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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03033511
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : May 3, 2019
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Placebo for dexamethasone Drug: Placebo for rovalpituzumab tesirine Drug: Rovalpituzumab tesirine Drug: Dexamethasone Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 740 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : February 7, 2017
Estimated Primary Completion Date : November 14, 2019
Estimated Study Completion Date : September 22, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Rovalpituzumab tesirine/dexamethasone
Rovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle
Drug: Rovalpituzumab tesirine
Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle

Drug: 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.

Experimental: Placebo
Placebo q6 wk; omitting every third cycle
Drug: Placebo for dexamethasone
Placebo for 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.

Drug: Placebo for rovalpituzumab tesirine
Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle

Primary Outcome Measures :
  1. Progression-free survival (PFS) determined by a Central Radiographic Assessment Committee (CRAC) in participants with ED SCLC tumors with a high level of DLL3 expression [ Time Frame: Approximately 24 months since the first subject enrolled ]
    PFS is defined as the number of months from randomization to disease progression, as assessed by the CRAC per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death of any cause, whichever occurs first.

  2. Overall survival (OS) in participants with ED SCLC tumors with a high level of DLL3 expression [ Time Frame: Approximately 31 months since first subject enrolled ]
    OS is defined as the number of months from randomization to death of any cause.

Secondary Outcome Measures :
  1. Change in patient reported outcomes (PROs)--physical functioning domain [ Time Frame: Approximately 31 months since first subject enrolled ]
    EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Lung Cancer Module (QLQ-LC13) is a supplementary lung cancer-specific questionnaire to be used in conjunction with the EORTC QLQ-C30

  2. Progression-free survival (PFS) per RECIST v1.1 in all randomized participants [ Time Frame: Approximately 24 months since the first subject enrolled ]
    PFS is defined as the number of months from randomization to disease progression, determined by CRAC per RECIST version 1.1, or death of any cause, whichever occurs first.

  3. Overall survival (OS) in all randomized participants [ Time Frame: Approximately 31 months since first subject enrolled ]
    OS is defined as the number of months from randomization to death of any cause.

Information from the National Library of Medicine

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

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteria for SCLC.
  • 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.

Information from the National Library of Medicine

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

Please refer to this study by its identifier (NCT number): NCT03033511

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Contact: ABBVIE CALL CENTER 847.283.8955

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United States, Alabama
Clearview Cancer Institute /ID# 156699 Recruiting
Huntsville, Alabama, United States, 35805
University of South Alabama /ID# 160975 Recruiting
Mobile, Alabama, United States, 36604-3302
United States, Arkansas
Highlands Oncology Group /ID# 156722 Recruiting
Fayetteville, Arkansas, United States, 72703-4005
United States, California
Marin Cancer Care /ID# 159207 Completed
Greenbrae, California, United States, 94904
Ucsd /Id# 157764 Recruiting
La Jolla, California, United States, 92093
LA Hem-Oncology Med Group /ID# 156717 Recruiting
Los Angeles, California, United States, 90017
Palo Alto Veterans Institute for Research /ID# 203695 Recruiting
Palo Alto, California, United States, 94304-1207
St Jude Hospital dba St Joseph /ID# 156526 Recruiting
Santa Rosa, California, United States, 95403
Icri /Id# 157765 Recruiting
Whittier, California, United States, 90603
United States, Colorado
Kaiser Permanente Lone Tree /ID# 159331 Recruiting
Lone Tree, Colorado, United States, 80124
United States, Delaware
Christiana Care Health Service /ID# 159212 Recruiting
Newark, Delaware, United States, 19713
United States, Florida
Holy Cross Hospital /ID# 156716 Recruiting
Fort Lauderdale, Florida, United States, 33308
University of Florida /ID# 155799 Recruiting
Gainesville, Florida, United States, 32610
Memorial Cancer Institute /ID# 156673 Completed
Hollywood, Florida, United States, 33021-5421
Memorial Cancer Institute /ID# 164052 Completed
Hollywood, Florida, United States, 33021-5421
Cancer Specialists of North Florida - Southpoint /ID# 156595 Recruiting
Jacksonville, Florida, United States, 32256
United States, Georgia
Georgia Cancer Center /ID# 201894 Completed
Atlanta, Georgia, United States, 30342
Southeastern Regional Medical /ID# 163064 Recruiting
Newnan, Georgia, United States, 30265
United States, Idaho
St. Luke's Mountain States Tumor Institute /ID# 156691 Recruiting
Boise, Idaho, United States, 83712-6267
United States, Illinois
NorthShore University HealthSystem - Evanston /ID# 156664 Recruiting
Evanston, Illinois, United States, 60201
Ingalls Memorial Hosp /ID# 156685 Completed
Harvey, Illinois, United States, 60426
United States, Indiana
Goshen Center for Cancer Care /ID# 156682 Recruiting
Goshen, Indiana, United States, 46526
United States, Kentucky
Ashland-Bellefonte Cancer Ctr /ID# 202901 Recruiting
Ashland, Kentucky, United States, 41101
University of Louisville /ID# 156683 Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Clinic Foundation /ID# 159136 Recruiting
New Orleans, Louisiana, United States, 70121
United States, Michigan
Henry Ford Health System /ID# 156712 Recruiting
Detroit, Michigan, United States, 48202
Edward W. Sparrow Hosp Assn /ID# 156590 Recruiting
Lansing, Michigan, United States, 48912
United States, Minnesota
Mayo Clinic - Rochester /ID# 160181 Recruiting
Rochester, Minnesota, United States, 55905-0001
United States, Missouri
MidAmerica Division, Inc. /ID# 163530 Recruiting
Kansas City, Missouri, United States, 64132
United States, Montana
Billings Clinic /ID# 201788 Recruiting
Billings, Montana, United States, 59101-0733
United States, Nebraska
Nebraska Hematology Oncology /ID# 156534 Recruiting
Lincoln, Nebraska, United States, 68506
United States, New Jersey
MD Anderson Cancer Center at Cooper /ID# 156681 Recruiting
Camden, New Jersey, United States, 08103
United States, New York
Montefiore Medical Center /ID# 201845 Recruiting
Bronx, New York, United States, 10461
Northwell Health, Monter Cance /ID# 159252 Recruiting
Lake Success, New York, United States, 11042
Icahn School of Med Mt. Sinai /ID# 159210 Recruiting
New York, New York, United States, 10029
Stony Brook University Hospital /ID# 159272 Recruiting
Stony Brook, New York, United States, 11794-8183
United States, North Carolina
Duke Univ Med Ctr /ID# 156706 Completed
Durham, North Carolina, United States, 27710
Cone Health /ID# 156689 Recruiting
Greensboro, North Carolina, United States, 27403
Cone Health /ID# 163612 Recruiting
Greensboro, North Carolina, United States, 27403
Eastern Carolina University /ID# 159264 Recruiting
Greenville, North Carolina, United States, 27834
United States, Ohio
Gabrail Cancer Center Research /ID# 156667 Recruiting
Canton, Ohio, United States, 44718
United States, Oregon
Kaiser Permanente, NW /ID# 201793 Recruiting
Portland, Oregon, United States, 97227
United States, Pennsylvania
Thomas Jefferson University /ID# 156719 Recruiting
Philadelphia, Pennsylvania, United States, 19107-4414
VA Pittsburgh HealthcareSystem /ID# 159284 Recruiting
Pittsburgh, Pennsylvania, United States, 15240
United States, Rhode Island
Rhode Island Hospital /ID# 160834 Recruiting
Providence, Rhode Island, United States, 02903
United States, Tennessee
Sarah Cannon Research Institute-Chattanooga /ID# 202933 Recruiting
Chattanooga, Tennessee, United States, 37404-1108
Thompson Cancer Survival Ctr /ID# 202460 Recruiting
Knoxville, Tennessee, United States, 37916
Tennessee Oncology-Nashville Centennial /ID# 161168 Recruiting
Nashville, Tennessee, United States, 37203-1632
United States, Texas
Univ Medical Ctr Brackenridge /ID# 155798 Completed
Austin, Texas, United States, 78701
Parkland Health and Hosp Syste /ID# 170933 Recruiting
Dallas, Texas, United States, 75235
UT Southwestern Medical Center /ID# 157848 Recruiting
Dallas, Texas, United States, 75390-7208
The Methodist Hospital /ID# 202323 Recruiting
Houston, Texas, United States, 77030
United States, Washington
Medical Oncology Associates /ID# 156715 Recruiting
Spokane, Washington, United States, 99208
United States, West Virginia
West Virginia Univ School Med /ID# 156687 Recruiting
Morgantown, West Virginia, United States, 26506
Australia, New South Wales
Coffs Harbour Hospital /ID# 158880 Recruiting
Coffs Harbour, New South Wales, Australia, 2450
Gosford Hospital /ID# 158884 Recruiting
Gosford, New South Wales, Australia, 2250
Newcastle Private Hospital /ID# 203506 Recruiting
Lambton Heights, New South Wales, Australia, 2305
Royal North Shore Hospital /ID# 158881 Recruiting
Saint Leonards, New South Wales, Australia, 2065
Australia, South Australia
Calvary North Adelaide Hospita /ID# 161701 Completed
Adelaide, South Australia, Australia, 5006
Australia, Victoria
Sunshine Hospital /ID# 161700 Recruiting
St Albans, Victoria, Australia, 3021
Affinity Clinical Research Ser /ID# 158887 Completed
Nedlands, Australia, 6009
SMZ Baumgartner Höhe, Otto-Wagner-Spital und Pflegezentrum /ID# 201768 Recruiting
Vienna, Wien, Austria, 1140
SMZ Baumgartner Höhe, Otto-Wagner-Spital und Pflegezentrum /ID# 201776 Recruiting
Vienna, Wien, Austria, 1140
LKH-Univ. Klinikum Graz /ID# 159563 Recruiting
Graz, Austria, 8036
Ordensklinikum Linz GmbH, Elisabethinen /ID# 159564 Recruiting
Linz, Austria, 4020
Salzburger Landeskliniken (SALK) /ID# 201779 Recruiting
Salzburg, Austria, 5020
Bobruysk Interdistrict Onco. /ID# 169393 Recruiting
Bobruisk, Belarus, 213825
Belarus Cancer Center N.N. Alexandrov /ID# 159383 Recruiting
Lesnoy, Belarus, 223040
Mogilev Reg Clin Oncology Dis /ID# 159384 Recruiting
Mogilev, Belarus, 212018
CHU Saint-Pierre /ID# 159009 Recruiting
Bruxelles, Bruxelles-Capitale, Belgium, 1000
Grand Hôpital de Charleroi /ID# 159006 Recruiting
Charleroi, Hainaut, Belgium, 6000
ZNA Middelheim /ID# 159007 Recruiting
Antwerp, Belgium, 2020
Hopital de Jolimont /ID# 159005 Recruiting
Haine Saint Paul, Belgium, 7100
CHU Charleroi (Vesale) /ID# 159008 Recruiting
Montigny-le-tilleul, Belgium, 6110
Hospital Evangelico de Cachoei /ID# 159657 Recruiting
Cachoeiro de Itapemirim, Espirito Santo, Brazil, 29308-020
Liga Norte Rio Grandense Cont. /ID# 159011 Recruiting
Natal, Rio Grande Do Norte, Brazil, 59075-740
Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 159013 Recruiting
Ijuí, Rio Grande Do Sul, Brazil, 98700-000
Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159661 Recruiting
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
Hospital Sao Lucas da PUCRS /ID# 159662 Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159012 Recruiting
Barretos, Sao Paulo, Brazil, 14784-400
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159659 Recruiting
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
Inca /Id# 159658 Recruiting
Rio de Janeiro, Brazil, 20231-050
UMHAT Tsaritsa Joanna - ISUL /ID# 159638 Completed
Sofia, Bulgaria, 1527
UMHAT Sv. Ivan Rilski /ID# 159639 Completed
Sofia, Bulgaria, 1612
Canada, British Columbia
British Columbia Cancer Agency /ID# 163721 Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Canada, Ontario
Brampton Civic Hospital /ID# 204425 Recruiting
Brampton, Ontario, Canada, L6R 3J7
R.S. McLaughlin Durham Regional /ID# 170870 Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Princess Margaret /ID# 170868 Recruiting
Toronto, Ontario, Canada, M5G 2M9
Windsor Regional Cancer Centre /ID# 170869 Recruiting
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Iucpq /Id# 159530 Recruiting
Sainte-foy, Quebec, Canada, G1V 4G5
China, Fujian
Fujian Medical Univ Union Hosp /ID# 204862 Not yet recruiting
Fuzhou, Fujian, China, 350001
Fujian Provincial Cancer Hospital /ID# 204864 Not yet recruiting
Fuzhou, Fujian, China, 350014
China, Heilongjiang
Harbin Medical University Cancer Hospital /Id# 203638 Not yet recruiting
Haerbin, Heilongjiang, China, 150081
China, Hubei
Hubei Cancer Hospital /ID# 202886 Recruiting
Wuhan, Hubei, China, 430079
China, Hunan
Hunan Cancer Hospital /ID# 202797 Not yet recruiting
Changsha, Hunan, China, 410006
China, Jilin
Jilin Cancer Hosptial /ID# 204060 Recruiting
Changchun, Jilin, China, 130012
China, Xinjiang
The Affiliated Cancer Hospital of Xinjiang Medical university /ID# 203641 Not yet recruiting
Urumqi, Xinjiang, China, 830000
China, Yunnan
Yunnan Cancer Hospital /ID# 204911 Recruiting
Kunming, Yunnan, China, 650118
China, Zhejiang
The First Affiliated Hospital,College of Medicine, Zhejiang University /ID# 203085 Not yet recruiting
Hangzhou, Zhejiang, China, 310003
Sir Run Run Shaw Hospital /ID# 206802 Recruiting
Hangzhou, Zhejiang, China, 310016
Zhejiang Cancer hospital /ID# 204640 Recruiting
Hangzhou, Zhejiang, China, 310022
Beijing Cancer Hospital /ID# 202882 Not yet recruiting
Beijing, China, 100142
The Second Affiliated Hospital of Anhui Medical University /ID# 206899 Not yet recruiting
Hefei, China, 230601
Jiangsu Province Hospital /ID# 205183 Recruiting
Nanjing, China, 210029
Zhongshan Hospital Fudan University /ID# 205521 Not yet recruiting
Shanghai, China, 200032
4th Military Medical Universit /ID# 203986 Recruiting
Xi'an, China, 710038
First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 203733 Recruiting
Xi'an, China, 710061
Henan Cancer Hospital /ID# 203983 Recruiting
Zhengzhou, Henan, China, 450008
Henan Cancer Hospital /ID# 204636 Recruiting
Zhengzhou, Henan, China, 450008
1st Affiliated Hosp of Zhengzh /ID# 203029 Not yet recruiting
Zhengzhou, China, 450052
Klinicki bolnicki centar Sestre milosrdnice /ID# 159090 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinika za plucne bolesti Jordanovac /ID# 159505 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Rijeka /ID# 159504 Recruiting
Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
Thomayerova nemocnice /ID# 159062 Recruiting
Prague, Praha 4, Czechia, 140 59
Nemocnice Rudolfa a Stefanie /ID# 159655 Recruiting
Benesov, Czechia, 256 01
Nemocnice Horovice a.s. /ID# 161186 Recruiting
Horovice, Czechia, 268 31
Vitkovicka nemocnice a. s. /ID# 161187 Recruiting
Ostrava, Czechia, 703 84
FN Plzen /ID# 204097 Recruiting
Plzen, Czechia, 323 00
Oblastni Nemocnice Pribram /ID# 159654 Recruiting
Pribram, Czechia, 262 04
Rigshospitalet /ID# 158055 Recruiting
Copenhagen Ø, Hovedstaden, Denmark, 2100
Herlev Hospital /ID# 158053 Recruiting
Herlev, Hovedstaden, Denmark, 2730
Aalborg University Hospital /ID# 203737 Recruiting
Aalborg, Nordjylland, Denmark, 9000
Odense Universitets Hospital /ID# 158054 Recruiting
Odense C, Syddanmark, Denmark, 5000
East Tallinn Central Hospital /ID# 160019 Recruiting
Tallinn, Estonia, 10138
North Estonian Medical Centre /ID# 159779 Recruiting
Tallinn, Estonia, 13419
Docrates Cancer Center /ID# 159591 Completed
Helsinki, Finland, 00180
CHU Hopital Nord /ID# 160543 Recruiting
Marseille, Bouches-du-Rhone, France, 13915
Hopital Haut-Lévêque /ID# 160547 Recruiting
Pessac CEDEX, Gironde, France, 33604
CHU Calmette /ID# 202706 Recruiting
Lille, Hauts-de-France, France, 59000
Institut Curie /ID# 207514 Recruiting
Paris CEDEX 05, Ile-de-France, France, 75248
Centre Leon Berard /ID# 160550 Recruiting
Lyon CEDEX 08, Rhone, France, 69373
Centre Hosp Intercommunal /ID# 162686 Recruiting
Creteil, France, 94010
Hopital Tenon /ID# 160541 Recruiting
Paris, France, 75970
Hospital Pontchaillou /ID# 160544 Recruiting
Rennes, France, 35033
Nouvel Hopital Civil (NHC) /ID# 204427 Recruiting
Strasbourg, France, 67091
Hopital Larrey /ID# 204290 Recruiting
Toulouse, France, 31059
KH Martha-Maria Halle Dolau /ID# 158794 Recruiting
Halle (Saale), Sachsen-Anhalt, Germany, 06120
Charité Universitätsmedizin Campus Mitte /ID# 158783 Recruiting
Berlin, Germany, 10117
Evangelische Lungenklinik Berl /ID# 158935 Recruiting
Berlin, Germany, 13125
Asklepios Fachkliniken M. Gaut /ID# 158789 Recruiting
Gauting, Germany, 82131
Thoraxklinik Heidelberg gGmbH /ID# 158871 Recruiting
Heidelberg, Germany, 69126
Lungenklinik Hemer /ID# 158790 Completed
Hemer, Germany, 58675
Klinikum Kassel /ID# 158786 Recruiting
Kassel, Germany, 34125
Klinik Loewenstein GmbH /ID# 158870 Recruiting
Löwenstein, Germany, 74245
Fachkliniken Wangen /ID# 160779 Completed
Wangen, Germany, 88239
Metropolitan General Hospital /ID# 202422 Recruiting
Cholargos, Attiki, Greece, 15562
General Hospital of Chest Diseases of Athens "SOTIRIA" /ID# 159160 Recruiting
Athens, Greece, 11527
Metropolitan Hospital /ID# 159157 Recruiting
Athens, Greece, 18547
University General Hospital of Heraklion "PA.G.N.I" /ID# 202409 Recruiting
Heraklion, Greece, 71110
University Hospital of Ioannin /ID# 159158 Recruiting
Ioannina, Greece, 45500
General Oncological Hospital /ID# 159159 Recruiting
Nea Kifisia, Greece, 14564
Euromedica General Clinic /ID# 159156 Recruiting
Thessaloniki, Greece, 54645
Hong Kong
Queen Elizabeth Hospital /ID# 159565 Recruiting
Kowloon, Hong Kong, 852
Princess Margaret Hospital /ID# 162810 Recruiting
Lai Chi Kok, Hong Kong, 999077
Tuen Mun Hospital /ID# 162435 Recruiting
Tuen Mun, Hong Kong, 999077
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 158962 Recruiting
Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz - Pulmonologia /ID# 202466 Recruiting
Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
Semmelweis Egyetem /ID# 158955 Recruiting
Budapest, Hungary, 1085
Orszagos Koranyi TBC/Pulmon /ID# 158953 Recruiting
Budapest, Hungary, 1121
Csongrad Megyei Mellkasi Beteg /ID# 158952 Completed
Deszk, Hungary, 6772
St. James's Hospital /ID# 159712 Recruiting
Dublin 8, Dublin, Ireland, D08 E9P6
Cork University Hospital /ID# 159715 Recruiting
Cork, Ireland, T12 E8YV
St Vincent's University Hosp /ID# 161678 Recruiting
Dublin, Ireland, D04 T6F4
Beaumont Hospital /ID# 159711 Recruiting
Dublin, Ireland, D09 XR63
University Hospital Limerick /ID# 159714 Recruiting
Limerick, Ireland, V94F858
University Hospital Waterford /ID# 159713 Recruiting
Waterford, Ireland, X91 ER8E
Rabin Medical Center /ID# 159764 Recruiting
Petakh Tikva, Tel-Aviv, Israel, 4941492
Tel Aviv Sourasky Medical Ctr /ID# 161467 Completed
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Soroka Medical Ctr /ID# 159762 Recruiting
Be'er Sheva, Israel, 84101
Assaf Harofeh Medical Center /ID# 201883 Recruiting
Be'er Ya'akov, Israel, 70300
Rambam Health Care Campus /ID# 202336 Recruiting
Haifa, Israel, 3109601
Hadassah /ID# 159763 Recruiting
Jerusalem, Israel, 91120
Meir Medical Center /ID# 159761 Recruiting
Kfar Saba, Israel, 44281
Sheba Medical Center /ID# 159760 Recruiting
Ramat Gan, Israel, 5262100
IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 160898 Recruiting
Meldola, Emilia-Romagna, Italy, 47014
Policlinico Universitario Campus Bio-Medico /ID# 160874 Recruiting
Rome, Lazio, Italy, 00128
AUSL 8 Arezzo Ospedale San Don /ID# 160897 Completed
Arezzo, Italy, 52100
A.O.U. San Luigi Gonzaga /ID# 158916 Recruiting
Orbassano, Italy, 10043
Ospedale Santa Maria delle Cro /ID# 158911 Recruiting
Ravenna, Italy, 48121
IFO Istituto Nazionale Tumori /ID# 158912 Recruiting
Rome, Italy, 00144
Aichi Cancer Center Hospital /ID# 164976 Recruiting
Nagoya-shi, Aichi, Japan, 464-8681
National Cancer Ctr Hosp East /ID# 165721 Recruiting
Kashiwa-shi, Chiba, Japan, 277-8577
Kyushu University Hospital /ID# 165722 Recruiting
Fukuoka-shi, Fukuoka, Japan, 812-8582
Kurume University Hospital /ID# 164595 Recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
Kanazawa University Hospital /ID# 165127 Recruiting
Kanazawa, Ishikawa, Japan, 920-8641
Yokohama City University Hospital /ID# 165746 Recruiting
Yokohama-shi, Kanagawa, Japan, 2360004
Japanese Red Cross Okayama Hospital /ID# 165157 Recruiting
Okayama-shi, Okayama, Japan, 7008607
Kansai Medical University Hospital /ID# 165054 Recruiting
Hirakata-shi, Osaka, Japan, 573-1191
Kinki University -Osakasayama Campus /ID# 166395 Recruiting
Osakasayama-shi, Osaka, Japan, 589-8511
Shizuoka Cancer Center /ID# 166272 Recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
Tokushima University Hospital /ID# 166105 Recruiting
Tokushima-shi, Tokushima, Japan, 770-8503
National Cancer Center Hospital /ID# 166547 Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Showa University Hospital /ID# 165575 Recruiting
Shinagawa-ku, Tokyo, Japan
Hyogo Cancer Center /ID# 165138 Recruiting
Akashi, Japan, 673-8558
National Hospital Organization Himeji Medical Center /ID# 165899 Recruiting
Himeji, Japan, 670-8520
Matsusaka City Hospital /ID# 166156 Recruiting
Matsusaka-shi, MIE, Japan, 515-8544
Osaka City General Hospital /ID# 165714 Recruiting
Osaka, Japan, 534-0021
Hokkaido Cancer Center /ID# 165236 Recruiting
Sapporo, Japan, 003-0804
Sendai Kousei Hospital /ID# 166491 Recruiting
Sendai, Japan, 980-0873
Wakayama Medical University /ID# 165946 Recruiting
Wakayama, Japan, 641-8510
Kanagawa Cardio Resp Center /ID# 165015 Recruiting
Yokohama, Japan, 236-0051
Kanagawa Cancer Center /ID# 165814 Recruiting
Yokohama, Japan, 241-0815
Korea, Republic of
Dong-A University Hospital /ID# 159305 Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
CHA Bundang Medical center, CHA University /ID# 161281 Recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
Kyungpook National University Chilgok Hospital /ID# 159301 Recruiting
Daegu, Seoul Teugbyeolsi, Korea, Republic of, 41404
Samsung Medical Center /ID# 159304 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Korea University Guro Hospital /ID# 159302 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
Chungbuk National University /ID# 159300 Recruiting
Cheongju-si, Korea, Republic of, 28644
Severance Hospital /ID# 159297 Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center /ID# 159299 Recruiting
Seoul, Korea, Republic of, 05505
Pauls Stradins Clinical /ID# 158715 Recruiting
Riga, Latvia, LV-1002
Riga East Clinical University /ID# 158716 Recruiting
Riga, Latvia, LV-1079
Hosp Lithuanian Univ Health Sc /ID# 160016 Recruiting
Kovno, Kaunas, Lithuania, 50009
Klaipeda University Hospital /ID# 160018 Recruiting
Klaipeda, Lithuania, LT-92288
National Cancer Institute /ID# 160017 Recruiting
Vilnius, Lithuania, 08660
Instituto Nacional de Cancerol /ID# 160735 Not yet recruiting
Ciudad de México, Ciudad De Mexico, Mexico, 14080
Centro de Invest Clin Chapulte /ID# 160965 Recruiting
Morelia, Michoacan, Mexico, 58260
Health Pharma professional Ser /ID# 160734 Recruiting
Ciudad de México, Mexico, 03810
Meander Medisch Centrum /ID# 159064 Recruiting
Amersfoort, Netherlands, 3813 TZ
Rijnstate /ID# 159063 Recruiting
Arnhem, Netherlands, 6815 AD
Amphia Ziekenhuis /ID# 159065 Recruiting
Breda, Netherlands, 4818 CK
Catharina Ziekenhuis /ID# 158082 Recruiting
Eindhoven, Netherlands, 5623 EJ
Maastricht Universitair Medisch Centrum /ID# 161669 Recruiting
Maastricht, Netherlands, 6229 HX
Jeroen Bosch Ziekenhuis /ID# 158081 Recruiting
S Hertogenbosch, Netherlands, 5223 GZ
Universitair Medisch Centrum Utrecht /ID# 158083 Recruiting
Utrecht, Netherlands, 3584 CX
Akershus universitetssykehus /ID# 201682 Recruiting
Nordbyhagen, Akershus, Norway, 1474
Drammen Sykehus /ID# 159572 Recruiting
Drammen, Buskerud, Norway, 3004
Haukeland University Hospital /ID# 159573 Recruiting
Bergen, Hordaland, Norway, 5021
St. Olavs Hospital HF /ID# 163110 Recruiting
Trondheim, Sor-Trondelag, Norway, 7006
Radiumhospitalet, OUS /ID# 159574 Recruiting
Oslo, Norway, 0379
Stavanger Universitetssykehus /ID# 159575 Recruiting
Stavanger, Norway, 4011
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 159604 Recruiting
Rzeszów, Podkarpackie, Poland, 35-021
Wojewodzki Szpital Specjalisty /ID# 159603 Recruiting
Bytom, Poland, 41- 902
Szpitale Pomorskie Sp. z o.o /ID# 159605 Recruiting
Gdynia, Poland, 81-519
Centro Hospitalar Lisboa Norte, EPE /ID# 159957 Recruiting
Lisbon, Lisboa, Portugal, 1769-001
IPO Lisboa FG, EPE /ID# 159949 Recruiting
Lisboa, Portugal, 1099-023
Hospital da Luz, SA /ID# 159954 Recruiting
Lisbon, Portugal, 1500-650
Unidade Local Saude Matosinhos /ID# 159950 Recruiting
Matosinhos, Portugal, 4464-513
Centro Hospitalar do Porto EPE /ID# 203582 Recruiting
Porto, Portugal, 4099-001
Hospital CUF Porto /ID# 159955 Recruiting
Porto, Portugal, 4100-180
IPO Porto FG, EPE /ID# 159956 Recruiting
Porto, Portugal, 4200-072
Russian Federation
National Medical Research Cntr /ID# 169885 Recruiting
Moscow, Moskovskaya Oblast, Russian Federation, 115478
Arkhangelsk clinical oncology /ID# 159367 Recruiting
Arkhangelsk, Russian Federation, 163045
Kaluga Regional Clinical Oncol /ID# 160180 Completed
Kaluga, Russian Federation, 284007
Clinical Onco Dispensary /ID# 159365 Recruiting
Omsk, Russian Federation, 644013
PMI Euromedservice /ID# 159369 Recruiting
Pushkin, Russian Federation, 196603
LLC Novaya Clinica /ID# 205523 Recruiting
Pyatigorsk, Russian Federation, 357532
OOO Centre of Palliative Medicine De Vita /ID# 206855 Recruiting
Saint Petersburg, Russian Federation, 197343
Ogarev Mordovia State Univ /ID# 205742 Recruiting
Saransk, Russian Federation, 430005
Smolensk Regional Onc Clin Dis /ID# 159372 Recruiting
Smolensk, Russian Federation, 214009
LLC BioEq Ltd. /ID# 159368 Recruiting
St. Petersburg, Russian Federation, 197342
N.N. Petrov Research Inst Onc /ID# 159370 Recruiting
St. Petersburg, Russian Federation, 197758
Clinical Center Serbia /ID# 160902 Recruiting
Belgrade, Beograd, Serbia, 11000
Clin Hosp Ctr Bezanijska Kosa /ID# 160903 Recruiting
Belgrade, Beograd, Serbia, 11080
Clinical Center of Nis /ID# 160905 Recruiting
NIS, Nisavski Okrug, Serbia, 18000
Institut za onkologiju i radio /ID# 160904 Recruiting
Belgrade, Serbia, 11000
Institute For Pulmonary Diseas /ID# 164250 Recruiting
Sremska Kamenica, Serbia, 21204
South Africa
Langenhoven Drive Onco Cent /ID# 159126 Recruiting
Port Elizabeth, Eastern Cape, South Africa, 6045
Life Wilgers Hospital /ID# 158873 Recruiting
Pretoria, Gauteng, South Africa, 0040
Mary Potter Oncology Centre /ID# 158877 Completed
Pretoria, Gauteng, South Africa, 0181
The Oncology Centre /ID# 158872 Recruiting
Durban, Kwazulu-Natal, South Africa, 4091
Cape Town Oncology Trials /ID# 201311 Recruiting
Cape Town, Western Cape, South Africa, 7570
Cancercare Outeniqua Oncology Unit /ID# 200689 Recruiting
George, Western Cape, South Africa, 6530
Hospital Regional de Malaga /ID# 164371 Recruiting
Málaga, Malaga, Spain, 29009
Hospital Teresa Herrera /ID# 164368 Recruiting
A Coruna, Spain, 15006
H. Del Mar, Barcelona /ID# 159690 Recruiting
Barcelona, Spain, 08003
Hospital Univ Vall d'Hebron /ID# 159708 Recruiting
Barcelona, Spain, 08035
Fundacion Jimenez Diaz /ID# 159693 Recruiting
Madrid, Spain, 28040
Hospital Clin Univ San Carlos /ID# 159706 Recruiting
Madrid, Spain, 28040
Hospital Universitario La Paz /ID# 159692 Recruiting
Madrid, Spain, 28046
Hosp Clin Univ Lozano Blesa /ID# 159709 Recruiting
Zaragoza, Spain, 50009
Centralsjukhuset, Karlstad /ID# 163451 Recruiting
Karlstad, Varmlands Lan, Sweden, 651 85
Sahlgrenska US Gbg /ID# 159524 Recruiting
Göteborg, Vastra Gotalands Lan, Sweden, 413 46
University Hospital Linkoping /ID# 159046 Recruiting
Linkoping, Sweden, 58185
Karolinska Univ Sjukhuset /ID# 159649 Recruiting
Solna, Sweden, 17176
Uppsala University Hospital /ID# 159052 Recruiting
Uppsala, Sweden, 75185
Hopitaux Universitaires de Geneve /ID# 160603 Recruiting
Genève, Geneve, Switzerland, 1205
Kantonsspital St. Gallen /ID# 160604 Recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Universitaetsspital Basel /ID# 160605 Recruiting
Basel, Switzerland, 4031
Luzerner Kantonsspital /ID# 160607 Recruiting
Luzern, Switzerland, 6000
Kantonsspital Winterthur /ID# 161379 Recruiting
Winterthur, Switzerland, 8401
China Medical University Hosp /ID# 158981 Completed
Taichung City, Taichung, Taiwan, 40447
National Cheng Kung University Hospital /ID# 158799 Recruiting
Tainan City, Tainan, Taiwan, 70403
National Taiwan Univ Hosp /ID# 159049 Recruiting
Taipei City, Taipei, Taiwan, 10002
Tri-Service General Hospital /ID# 158980 Recruiting
Taipei City, Taipei, Taiwan, 11490
Dalin Tzu Chi General Hospital /ID# 158983 Recruiting
Dalin Township, Taiwan, 622
Kaohsiung Medical University /ID# 158798 Recruiting
Kaohsiung, Taiwan, 80708
Taichung Veterans General Hosp /ID# 159047 Recruiting
Taichung City, Taiwan, 40705
Taipei Veterans General Hosp /ID# 203699 Recruiting
Taipei City, Taiwan, 11217
Hacettepe University Medical Faculty /ID# 159242 Recruiting
Altindağ, Ankara, Turkey, 06250
Erciyes University Medical Fac /ID# 202269 Recruiting
Melikgazi, Kayseri, Turkey, 38030
Ataturk Gogus Hastalikl /ID# 159556 Recruiting
Ankara, Turkey, 06280
Akdeniz Universitesi Tip Fakul /ID# 160791 Recruiting
Antalya, Turkey, 07059
Bezmi alem Vakif Universitesi /ID# 202267 Recruiting
Istanbul, Turkey, 34093
Istanbul Medeniyet Universites /ID# 200126 Recruiting
Istanbul, Turkey, 34722
Ege University Medical Faculty /ID# 159243 Recruiting
Izmir, Turkey, 35040
Dr. Suat Seren Gogus Has /ID# 159244 Recruiting
Izmir, Turkey, 35110
Inonu University /ID# 159245 Recruiting
Malatya, Turkey, 44280
Chernivetskyi Reg Clin Onc Hos /ID# 159864 Recruiting
Chernivtsi, Ukraine, 58013
Municipal institution Multifie /ID# 159130 Recruiting
Dnipro, Ukraine, 49102
Regional Center of Oncology /ID# 159132 Recruiting
Kharkiv, Ukraine, 61070
Medical and Diagnostic Center /ID# 165543 Recruiting
Kropyvnytskyi, Ukraine, 25006
Treatment and prevention /ID# 159133 Recruiting
Lutsk, Ukraine, 43018
Central Regional Clinical Hos. /ID# 159865 Recruiting
Uzhgorod, Ukraine
Zaporozhye regional clinical /ID# 159131 Recruiting
Zaporozhye, Ukraine, 69040
United Kingdom
Cheltenham General Hospital /ID# 169096 Recruiting
Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
Queen Elizabeth Medical Centre /ID# 162899 Recruiting
Birmingham, United Kingdom, B15 2TH
The Royal Bournemouth Hospital /ID# 159039 Recruiting
Bournemouth, United Kingdom, BH7 7DW
Colchester General Hospital /ID# 159042 Recruiting
Colchester, United Kingdom, CO4 5JL
Hereford County Hospital /ID# 159038 Recruiting
Hereford, United Kingdom, HR1 2ER
St. George's Healthcare NHS /ID# 202416 Recruiting
London, United Kingdom, SW17 0QT
Charing Cross Hospital /ID# 161399 Recruiting
London, United Kingdom, W6 8RF
Maidstone Hospital /ID# 159043 Recruiting
Maidstone, United Kingdom, ME16 9QQ
Christie NHS Foundation Trust /ID# 159037 Recruiting
Manchester, United Kingdom, M20 4BX
Freeman Hospital /ID# 159044 Recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Torbay Hospital - So Devon HC /ID# 159041 Recruiting
Torquay, United Kingdom, TQ2 7AA
Sponsors and Collaborators
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Study Director: AbbVie Inc. AbbVie

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AbbVie Identifier: NCT03033511     History of Changes
Other Study ID Numbers: M16-298
2016-003503-64 ( EudraCT Number )
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Extensive-Stage Small Cell Lung Cancer (ED SCLC)
Platinum-Based Chemotherapy
Rovalpituzumab tesirine
first-line chemotherapy
Small Cell Lung Cancer (SCLC)
Delta-like protein 3 (DLL3)

Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors