Study Stopped
Independent Data Monitoring Committee recommendation
A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
MERU
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)
2 other identifiers
interventional
748
37 countries
287
Brief Summary
This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2017
Typical duration for phase_3
287 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2017
CompletedFirst Posted
Study publicly available on registry
January 26, 2017
CompletedStudy Start
First participant enrolled
February 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2019
CompletedResults Posted
Study results publicly available
December 21, 2020
CompletedJuly 29, 2021
July 1, 2021
2.8 years
January 25, 2017
November 11, 2020
July 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
Survival follow-up continued until the endpoint of death, participant was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.
Secondary Outcomes (2)
OS in All Randomized Participants
Survival follow-up continued until the endpoint of death, the subject was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)
Study Arms (2)
Rovalpituzumab tesirine/dexamethasone
EXPERIMENTALRovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle
Placebo
EXPERIMENTALPlacebo q6 wk; omitting every third cycle
Interventions
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 administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
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
You may qualify if:
- Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC) at initial diagnosis with ongoing clinical benefit (stable disease \[SD\], partial response \[PR\], or complete response \[CR\]) following completion of 4 cycles of first-line platinum-based therapy
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (308)
Clearview Cancer Institute /ID# 156699
Huntsville, Alabama, 35805, United States
University of South Alabama /ID# 160975
Mobile, Alabama, 36604-3302, United States
Highlands Oncology Group /ID# 156722
Fayetteville, Arkansas, 72703-4005, United States
Marin Cancer Care /ID# 159207
Greenbrae, California, 94904, United States
Ucsd /Id# 157764
La Jolla, California, 92093, United States
LA Hem-Oncology Med Group /ID# 156717
Los Angeles, California, 90017, United States
Palo Alto Veterans Institute for Research /ID# 203695
Palo Alto, California, 94304-1207, United States
St Jude Hospital dba St Joseph /ID# 156526
Santa Rosa, California, 95403, United States
Icri /Id# 157765
Whittier, California, 90603, United States
Kaiser Permanente Lone Tree /ID# 159331
Lone Tree, Colorado, 80124, United States
Christiana Care Health Service /ID# 159212
Newark, Delaware, 19713, United States
Holy Cross Hospital /ID# 156716
Fort Lauderdale, Florida, 33308, United States
University of Florida - Archer /ID# 155799
Gainesville, Florida, 32610, United States
Memorial Cancer Institute /ID# 156673
Hollywood, Florida, 33021-5421, United States
Memorial Cancer Institute /ID# 164052
Hollywood, Florida, 33021-5421, United States
Cancer Specialists of North Florida - Southpoint /ID# 156595
Jacksonville, Florida, 32256, United States
Georgia Cancer Center /ID# 201894
Atlanta, Georgia, 30342, United States
Southeastern Regional Medical /ID# 163064
Newnan, Georgia, 30265, United States
St. Luke's Mountain States Tumor Institute - Boise /ID# 156691
Boise, Idaho, 83712, United States
NorthShore University HealthSystem - Evanston Hospital /ID# 156664
Evanston, Illinois, 60201, United States
Ingalls Memorial Hosp /ID# 156685
Harvey, Illinois, 60426, United States
Goshen Center for Cancer Care /ID# 156682
Goshen, Indiana, 46526, United States
Ashland-Bellefonte Cancer Ctr /ID# 202901
Ashland, Kentucky, 41101, United States
University of Louisville /ID# 156683
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation /ID# 159136
Baton Rouge, Louisiana, 70836-6455, United States
Henry Ford Health System /ID# 156712
Detroit, Michigan, 48202, United States
Sparrow Regional Cancer Center, Sparrow Health System /ID# 156590
Lansing, Michigan, 48912, United States
Mayo Clinic - Rochester /ID# 160181
Rochester, Minnesota, 55905-0001, United States
MidAmerica Division, Inc. /ID# 163530
Kansas City, Missouri, 64132, United States
Billings Clinic /ID# 201788
Billings, Montana, 59101-0733, United States
Nebraska Hematology Oncology /ID# 156534
Lincoln, Nebraska, 68506, United States
MD Anderson Cancer Center at Cooper - Camden /ID# 156681
Camden, New Jersey, 08103, United States
Northwell Health - Monter Cancer Center /ID# 159252
Lake Success, New York, 11042, United States
Icahn School of Med Mt. Sinai /ID# 159210
New York, New York, 10029, United States
Stony Brook University Hospital /ID# 159272
Stony Brook, New York, 11794-8183, United States
Montefiore Medical Center /ID# 201845
The Bronx, New York, 10461, United States
Duke University Medical Center /ID# 156706
Durham, North Carolina, 27710-3000, United States
Cone Health /ID# 156689
Greensboro, North Carolina, 27403, United States
Cone Health /ID# 163612
Greensboro, North Carolina, 27403, United States
Eastern Carolina University /ID# 159264
Greenville, North Carolina, 27834, United States
Gabrail Cancer Center Research /ID# 156667
Canton, Ohio, 44718, United States
Kaiser Permanente, NW /ID# 201793
Portland, Oregon, 97227, United States
Thomas Jefferson University /ID# 156719
Philadelphia, Pennsylvania, 19107-4414, United States
VA Pittsburgh HealthcareSystem /ID# 159284
Pittsburgh, Pennsylvania, 15240, United States
Rhode Island Hospital /ID# 160834
Providence, Rhode Island, 02903, United States
Sarah Cannon Research Institute-Chattanooga /ID# 202933
Chattanooga, Tennessee, 37404-1108, United States
Thompson Cancer Survival Ctr /ID# 202460
Knoxville, Tennessee, 37916, United States
Tennessee Oncology-Nashville Centennial /ID# 161168
Nashville, Tennessee, 37203-1632, United States
Univ Medical Ctr Brackenridge /ID# 155798
Austin, Texas, 78701, United States
Parkland Health and Hosp Syste /ID# 170933
Dallas, Texas, 75235, United States
UT Southwestern Medical Center /ID# 157848
Dallas, Texas, 75390-7208, United States
Houston Methodist Hospital - Scurlock Tower /ID# 202323
Houston, Texas, 77030, United States
Medical Oncology Associates /ID# 156715
Spokane, Washington, 99208, United States
West Virginia Univ School Med /ID# 156687
Morgantown, West Virginia, 26506, United States
Coffs Harbour Hospital /ID# 158880
Coffs Harbour, New South Wales, 2450, Australia
Gosford Hospital /ID# 158884
Gosford, New South Wales, 2250, Australia
Newcastle Private Hospital /ID# 203506
Lambton Heights, New South Wales, 2305, Australia
Royal North Shore Hospital /ID# 158881
Saint Leonards, New South Wales, 2065, Australia
Calvary North Adelaide Hospita /ID# 161701
Adelaide, South Australia, 5006, Australia
Sunshine Hospital /ID# 161700
St Albans, Victoria, 3021, Australia
Affinity Clinical Research Ser /ID# 158887
Nedlands, 6009, Australia
SMZ Baumgartner Höhe, Otto-Wagner-Spital und Pflegezentrum /ID# 201776
Vienna, Vienna, 1140, Austria
Krankenhaus Nord - Klinik Floridsdorf /ID# 201768
Vienna, Vienna, 1210, Austria
LKH-Univ. Klinikum Graz /ID# 159563
Graz, 8036, Austria
Ordensklinikum Linz GmbH, Elisabethinen /ID# 159564
Linz, 4020, Austria
Salzburger Landeskliniken (SALK) /ID# 201779
Salzburg, 5020, Austria
Bobruysk Interdistrict Onco. /ID# 169393
Babruysk, 213825, Belarus
State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159383
Lesnoy, 223040, Belarus
Mogilev Reg Clin Oncology Dis /ID# 159384
Mogilev, 212018, Belarus
CHU Saint-Pierre /ID# 159009
Brussels, Brussels Capital, 1000, Belgium
Grand Hôpital de Charleroi /ID# 159006
Charleroi, Hainaut, 6000, Belgium
ZNA Middelheim /ID# 159007
Antwerp, 2020, Belgium
Hopital de Jolimont /ID# 159005
Haine-Saint-Paul, 7100, Belgium
CHU Charleroi (Vesale) /ID# 159008
Montigny-le-Tilleul, 6110, Belgium
Hospital Evangelico de Cachoei /ID# 159657
Cachoeiro de Itapemirim, Espírito Santo, 29308-020, Brazil
Liga Norte Rio Grandense Cont. /ID# 159011
Natal, Rio Grande do Norte, 59075-740, Brazil
Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 159013
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159661
Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
Hospital Sao Lucas da PUCRS /ID# 159662
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159012
Barretos, São Paulo, 14784-400, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159659
São José do Rio Preto, São Paulo, 15090-000, Brazil
Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159658
Rio de Janeiro, 20231-050, Brazil
UMHAT Tsaritsa Joanna - ISUL /ID# 159638
Sofia, 1527, Bulgaria
UMHAT Sv. Ivan Rilski /ID# 159639
Sofia, 1612, Bulgaria
British Columbia Cancer Agency /ID# 163721
Surrey, British Columbia, V3V 1Z2, Canada
Brampton Civic Hospital /ID# 204425
Brampton, Ontario, L6R 3J7, Canada
R.S. McLaughlin Durham Regional /ID# 170870
Oshawa, Ontario, L1G 2B9, Canada
Princess Margaret /ID# 170868
Toronto, Ontario, M5G 2M9, Canada
Windsor Regional Cancer Centre /ID# 170869
Windsor, Ontario, N8W 2X3, Canada
Iucpq-Ul /Id# 159530
Québec, Quebec, G1V 4G5, Canada
Fujian Provincial Cancer Hospital /ID# 204864
Fuzhou, Fujian, 350014, China
Harbin Medical University Cancer Hospital /Id# 203638
Harbin, Heilongjiang, 150081, China
Hubei Cancer Hospital /ID# 202886
Wuhan, Hubei, 430079, China
Jilin Cancer Hosptial /ID# 204060
Changchun, Jilin, 130000, China
The Affiliated Cancer Hospital of Xinjiang Medical university /ID# 203641
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital /ID# 204911
Kunming, Yunnan, 650118, China
Zhejiang Cancer hospital /ID# 204640
Hangzhou, Zhejiang, 310022, China
Sir Run Run Shaw Hospital /ID# 206802
Jianggan Hangzhou, Zhejiang, 310018, China
Jiangsu Province Hospital /ID# 205183
Nanjing, 210029, China
4th Military Medical Universit /ID# 203986
Xi'an, 710038, China
First Affiliated Hospital of Xi'an Jiaotong University /ID# 203733
Xi'an, 710061, China
Henan Cancer Hospital /ID# 203983
Zhengzhou Henan, 450008, China
Henan Cancer Hospital /ID# 204636
Zhengzhou Henan, 450008, China
Klinicki bolnicki centar Sestre milosrdnice /ID# 159090
Zagreb, City of Zagreb, 10000, Croatia
Klinika za plucne bolesti Jordanovac /ID# 159505
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Rijeka /ID# 159504
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Thomayerova nemocnice /ID# 159062
Prague, Praha 4, 140 59, Czechia
Nemocnice Rudolfa a Stefanie /ID# 159655
Benešov, 256 01, Czechia
Nemocnice Horovice a.s. /ID# 161186
Hořovice, 268 31, Czechia
Vitkovicka nemocnice a. s. /ID# 161187
Ostrava, 703 84, Czechia
FN Plzen /ID# 204097
Pilsen, 323 00, Czechia
Oblastni Nemocnice Pribram /ID# 159654
Příbram, 262 04, Czechia
Rigshospitalet /ID# 158055
Copenhagen Ø, Capital Region, 2100, Denmark
Herlev Hospital /ID# 158053
Herlev, Capital Region, 2730, Denmark
Aalborg University Hospital /ID# 203737
Aalborg, North Denmark, 9000, Denmark
Odense Universitets Hospital /ID# 158054
Odense C, Region Syddanmark, 5000, Denmark
East Tallinn Central Hospital /ID# 160019
Tallinn, 10138, Estonia
North Estonian Medical Centre /ID# 159779
Tallinn, 13419, Estonia
Docrates Cancer Center /ID# 159591
Helsinki, 00180, Finland
CHU Hopital Nord /ID# 160543
Marseille, Bouches-du-Rhone, 13915, France
Hopital Haut-Lévêque /ID# 160547
Pessac, Gironde, 33604, France
CHU Calmette /ID# 202706
Lille, Hauts-de-France, 59000, France
Centre Leon Berard /ID# 160550
Lyon, Rhone, 69373, France
Centre Hosp Intercommunal de Creteil /ID# 162686
Créteil, Val-de-Marne, 94000, France
Hopital Tenon /ID# 160541
Paris, 75970, France
Hospital Pontchaillou /ID# 160544
Rennes, 35033, France
Nouvel Hopital Civil (NHC) /ID# 204427
Strasbourg, 67091, France
Hopital Larrey /ID# 204290
Toulouse, 31059, France
Institut Curie /ID# 207514
Paris, Île-de-France Region, 75248, France
KH Martha-Maria Halle Dolau /ID# 158794
Halle, Saxony-Anhalt, 06120, Germany
Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 158783
Berlin, 10117, Germany
Evangelische Lungenklinik Berl /ID# 158935
Berlin, 13125, Germany
Asklepios Fachkliniken M. Gaut /ID# 158789
Gauting, 82131, Germany
Thoraxklinik Heidelberg gGmbH /ID# 158871
Heidelberg, 69126, Germany
Lungenklinik Hemer /ID# 158790
Hemer, 58675, Germany
Klinikum Kassel /ID# 158786
Kassel, 34125, Germany
Klinik Loewenstein GmbH /ID# 158870
Löwenstein, 74245, Germany
Fachkliniken Wangen /ID# 160779
Wangen, 88239, Germany
Metropolitan General Hospital /ID# 202422
Cholargós, Attica, 15562, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159160
Athens, 11527, Greece
Metropolitan Hospital /ID# 159157
Athens, 18547, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 202409
Heraklion, 71110, Greece
University Hospital of Ioannin /ID# 159158
Ioannina, 45500, Greece
General Oncological Hospital /ID# 159159
Nea Kifissia, 14564, Greece
Euromedica General Clinic /ID# 159156
Thessaloniki, 54645, Greece
Queen Elizabeth Hospital /ID# 159565
Kowloon, 852, Hong Kong
Princess Margaret Hospital /ID# 162810
Lai Chi Kok, 999077, Hong Kong
Tuen Mun Hospital /ID# 162435
Tuenmen, 999077, Hong Kong
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 158962
Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary
Orszagos Koranyi Pulmonologiai Intezet /ID# 158953
Budapest XII, Budapest, 1122, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz - Pulmonologia /ID# 202466
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
Semmelweis Egyetem /ID# 158955
Budapest, 1085, Hungary
Csongrad Megyei Mellkasi Beteg /ID# 158952
Deszk, 6772, Hungary
St. James's Hospital /ID# 159712
Dublin, Dublin, D08 E9P6, Ireland
Cork University Hospital /ID# 159715
Cork, T12 E8YV, Ireland
St Vincent's University Hosp /ID# 161678
Dublin, D04 T6F4, Ireland
Beaumont Hospital /ID# 159711
Dublin, D09 XR63, Ireland
University Hospital Limerick /ID# 159714
Limerick, V94F858, Ireland
University Hospital Waterford /ID# 159713
Waterford, X91 ER8E, Ireland
Rabin Medical Center /ID# 159764
Petakh Tikva, Tel Aviv, 4941492, Israel
Tel Aviv Sourasky Medical Center /ID# 161467
Tel Aviv, Tel Aviv, 6423906, Israel
Soroka University Medical Center /ID# 159762
Beersheba, 84101, Israel
Assaf Harofeh Medical Center /ID# 201883
Be’er Ya‘aqov, 70300, Israel
Rambam Health Care Campus /ID# 202336
Haifa, 3109601, Israel
Hadassah /ID# 159763
Jerusalem, 91120, Israel
Meir Medical Center /ID# 159761
Kfar Saba, 4428164, Israel
Sheba Medical Center /ID# 159760
Ramat Gan, 5239424, Israel
IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 160898
Meldola, Emilia-Romagna, 47014, Italy
Policlinico Universitario Campus Bio-Medico /ID# 160874
Rome, Lazio, 00128, Italy
AUSL 8 Arezzo Ospedale San Don /ID# 160897
Arezzo, 52100, Italy
A.O.U. San Luigi Gonzaga /ID# 158916
Orbassano, 10043, Italy
Ospedale Santa Maria delle Cro /ID# 158911
Ravenna, 48121, Italy
IFO Istituto Nazionale Tumori /ID# 158912
Rome, 00144, Italy
Aichi Cancer Center Hospital /ID# 164976
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East /ID# 165721
Kashiwa-shi, Chiba, 277-8577, Japan
Kyushu University Hospital /ID# 165722
Fukuoka, Fukuoka, 812-8582, Japan
Kurume University Hospital /ID# 164595
Kurume-shi, Fukuoka, 830-0011, Japan
Kanazawa University Hospital /ID# 165127
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kanagawa Cardiovascular and Respiratory Center /ID# 165015
Yokohama, Kanagawa, 236-0051, Japan
Yokohama City University Hospital /ID# 165746
Yokohama, Kanagawa, 2360004, Japan
Japanese Red Cross Okayama Hospital /ID# 165157
Okayama, Okayama-ken, 7008607, Japan
Kansai Medical University Hospital /ID# 165054
Hirakata-shi, Osaka, 573-1191, Japan
Kindai University Hospital /ID# 166395
Osaka-sayama-shi, Osaka, 589-8511, Japan
Shizuoka Cancer Center /ID# 166272
Sunto-gun, Shizuoka, 411-8777, Japan
Tokushima University Hospital /ID# 166105
Tokushima, Tokushima, 770-8503, Japan
National Cancer Center Hospital /ID# 166547
Chuo-ku, Tokyo, 104-0045, Japan
Showa University Hospital /ID# 165575
Shinagawa-ku, Tokyo, Japan
Wakayama Medical University /ID# 165946
Wakayama, Wakayama, 641-8510, Japan
Hyogo Cancer Center /ID# 165138
Akashi, 673-8558, Japan
National Hospital Organization Himeji Medical Center /ID# 165899
Himeji, 670-8520, Japan
Matsusaka City Hospital /ID# 166156
Matsusaka-shi MIE, 515-8544, Japan
Osaka City General Hospital /ID# 165714
Osaka, 534-0021, Japan
Hokkaido Cancer Center /ID# 165236
Sapporo, 003-0804, Japan
Sendai Kousei Hospital /ID# 166491
Sendai, 980-0873, Japan
Kanagawa Cancer Center /ID# 165814
Yokohama, 241-0815, Japan
Pauls Stradins Clinical /ID# 158715
Riga, LV-1002, Latvia
Riga East Clinical University /ID# 158716
Riga, LV-1079, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 160016
Kaunas, Kaunas County, 50009, Lithuania
Klaipeda University Hospital /ID# 160018
Klaipėda, LT-92288, Lithuania
National Cancer Institute /ID# 160017
Vilnius, 08660, Lithuania
Centro de Investigación Clinica Chapultepec /ID# 160965
Morelia, Michoacán, 58260, Mexico
Health Pharma professional Ser /ID# 160734
Mexico City, 03810, Mexico
Jeroen Bosch Ziekenhuis /ID# 158081
's-Hertogenbosch, 5223 GZ, Netherlands
Meander Medisch Centrum /ID# 159064
Amersfoort, 3813 TZ, Netherlands
Rijnstate /ID# 159063
Arnhem, 6815 AD, Netherlands
Amphia Ziekenhuis /ID# 159065
Breda, 4818 CK, Netherlands
Catharina Ziekenhuis /ID# 158082
Eindhoven, 5623 EJ, Netherlands
Maastricht Universitair Medisch Centrum /ID# 161669
Maastricht, 6229 HX, Netherlands
Universitair Medisch Centrum Utrecht /ID# 158083
Utrecht, 3584 CX, Netherlands
Akershus universitetssykehus /ID# 201682
Nordbyhagen, Akershus, 1474, Norway
Drammen Sykehus /ID# 159572
Drammen, Buskerud, 3004, Norway
Haukeland University Hospital /ID# 159573
Bergen, Hordaland, 5021, Norway
St. Olavs Hospital HF /ID# 163110
Trondheim, Sor-Trondelag, 7006, Norway
Radiumhospitalet, OUS /ID# 159574
Oslo, 0379, Norway
Stavanger Universitetssykehus /ID# 159575
Stavanger, 4011, Norway
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 159604
Rzeszów, Podkarpackie Voivodeship, 35-021, Poland
Wojewodzki Szpital Specjalisty /ID# 159603
Bytom, 41-902, Poland
Szpitale Pomorskie Sp. z o.o /ID# 159605
Gdynia, 81-519, Poland
Centro Hospitalar Lisboa Norte, EPE /ID# 159957
Lisbon, Lisbon District, 1769-001, Portugal
IPO Lisboa FG, EPE /ID# 159949
Lisbon, 1099-023, Portugal
Hospital da Luz, SA /ID# 159954
Lisbon, 1500-650, Portugal
Unidade Local Saude Matosinhos /ID# 159950
Matosinhos Municipality, 4464-513, Portugal
Centro Hospitalar do Porto EPE /ID# 203582
Porto, 4099-001, Portugal
Hospital CUF Porto /ID# 159955
Porto, 4100-180, Portugal
IPO Porto FG, EPE /ID# 159956
Porto, 4200-072, Portugal
National Medical Research Cntr /ID# 169885
Moscow, Moscow Oblast, 115478, Russia
Arkhangelsk clinical oncology /ID# 159367
Arkhangelsk, 163045, Russia
Kaluga Regional Clinical Oncol /ID# 160180
Kaluga, 284007, Russia
Clinical Onco Dispensary /ID# 159365
Omsk, 644013, Russia
PMI Euromedservice /ID# 159369
Pushkin, 196603, Russia
LLC Novaya Clinica /ID# 205523
Pyatigorsk, 357532, Russia
LLC BioEq Ltd. /ID# 159368
Saint Petersburg, 197342, Russia
OOO Centre of Palliative Medicine De Vita /ID# 206855
Saint Petersburg, 197343, Russia
N.N. Petrov Research Inst Onc /ID# 159370
Saint Petersburg, 197758, Russia
Ogarev Mordovia State Univ /ID# 205742
Saransk, 430005, Russia
Smolensk Regional Onc Clin Dis /ID# 159372
Smolensk, 214009, Russia
Clinical Center Serbia /ID# 160902
Belgrade, Beograd, 11000, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 160903
Belgrade, Beograd, 11080, Serbia
Clinical Center of Nis /ID# 160905
Niš, Nisavski Okrug, 18000, Serbia
Institut za onkologiju i radio /ID# 160904
Belgrade, 11000, Serbia
Institute For Pulmonary Diseas /ID# 164250
Kamenitz, 21204, Serbia
Cancercare Langenhoven Drive Oncology Centre /ID# 159126
Port Elizabeth, Eastern Cape, 6045, South Africa
Dr Albert, Bouwer and Jordaan Incorporated /ID# 158873
Pretoria, Gauteng, 0044, South Africa
Mary Potter Oncology Centre /ID# 158877
Pretoria, Gauteng, 0181, South Africa
The Oncology Centre /ID# 158872
Durban, KwaZulu-Natal, 4091, South Africa
Cape Town Oncology Trials /ID# 201311
Cape Town, Western Cape, 7570, South Africa
Cancercare Outeniqua Oncology Unit /ID# 200689
George, Western Cape, 6530, South Africa
Dong-A University Hospital /ID# 159305
Busan, Busan Gwang Yeogsi, 49201, South Korea
CHA Bundang Medical center CHA University /ID# 161281
Seongnam-si, Gyeonggido, 13496, South Korea
Kyungpook National University Chilgok Hospital /ID# 159301
Daegu, Seoul Teugbyeolsi, 41404, South Korea
Samsung Medical Center /ID# 159304
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Korea University Guro Hospital /ID# 159302
Seoul, Seoul Teugbyeolsi, 08308, South Korea
Chungbuk National University /ID# 159300
Cheongju-si, 28644, South Korea
Severance Hospital /ID# 159297
Seoul, 03722, South Korea
Asan Medical Center /ID# 159299
Seoul, 05505, South Korea
Hospital Teresa Herrera - CHUAC /ID# 164368
A Coruña, A Coruna, 15006, Spain
Hospital Regional de Malaga /ID# 164371
Málaga, Malaga, 29010, Spain
Hospital Parc de Salut del Mar /ID# 159690
Barcelona, 08003, Spain
Hospital Universitario Vall d'Hebron /ID# 159708
Barcelona, 08035, Spain
Hospital Clinico Universitario San Carlos /ID# 159706
Madrid, 28040, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 159693
Madrid, 28040, Spain
Hospital Universitario La Paz /ID# 159692
Madrid, 28046, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 159709
Zaragoza, 50009, Spain
Centralsjukhuset, Karlstad /ID# 163451
Karlstad, Värmland County, 651 85, Sweden
Sahlgrenska US Gbg /ID# 159524
Gothenburg, Västra Götaland County, 413 46, Sweden
University Hospital Linkoping /ID# 159046
Linköping, 581 85, Sweden
Karolinska Univ Sjukhuset /ID# 159649
Solna, 17176, Sweden
Uppsala University Hospital /ID# 159052
Uppsala, 75185, Sweden
Hopitaux Universitaires de Geneve /ID# 160603
Geneva, Canton of Geneva, 1205, Switzerland
Kantonsspital St. Gallen /ID# 160604
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Universitaetsspital Basel /ID# 160605
Basel, 4031, Switzerland
Luzerner Kantonsspital /ID# 160607
Lucerne, 6000, Switzerland
Kantonsspital Winterthur /ID# 161379
Winterthur, 8401, Switzerland
China Medical University Hosp /ID# 158981
Taichung, Taichung, 40447, Taiwan
National Cheng Kung University Hospital /ID# 158799
Tainan, Tainan, 70403, Taiwan
National Taiwan Univ Hosp /ID# 159049
Taipei City, Taipei, 10002, Taiwan
Tri-Service General Hospital /ID# 158980
Taipei City, Taipei, 11490, Taiwan
Dalin Tzu Chi General Hospital /ID# 158983
Dalin Township, 622, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 158798
Kaohsiung City, 80708, Taiwan
Taichung Veterans General Hosp /ID# 159047
Taichung, 40705, Taiwan
Taipei Veterans General Hosp /ID# 203699
Taipei, 11217, Taiwan
Hacettepe University Medical Faculty /ID# 159242
Altindağ, Ankara, 06250, Turkey (Türkiye)
Erciyes University Medical Fac /ID# 202269
Melikgazi, Kayseri, 38030, Turkey (Türkiye)
Ataturk Gogus Hastalikl /ID# 159556
Ankara, 06280, Turkey (Türkiye)
Akdeniz Universitesi Tip Fakul /ID# 160791
Antalya, 07059, Turkey (Türkiye)
Bezmi alem Vakif Universitesi /ID# 202267
Istanbul, 34093, Turkey (Türkiye)
Istanbul Medeniyet Universites /ID# 200126
Istanbul, 34722, Turkey (Türkiye)
Ege University Medical Faculty /ID# 159243
Izmir, 35040, Turkey (Türkiye)
Dr. Suat Seren Gogus Has /ID# 159244
Izmir, 35110, Turkey (Türkiye)
Inonu University /ID# 159245
Malatya, 44280, Turkey (Türkiye)
CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159131
Zaporizhzhia, Zaporizhzhia Oblast, 69040, Ukraine
Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 159864
Chernivtsi, 58013, Ukraine
Municipal institution Multifie /ID# 159130
Dnipro, 49102, Ukraine
Regional Center of Oncology /ID# 159132
Kharkiv, 61070, Ukraine
PE PMC Acinus, Medical and Diagnostic Center /ID# 165543
Kropyvnytskyi, 25006, Ukraine
Volyn Regional Medical Oncology Centre /ID# 159133
Lutsk, 43018, Ukraine
Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159865
Uzhhorod, 88000, Ukraine
Cheltenham General Hospital /ID# 169096
Cheltenham, Gloucestershire, GL53 7AN, United Kingdom
Queen Elizabeth Medical Centre /ID# 162899
Birmingham, B15 2TH, United Kingdom
The Royal Bournemouth Hospital /ID# 159039
Bournemouth, BH7 7DW, United Kingdom
Colchester General Hospital /ID# 159042
Colchester, CO4 5JL, United Kingdom
Hereford County Hospital /ID# 159038
Hereford, HR1 2ER, United Kingdom
St. George's Healthcare NHS /ID# 202416
London, SW17 0QT, United Kingdom
Charing Cross Hospital /ID# 161399
London, W6 8RF, United Kingdom
Maidstone Hospital /ID# 159043
Maidstone, ME16 9QQ, United Kingdom
Christie NHS Foundation Trust /ID# 159037
Manchester, M20 4BX, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 159044
Newcastle upon Tyne, NE7 7DN, United Kingdom
Torbay Hospital - So Devon HC /ID# 159041
Torquay, TQ2 7AA, United Kingdom
Related Publications (1)
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.
PMID: 29290251DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 25, 2017
First Posted
January 26, 2017
Study Start
February 7, 2017
Primary Completion
November 20, 2019
Study Completion
November 20, 2019
Last Updated
July 29, 2021
Results First Posted
December 21, 2020
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.