Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)

PHASE3CompletedINTERVENTIONAL
Enrollment

444

Participants

Timeline

Start Date

April 11, 2017

Primary Completion Date

February 12, 2020

Study Completion Date

February 12, 2020

Conditions
Small Cell Lung Cancer
Interventions
DRUG

Rovalpituzumab tesirine

Powder for solution for infusion in vials.

DRUG

Topotecan

Powder or solution for infusion in vials. Topotecan is commercially available as both a powder and solution for infusion. Availability will vary by region.

DRUG

Dexamethasone

Oral tablet.

Trial Locations (195)

100

National Taiwan University Hospital /ID# 158865, Taipei City

1000

CHU Saint-Pierre /ID# 159521, Brussels

1085

Semmelweis Egyetem /ID# 161197, Budapest

1122

Orszagos Koranyi Pulmonologiai Intezet /ID# 158967, Budapest

1200

Cliniques universitaires Saint /ID# 158751, Brussels

1527

UMHAT Tsaritsa Joanna - ISUL /ID# 159641, Sofia

1612

UMHAT Sv. Ivan Rilski /ID# 159642, Sofia

2045

Torokbalinti Tudogyogyintezet /ID# 207053, Budapest

2100

Rigshospitalet, Finsen Centre /ID# 158051, Copenhagen

2148

Blacktown Hospital /ID# 158907, Blacktown

2217

St George Hospital /ID# 158855, Kogarah

2500

Southern Medical Day Care Ctr /ID# 158853, Wollongong

2730

Herlev Hospital /ID# 158049, Herlev

3000

UZ Leuven /ID# 158752, Leuven

3084

Austin Hospital /ID# 158898, Heidelberg

3233

Matrai Gyogyintezet /ID# 158979, Mátraháza

3350

Ballarat Health Service /ID# 158904, Ballarat

4000

CHU de Liege Sart Tilman /ID# 158753, Liège

4032

The Prince Charles Hospital /ID# 158897, Chermside

Dup_Debreceni Egyetem Klinikai Központ /ID# 161209, Debrecen

5000

Odense Universitets Hospital /ID# 158050, Odense C

6000

Grand Hôpital de Charleroi /ID# 158748, Charleroi

6110

CHU Charleroi (Vesale) /ID# 159756, Montigny-le-Tilleul

7100

Hopital de Jolimont /ID# 159755, Haine-Saint-Paul

8582

Veszprem Megyei Tuedoegyogyint /ID# 162607, Farkasgyepű

9023

Petz Aladar Megyei Oktato Korh /ID# 158978, Győr

10000

Klinicki bolnicki centar Sestre milosrdnice /ID# 158811, Zagreb

Klinika za plucne bolesti Jordanovac /ID# 159502, Zagreb

10043

A.O.U. San Luigi Gonzaga /ID# 158945, Orbassano

11000

Institut za onkologiju i radio /ID# 160058, Belgrade

Klinicki centar Srbije /ID# 160024, Belgrade

11490

Tri-Service General Hospital /ID# 158985, Taipei City

11527

General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159165, Athens

13105

Assis.Publique-Hopital Nord /ID# 160554, Marseille

13125

Evangelische Lungenklinik Berl /ID# 159168, Berlin

13496

CHA Bundang Medical center CHA University /ID# 204416, Seongnam-si

15232

UPMC Hillman Cancer Ctr /ID# 164403, Pittsburgh

18000

Clinical Center of Nis /ID# 160059, Niš

18547

Metropolitan Hospital /ID# 159162, Athens

19713

Christiana Care Health Service /ID# 158171, Newark

20141

Istituto Europeo di Oncologia /ID# 158942, Milan

21204

Institute For Pulmonary Diseas /ID# 158813, Kamenitz

22927

Lungen Clinic Grosshansdorf /ID# 158770, Großhansdorf

25006

PE PMC Acinus, Medical and Diagnostic Center /ID# 159125, Kropyvnytskyi

26506

West Virginia Univ School Med /ID# 155872, Morgantown

28007

Hospital General Universitario Gregorio Maranon /ID# 159025, Madrid

28050

Hospital Universitario HM Sanchinarro /ID# 159024, Madrid

28644

Chungbuk National University /ID# 159291, Cheongju-si

30342

Georgia Cancer Center /ID# 160206, Atlanta

32256

Cancer Specialists of North Florida - Southpoint /ID# 155828, Jacksonville

33604

Hopital Haut-Lévêque /ID# 160558, Pessac

34125

Klinikum Kassel /ID# 158788, Kassel

35033

Hospital Pontchaillou /ID# 160555, Rennes

35040

Ege University Medical Faculty /ID# 159239, Izmir

35110

Dr. Suat Seren Gogus Has /ID# 159240, Izmir

35805

Clearview Cancer Institute /ID# 155873, Huntsville

36604

Mitchell Cancer Institute /ID# 158151, Mobile

40202

University of Louisville /ID# 155947, Louisville

40705

Taichung Veterans General Hosp /ID# 158866, Taichung

41404

Kyungpook National University Chilgok Hospital /ID# 159292, Daegu

43018

Volyn Regional Medical Oncology Centre /ID# 159124, Lutsk

44280

Inonu Universitesi Turgut Ozal /ID# 159241, Battalgazi/malatya

44718

Gabrail Cancer Center Research /ID# 155920, Canton

45500

University Hospital of Ioannin /ID# 159163, Ioannina

46010

Hospital Clinico Universitario de Valencia /ID# 159027, Valencia

46526

Goshen Center for Cancer Care /ID# 155946, Goshen

48121

Ospedale Santa Maria delle Cro /ID# 158940, Ravenna

48912

Sparrow Regional Cancer Center, Sparrow Health System /ID# 157021, Lansing

49102

Municipal institution Multifie /ID# 159121, Dnipro

49201

Dong-A University Hospital /ID# 159296, Busan

50048

ME Kryviy Rih Oncology Dispensary /ID# 159119, Kryviy RIH

51000

Klinicki bolnicki centar Rijeka /ID# 159501, Rijeka

52100

AUSL 8 Arezzo Ospedale San Don /ID# 160967, Arezzo

54645

Euromedica General Clinic /ID# 159161, Thessaloniki

58013

Municipal institution /ID# 159867, Chernivtsi

58260

Centro de Investigación Clinica Chapultepec /ID# 161000, Morelia

60201

NorthShore University HealthSystem - Evanston Hospital /ID# 157054, Evanston

60426

Ingalls Memorial Hosp /ID# 155871, Harvey

61070

Regional Center of Oncology /ID# 159123, Kharkiv

61469

Chonnam National University Hospital /ID# 159294, Gwangju

68506

Nebraska Hematology Oncology /ID# 155900, Lincoln

69040

CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159122, Zaporizhzhia

69126

Thoraxklinik Heidelberg gGmbH /ID# 159169, Heidelberg

69373

Centre Leon Berard /ID# 160561, Lyon

70403

National Cheng Kung University Hospital /ID# 158844, Tainan City

72205

Carti /Id# 156982, Little Rock

72762

Highlands Oncology Group /ID# 155902, Springdale

74245

Klinik Loewenstein GmbH /ID# 159167, Löwenstein

75020

Assistance Publique- Hopitaux /ID# 160552, Paris

75185

Uppsala University Hospital /ID# 159050, Uppsala

78701

Univ Medical Ctr Brackenridge /ID# 156967, Austin

82131

Asklepios Fachkliniken M. Gaut /ID# 158791, Gauting

83712

St. Luke's Mountain States Tumor Institute - Meridian /ID# 164550, Meridian

88000

"Communal Nonprofit Enterprise Central City Clinical Hospital of Uzhhorod City /ID# 159868", Uzhhorod

90017

Los Angeles Hematology Oncolog /ID# 155879, Los Angeles

90211

Cedars-Sinai Medical Center /ID# 157102, Beverly Hills

90603

Icri /Id# 157090, Whittier

92093

Moore UC San Diego Cancer Center /ID# 156965, La Jolla

94000

Centre Hosp Intercommunal de Creteil /ID# 162684, Créteil

95403

St Jude Hospital dba St Joseph /ID# 155899, Santa Rosa

95817

University of California, Davis Comprehensive Cancer Center /ID# 157001, Sacramento

97239

Oregon Health and Science University /ID# 157055, Portland

98109

University of Washington /ID# 162626, Seattle

99208

Medical Oncology Associates /ID# 156856, Spokane

115478

National Medical Research Cntr /ID# 207436, Moscow

119074

National University Hospital /ID# 158802, Singapore

130000

Jilin Cancer Hosptial /ID# 204059, Changchun

163045

Arkhangelsk clinical oncology /ID# 159309, Arkhangelsk

169610

National Cancer Ctr Singapore /ID# 158803, Singapore

196603

PMI Euromedservice /ID# 159311, Pushkin

197342

LLC BioEq Ltd. /ID# 159310, Saint Petersburg

197758

N.N. Petrov Research Inst Onc /ID# 159312, Saint Petersburg

200347

S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 160847, Craiova

212018

Mogilev Reg. Oncologic dispe /ID# 159326, Mogilev

213825

Bobruysk Interdistrict Onco. /ID# 169394, Babruysk

214009

Smolensk Regional Onc Clin Dis /ID# 159314, Smolensk

223040

State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159325, Lesnoy

284007

Kaluga Regional Clinical Oncol /ID# 160179, Kaluga

300166

Oncocenter Oncologie Clinica S /ID# 160848, Timișoara

357500

LLC Novaya Klinika /ID# 205539, Pyatigorsk

510077

Spitalul Judetean de Urgenta A /ID# 160846, Alba

644013

Clinical Onco Dispensary /ID# 159307, Omsk

70836-6455

Ochsner Clinic Foundation /ID# 160807, Baton Rouge

02215

Dana-Farber Cancer Institute /ID# 160210, Boston

75390-7208

UT Southwestern Medical Center /ID# 158150, Dallas

05401-1473

University of Vermont Medical Center /ID# 162317, Burlington

59075-740

Liga Norte Rio Grandense Cont. /ID# 159015, Natal

99010-080

Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159668, Passo Fundo

14784-400

Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159017, Barretos

15090-000

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159666, São José do Rio Preto

20231-050

Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159665, Rio de Janeiro

T6G 1Z2

Cross Cancer Institute /ID# 159519, Edmonton

L8V 1C3

Juravinski Cancer Clinic /ID# 159514, Hamilton

H4J 1C5

Hopital du Sacre Coeur Montreal /ID# 159515, Montreal

G1R 2J6

CHU de Quebec-Universite Laval /ID# 159093, Québec

G5L 5T1

Cisss Du Bas-Saint-Laurent Hopital Regional de Rimouski /Id# 208931, Rimouski

140 59

Thomayerova nemocnice /ID# 159061, Prague

262 04

Nemocnice Na Plesi s.r.o. /ID# 161190, Nová Ves pod Pleší

256 01

Nemocnice Rudolfa a Stefanie /ID# 159652, Benešov

268 31

Nemocnice Horovice a.s. /ID# 161191, Hořovice

602 00

Krajska nemocnice Liberec a.s. /ID# 159653, Liberec

06120

KH Martha-Maria Halle Dolau /ID# 158796, Halle

00144

IFO Istituto Nazionale Tumori /ID# 158941, Rome

464-8681

Aichi Cancer Center Hospital /ID# 164975, Nagoya

277-8577

National Cancer Center Hospital East /ID# 165726, Kashiwa-shi

812-8582

Kyushu University Hospital /ID# 165723, Fukuoka

830-0011

Kurume University Hospital /ID# 164586, Kurume-shi

003-0804

Hokkaido Cancer Center /ID# 165237, Sapporo

673-8558

Hyogo Cancer Center /ID# 165125, Akashi-shi

670-0012

Himeji Medical Center /ID# 165893, Himeji-shi

920-8641

Duplicate_Kanazawa University Hospital /ID# 165129, Kanazawa

236-0004

Yokohama City University Hospital /ID# 165748, Yokohama

236-0051

Kanagawa Cardiovascular and Respiratory Center /ID# 164374, Yokohama

980-0873

Sendai Kousei Hospital /ID# 166061, Sendai

700-8607

Japanese Red Cross Okayama Hospital /ID# 165156, Okayama

573-1191

Kansai Medical University Hospital /ID# 165055, Hirakata-shi

534-0021

Osaka City General Hospital /ID# 165717, Osaka

589-8511

Kindai University Hospital /ID# 166394, Osaka-sayama-shi

411-8777

Shizuoka Cancer Center /ID# 166466, Sunto-gun

770-8503

Tokushima University Hospital /ID# 165812, Tokushima

104-0045

National Cancer Center Hospital /ID# 166768, Chuo-ku

135-8550

The Cancer Institute Hospital Of JFCR /ID# 166249, Koto-ku

142-0054

Duplicate_Showa University Hospital /ID# 165574, Shinagawa-ku

641-8510

Wakayama Medical University /ID# 166032, Wakayama

515-8544

Matsusaka City Hospital /ID# 166126, Matsusaka-shi MIE

241-0815

Kanagawa Cancer Center /ID# 165816, Yokohama

LV-1002

Pauls Stradins Clinical /ID# 158713, Riga

LV-1079

Riga East Clinical University /ID# 158714, Riga

03810

Health Pharma Professional Research S.A de C.V /ID# 160020, Del. Benito Juárez

9713 GZ

Universitair Medisch Centrum Groningen /ID# 158088, Groningen

3844 DG

Ziekenhuis St. Jansdal /ID# 158652, Harderwijk

8025 AB

Isala /ID# 158653, Zwolle

35-021

Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 160537, Rzeszów

80-219

Copernicus PL Sp. z o. o., WCO /ID# 160538, Gdansk

81-519

Szpitale Pomorskie Sp. z o.o /ID# 160536, Gdynia

1769-001

Centro Hospitalar Lisboa Norte, EPE /ID# 158687, Lisbon

1099-023

IPO Lisboa FG, EPE /ID# 158995, Lisbon

1500-650

Hospital da Luz, SA /ID# 158996, Lisbon

4464-513

Unidade Local Saude Matosinhos /ID# 158682, Matosinhos Municipality

4100-180

Hospital CUF Porto /ID# 158685, Porto

4200-072

IPO Porto FG, EPE /ID# 158686, Porto

03722

Yonsei University Health System, Severance Hospital /ID# 159288, Seodaemun-gu

08308

Korea University Guro Hospital /ID# 159293, Seoul

05505

Asan Medical Center /ID# 159290, Seoul

08036

Hospital Clinic /ID# 159031, Barcelona

08041

Hospital Santa Creu i Sant Pau /ID# 159028, Barcelona

413 46

Sahlgrenska US Gbg /ID# 159534, Gothenburg

06250

Hacettepe University Medical Faculty /ID# 159238, Altindağ

06280

Ataturk Gogus Hastaliklari ve /ID# 160056, Kecioren/ankara

SE1 9RT

Guy's and St Thomas' NHS Found /ID# 159581, London

PE21 9QS

United Lincolnshire Hospitals /ID# 159579, Boston

W6 8RF

Charing Cross Hospital /ID# 159582, London

M20 4BX

Christie NHS Foundation Trust /ID# 159099, Manchester

TS4 3BW

James Cook University Hospital /ID# 159583, Middlesbrough

PR2 9HT

Royal Preston Hospital /ID# 159578, Preston

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