lambton Heights, New South Wales, Australia
Royal North Shore Hospital /ID# 158881
Saint Leonards, New South Wales, Australia
Calvary North Adelaide Hospita /ID# 161701
Adelaide, South Australia, Australia
Sunshine Hospital /ID# 161700
St Albans, Victoria, Australia
Affinity Clinical Research Ser /ID# 158887
Nedlands, , Australia
SMZ Baumgartner Höhe, Otto-Wagner-Spital und Pflegezentrum /ID# 201776
Vienna, Vienna, Austria
Krankenhaus Nord - Klinik Floridsdorf /ID# 201768
Vienna, Vienna, Austria
LKH-Univ. Klinikum Graz /ID# 159563
Graz, , Austria
Ordensklinikum Linz GmbH, Elisabethinen /ID# 159564
Linz, , Austria
Salzburger Landeskliniken (SALK) /ID# 201779
Salzburg, , Austria
Bobruysk Interdistrict Onco. /ID# 169393
Babruysk, , Belarus
State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159383
Lesnoy, , Belarus
Mogilev Reg Clin Oncology Dis /ID# 159384
Mogilev, , Belarus
CHU Saint-Pierre /ID# 159009
Brussels, Brussels Capital, Belgium
Grand Hôpital de Charleroi /ID# 159006
Charleroi, Hainaut, Belgium
ZNA Middelheim /ID# 159007
Antwerp, , Belgium
Hopital de Jolimont /ID# 159005
Haine-Saint-Paul, , Belgium
CHU Charleroi (Vesale) /ID# 159008
Montigny-le-Tilleul, , Belgium
Hospital Evangelico de Cachoei /ID# 159657
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Liga Norte Rio Grandense Cont. /ID# 159011
Natal, Rio Grande do Norte, Brazil
Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 159013
Ijuí, Rio Grande do Sul, Brazil
Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159661
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Sao Lucas da PUCRS /ID# 159662
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159012
Barretos, São Paulo, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159659
São José do Rio Preto, São Paulo, Brazil
Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159658
Rio de Janeiro, , Brazil
UMHAT Tsaritsa Joanna - ISUL /ID# 159638
Sofia, , Bulgaria
UMHAT Sv. Ivan Rilski /ID# 159639
Sofia, , Bulgaria
British Columbia Cancer Agency /ID# 163721
Surrey, British Columbia, Canada
Brampton Civic Hospital /ID# 204425
Brampton, Ontario, Canada
R.S. McLaughlin Durham Regional /ID# 170870
Oshawa, Ontario, Canada
Princess Margaret /ID# 170868
Toronto, Ontario, Canada
Windsor Regional Cancer Centre /ID# 170869
Windsor, Ontario, Canada
Iucpq-Ul /Id# 159530
Québec, Quebec, Canada
Fujian Provincial Cancer Hospital /ID# 204864
Fuzhou, Fujian, China
Harbin Medical University Cancer Hospital /Id# 203638
Harbin, Heilongjiang, China
Hubei Cancer Hospital /ID# 202886
Wuhan, Hubei, China
Jilin Cancer Hosptial /ID# 204060
Changchun, Jilin, China
The Affiliated Cancer Hospital of Xinjiang Medical university /ID# 203641
Ürümqi, Xinjiang, China
Yunnan Cancer Hospital /ID# 204911
Kunming, Yunnan, China
Zhejiang Cancer hospital /ID# 204640
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital /ID# 206802
Jianggan Hangzhou, Zhejiang, China
Jiangsu Province Hospital /ID# 205183
Nanjing, , China
4th Military Medical Universit /ID# 203986
Xi'an, , China
First Affiliated Hospital of Xi'an Jiaotong University /ID# 203733
Xi'an, , China
Henan Cancer Hospital /ID# 203983
Zhengzhou Henan, , China
Henan Cancer Hospital /ID# 204636
Zhengzhou Henan, , China
Klinicki bolnicki centar Sestre milosrdnice /ID# 159090
Zagreb, City of Zagreb, Croatia
Klinika za plucne bolesti Jordanovac /ID# 159505
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Rijeka /ID# 159504
Rijeka, Primorje-Gorski Kotar County, Croatia
Thomayerova nemocnice /ID# 159062
Prague, Praha 4, Czechia
Nemocnice Rudolfa a Stefanie /ID# 159655
Benešov, , Czechia
Nemocnice Horovice a.s. /ID# 161186
Hořovice, , Czechia
Vitkovicka nemocnice a. s. /ID# 161187
Ostrava, , Czechia
FN Plzen /ID# 204097
Pilsen, , Czechia
Oblastni Nemocnice Pribram /ID# 159654
Příbram, , Czechia
Rigshospitalet /ID# 158055
Copenhagen Ø, Capital Region, Denmark
Herlev Hospital /ID# 158053
Herlev, Capital Region, Denmark
Aalborg University Hospital /ID# 203737
Aalborg, North Denmark, Denmark
Odense Universitets Hospital /ID# 158054
Odense C, Region Syddanmark, Denmark
East Tallinn Central Hospital /ID# 160019
Tallinn, , Estonia
North Estonian Medical Centre /ID# 159779
Tallinn, , Estonia
Docrates Cancer Center /ID# 159591
Helsinki, , Finland
CHU Hopital Nord /ID# 160543
Marseille, Bouches-du-Rhone, France
Hopital Haut-Lévêque /ID# 160547
Pessac, Gironde, France
CHU Calmette /ID# 202706
Lille, Hauts-de-France, France
Centre Leon Berard /ID# 160550
Lyon, Rhone, France
Centre Hosp Intercommunal de Creteil /ID# 162686
Créteil, Val-de-Marne, France
Hopital Tenon /ID# 160541
Paris, , France
Hospital Pontchaillou /ID# 160544
Rennes, , France
Nouvel Hopital Civil (NHC) /ID# 204427
Strasbourg, , France
Hopital Larrey /ID# 204290
Toulouse, , France
Institut Curie /ID# 207514
Paris, Île-de-France Region, France
KH Martha-Maria Halle Dolau /ID# 158794
Halle, Saxony-Anhalt, Germany
Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 158783
Berlin, , Germany
Evangelische Lungenklinik Berl /ID# 158935
Berlin, , Germany
Asklepios Fachkliniken M. Gaut /ID# 158789
Gauting, , Germany
Thoraxklinik Heidelberg gGmbH /ID# 158871
Heidelberg, , Germany
Lungenklinik Hemer /ID# 158790
Hemer, , Germany
Klinikum Kassel /ID# 158786
Kassel, , Germany
Klinik Loewenstein GmbH /ID# 158870
Löwenstein, , Germany
Fachkliniken Wangen /ID# 160779
Wangen, , Germany
Metropolitan General Hospital /ID# 202422
Cholargós, Attica, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159160
Athens, , Greece
Metropolitan Hospital /ID# 159157
Athens, , Greece
University General Hospital of Heraklion PA.G.N.I /ID# 202409
Heraklion, , Greece
University Hospital of Ioannin /ID# 159158
Ioannina, , Greece
General Oncological Hospital /ID# 159159
Nea Kifissia, , Greece
Euromedica General Clinic /ID# 159156
Thessaloniki, , Greece
Queen Elizabeth Hospital /ID# 159565
Kowloon, , Hong Kong
Princess Margaret Hospital /ID# 162810
Lai Chi Kok, , Hong Kong
Tuen Mun Hospital /ID# 162435
Tuenmen, , Hong Kong
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 158962
Miskolc, Borsod-Abauj Zemplen county, Hungary
Orszagos Koranyi Pulmonologiai Intezet /ID# 158953
Budapest XII, Budapest, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz - Pulmonologia /ID# 202466
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Semmelweis Egyetem /ID# 158955
Budapest, , Hungary
Csongrad Megyei Mellkasi Beteg /ID# 158952
Deszk, , Hungary
St. James's Hospital /ID# 159712
Dublin, Dublin, Ireland
Cork University Hospital /ID# 159715
Cork, , Ireland
St Vincent's University Hosp /ID# 161678
Dublin, , Ireland
Beaumont Hospital /ID# 159711
Dublin, , Ireland
University Hospital Limerick /ID# 159714
Limerick, , Ireland
University Hospital Waterford /ID# 159713
Waterford, , Ireland
Rabin Medical Center /ID# 159764
Petakh Tikva, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 161467
Tel Aviv, Tel Aviv, Israel
Soroka University Medical Center /ID# 159762
Beersheba, , Israel
Assaf Harofeh Medical Center /ID# 201883
Be’er Ya‘aqov, , Israel
Rambam Health Care Campus /ID# 202336
Haifa, , Israel
Hadassah /ID# 159763
Jerusalem, , Israel
Meir Medical Center /ID# 159761
Kfar Saba, , Israel
Sheba Medical Center /ID# 159760
Ramat Gan, , Israel
IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 160898
Meldola, Emilia-Romagna, Italy
Policlinico Universitario Campus Bio-Medico /ID# 160874
Rome, Lazio, Italy
AUSL 8 Arezzo Ospedale San Don /ID# 160897
Arezzo, , Italy
A.O.U. San Luigi Gonzaga /ID# 158916
Orbassano, , Italy
Ospedale Santa Maria delle Cro /ID# 158911
Ravenna, , Italy
IFO Istituto Nazionale Tumori /ID# 158912
Rome, , Italy
Aichi Cancer Center Hospital /ID# 164976
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 165721
Kashiwa-shi, Chiba, Japan
Kyushu University Hospital /ID# 165722
Fukuoka, Fukuoka, Japan
Kurume University Hospital /ID# 164595
Kurume-shi, Fukuoka, Japan
Kanazawa University Hospital /ID# 165127
Kanazawa, Ishikawa-ken, Japan
Kanagawa Cardiovascular and Respiratory Center /ID# 165015
Yokohama, Kanagawa, Japan
Yokohama City University Hospital /ID# 165746
Yokohama, Kanagawa, Japan
Japanese Red Cross Okayama Hospital /ID# 165157
Okayama, Okayama-ken, Japan
Kansai Medical University Hospital /ID# 165054
Hirakata-shi, Osaka, Japan
Kindai University Hospital /ID# 166395
Osaka-sayama-shi, Osaka, Japan
Shizuoka Cancer Center /ID# 166272
Sunto-gun, Shizuoka, Japan
Tokushima University Hospital /ID# 166105
Tokushima, Tokushima, Japan
National Cancer Center Hospital /ID# 166547
Chuo-ku, Tokyo, Japan
Showa University Hospital /ID# 165575
Shinagawa-ku, Tokyo, Japan
Wakayama Medical University /ID# 165946
Wakayama, Wakayama, Japan
Hyogo Cancer Center /ID# 165138
Akashi, , Japan
National Hospital Organization Himeji Medical Center /ID# 165899
Himeji, , Japan
Matsusaka City Hospital /ID# 166156
Matsusaka-shi MIE, , Japan
Osaka City General Hospital /ID# 165714
Osaka, , Japan
Hokkaido Cancer Center /ID# 165236
Sapporo, , Japan
Sendai Kousei Hospital /ID# 166491
Sendai, , Japan
Kanagawa Cancer Center /ID# 165814
Yokohama, , Japan
Pauls Stradins Clinical /ID# 158715
Riga, , Latvia
Riga East Clinical University /ID# 158716
Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 160016
Kaunas, Kaunas County, Lithuania
Klaipeda University Hospital /ID# 160018
Klaipėda, , Lithuania
National Cancer Institute /ID# 160017
Vilnius, , Lithuania
Centro de Investigación Clinica Chapultepec /ID# 160965
Morelia, Michoacán, Mexico
Health Pharma professional Ser /ID# 160734
Mexico City, , Mexico
Jeroen Bosch Ziekenhuis /ID# 158081
's-Hertogenbosch, , Netherlands
Meander Medisch Centrum /ID# 159064
Amersfoort, , Netherlands
Rijnstate /ID# 159063
Arnhem, , Netherlands
Amphia Ziekenhuis /ID# 159065
Breda, , Netherlands
Catharina Ziekenhuis /ID# 158082
Eindhoven, , Netherlands
Maastricht Universitair Medisch Centrum /ID# 161669
Maastricht, , Netherlands
Universitair Medisch Centrum Utrecht /ID# 158083
Utrecht, , Netherlands
Akershus universitetssykehus /ID# 201682
Nordbyhagen, Akershus, Norway
Drammen Sykehus /ID# 159572
Drammen, Buskerud, Norway
Haukeland University Hospital /ID# 159573
Bergen, Hordaland, Norway
St. Olavs Hospital HF /ID# 163110
Trondheim, Sor-Trondelag, Norway
Radiumhospitalet, OUS /ID# 159574
Oslo, , Norway
Stavanger Universitetssykehus /ID# 159575
Stavanger, , Norway
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 159604
Rzeszów, Podkarpackie Voivodeship, Poland
Wojewodzki Szpital Specjalisty /ID# 159603
Bytom, , Poland
Szpitale Pomorskie Sp. z o.o /ID# 159605
Gdynia, , Poland
Centro Hospitalar Lisboa Norte, EPE /ID# 159957
Lisbon, Lisbon District, Portugal
IPO Lisboa FG, EPE /ID# 159949
Lisbon, , Portugal
Hospital da Luz, SA /ID# 159954
Lisbon, , Portugal
Unidade Local Saude Matosinhos /ID# 159950
Matosinhos Municipality, , Portugal
Centro Hospitalar do Porto EPE /ID# 203582
Porto, , Portugal
Hospital CUF Porto /ID# 159955
Porto, , Portugal
IPO Porto FG, EPE /ID# 159956
Porto, , Portugal
National Medical Research Cntr /ID# 169885
Moscow, Moscow Oblast, Russia
Arkhangelsk clinical oncology /ID# 159367
Arkhangelsk, , Russia
Kaluga Regional Clinical Oncol /ID# 160180
Kaluga, , Russia
Clinical Onco Dispensary /ID# 159365
Omsk, , Russia
PMI Euromedservice /ID# 159369
Pushkin, , Russia
LLC Novaya Clinica /ID# 205523
Pyatigorsk, , Russia
LLC BioEq Ltd. /ID# 159368
Saint Petersburg, , Russia
OOO Centre of Palliative Medicine De Vita /ID# 206855
Saint Petersburg, , Russia
N.N. Petrov Research Inst Onc /ID# 159370
Saint Petersburg, , Russia
Ogarev Mordovia State Univ /ID# 205742
Saransk, , Russia
Smolensk Regional Onc Clin Dis /ID# 159372
Smolensk, , Russia
Clinical Center Serbia /ID# 160902
Belgrade, Beograd, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 160903
Belgrade, Beograd, Serbia
Clinical Center of Nis /ID# 160905
Niš, Nisavski Okrug, Serbia
Institut za onkologiju i radio /ID# 160904
Belgrade, , Serbia
Institute For Pulmonary Diseas /ID# 164250
Kamenitz, , Serbia
Cancercare Langenhoven Drive Oncology Centre /ID# 159126
Port Elizabeth, Eastern Cape, South Africa
Dr Albert, Bouwer and Jordaan Incorporated /ID# 158873
Pretoria, Gauteng, South Africa
Mary Potter Oncology Centre /ID# 158877
Pretoria, Gauteng, South Africa
The Oncology Centre /ID# 158872
Durban, KwaZulu-Natal, South Africa
Cape Town Oncology Trials /ID# 201311
Cape Town, Western Cape, South Africa
Cancercare Outeniqua Oncology Unit /ID# 200689
George, Western Cape, South Africa
Dong-A University Hospital /ID# 159305
Busan, Busan Gwang Yeogsi, South Korea
CHA Bundang Medical center CHA University /ID# 161281
Seongnam-si, Gyeonggido, South Korea
Kyungpook National University Chilgok Hospital /ID# 159301
Daegu, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 159304
Seoul, Seoul Teugbyeolsi, South Korea
Korea University Guro Hospital /ID# 159302
Seoul, Seoul Teugbyeolsi, South Korea
Chungbuk National University /ID# 159300
Cheongju-si, , South Korea
Severance Hospital /ID# 159297
Seoul, , South Korea
Asan Medical Center /ID# 159299
Seoul, , South Korea
Hospital Teresa Herrera - CHUAC /ID# 164368
A Coruña, A Coruna, Spain
Hospital Regional de Malaga /ID# 164371
Málaga, Malaga, Spain
Hospital Parc de Salut del Mar /ID# 159690
Barcelona, , Spain
Hospital Universitario Vall d'Hebron /ID# 159708
Barcelona, , Spain
Hospital Clinico Universitario San Carlos /ID# 159706
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 159693
Madrid, , Spain
Hospital Universitario La Paz /ID# 159692
Madrid, , Spain
Hospital Clinico Universitario Lozano Blesa /ID# 159709
Zaragoza, , Spain
Centralsjukhuset, Karlstad /ID# 163451
Karlstad, Värmland County, Sweden
Sahlgrenska US Gbg /ID# 159524
Gothenburg, Västra Götaland County, Sweden
University Hospital Linkoping /ID# 159046
Linköping, , Sweden
Karolinska Univ Sjukhuset /ID# 159649
Solna, , Sweden
Uppsala University Hospital /ID# 159052
Uppsala, , Sweden
Hopitaux Universitaires de Geneve /ID# 160603
Geneva, Canton of Geneva, Switzerland
Kantonsspital St. Gallen /ID# 160604
Sankt Gallen, Canton of St. Gallen, Switzerland
Universitaetsspital Basel /ID# 160605
Basel, , Switzerland
Luzerner Kantonsspital /ID# 160607
Lucerne, , Switzerland
Kantonsspital Winterthur /ID# 161379
Winterthur, , Switzerland
China Medical University Hosp /ID# 158981
Taichung, Taichung, Taiwan
National Cheng Kung University Hospital /ID# 158799
Tainan City, Tainan, Taiwan
National Taiwan Univ Hosp /ID# 159049
Taipei City, Taipei, Taiwan
Tri-Service General Hospital /ID# 158980
Taipei City, Taipei, Taiwan
Dalin Tzu Chi General Hospital /ID# 158983
Dalin Township, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 158798
Kaohsiung City, , Taiwan
Taichung Veterans General Hosp /ID# 159047
Taichung, , Taiwan
Taipei Veterans General Hosp /ID# 203699
Taipei, , Taiwan
Hacettepe University Medical Faculty /ID# 159242
Altindağ, Ankara, Turkey (Türkiye)
Erciyes University Medical Fac /ID# 202269
Melikgazi, Kayseri, Turkey (Türkiye)
Ataturk Gogus Hastalikl /ID# 159556
Ankara, , Turkey (Türkiye)
Akdeniz Universitesi Tip Fakul /ID# 160791
Antalya, , Turkey (Türkiye)
Bezmi alem Vakif Universitesi /ID# 202267
Istanbul, , Turkey (Türkiye)
Istanbul Medeniyet Universites /ID# 200126
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty /ID# 159243
Izmir, , Turkey (Türkiye)
Dr. Suat Seren Gogus Has /ID# 159244
Izmir, , Turkey (Türkiye)
Inonu University /ID# 159245
Malatya, , Turkey (Türkiye)
CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159131
Zaporizhzhia, Zaporizhzhia Oblast, Ukraine
Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 159864
Chernivtsi, , Ukraine
Municipal institution Multifie /ID# 159130
Dnipro, , Ukraine
Regional Center of Oncology /ID# 159132
Kharkiv, , Ukraine
PE PMC Acinus, Medical and Diagnostic Center /ID# 165543
Kropyvnytskyi, , Ukraine
Volyn Regional Medical Oncology Centre /ID# 159133
Lutsk, , Ukraine
Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159865
Uzhhorod, , Ukraine
Cheltenham General Hospital /ID# 169096
Cheltenham, Gloucestershire, United Kingdom
Queen Elizabeth Medical Centre /ID# 162899
Birmingham, , United Kingdom
The Royal Bournemouth Hospital /ID# 159039
Bournemouth, , United Kingdom
Colchester General Hospital /ID# 159042
Colchester, , United Kingdom
Hereford County Hospital /ID# 159038
Hereford, , United Kingdom
St. George's Healthcare NHS /ID# 202416
London, , United Kingdom
Charing Cross Hospital /ID# 161399
London, , United Kingdom
Maidstone Hospital /ID# 159043
Maidstone, , United Kingdom
Christie NHS Foundation Trust /ID# 159037
Manchester, , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 159044
Newcastle upon Tyne, , United Kingdom
Torbay Hospital - So Devon HC /ID# 159041
Torquay, , United Kingdom
Countries
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References
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Tanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2016-003503-64
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-298
Identifier Type: -
Identifier Source: org_study_id
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