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)

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.

Study Overview

• Status: Terminated
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: Rovalpituzumab tesirine; Drug: Dexamethasone; Drug: Placebo for dexamethasone; Drug: Placebo for rovalpituzumab tesirine

• Study Type: Interventional
• Enrollment (Actual): 748
• Phase: Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • Nedlands, Australia, 6009
    • Affinity Clinical Research Ser /ID# 158887
  • New South Wales
    • Coffs Harbour, New South Wales, Australia, 2450
      • Coffs Harbour Hospital /ID# 158880
    • Gosford, New South Wales, Australia, 2250
      • Gosford Hospital /ID# 158884
    • Lambton Heights, New South Wales, Australia, 2305
      • Newcastle Private Hospital /ID# 203506
    • Saint Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital /ID# 158881
  • South Australia
    • Adelaide, South Australia, Australia, 5006
      • Calvary North Adelaide Hospita /ID# 161701
  • Victoria
    • St Albans, Victoria, Australia, 3021
      • Sunshine Hospital /ID# 161700
• Austria
  • Graz, Austria, 8036
    • LKH-Univ. Klinikum Graz /ID# 159563
  • Linz, Austria, 4020
    • Ordensklinikum Linz GmbH, Elisabethinen /ID# 159564
  • Salzburg, Austria, 5020
    • Salzburger Landeskliniken (SALK) /ID# 201779
  • Wien
    • Vienna, Wien, Austria, 1140
      • SMZ Baumgartner Höhe, Otto-Wagner-Spital und Pflegezentrum /ID# 201776
    • Vienna, Wien, Austria, 1210
      • Krankenhaus Nord - Klinik Floridsdorf /ID# 201768
• Belarus
  • Bobruisk, Belarus, 213825
    • Bobruysk Interdistrict Onco. /ID# 169393
  • Lesnoy, Belarus, 223040
    • State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159383
  • Mogilev, Belarus, 212018
    • Mogilev Reg Clin Oncology Dis /ID# 159384
• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim /ID# 159007
  • Haine Saint Paul, Belgium, 7100
    • Hopital de Jolimont /ID# 159005
  • Montigny-le-tilleul, Belgium, 6110
    • CHU Charleroi (Vesale) /ID# 159008
  • Bruxelles-Capitale
    • Bruxelles, Bruxelles-Capitale, Belgium, 1000
      • CHU Saint-Pierre /ID# 159009
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6000
      • Grand Hôpital de Charleroi /ID# 159006
• Brazil
  • Rio de Janeiro, Brazil, 20231-050
    • Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159658
  • Espirito Santo
    • Cachoeiro de Itapemirim, Espirito Santo, Brazil, 29308-020
      • Hospital Evangelico de Cachoei /ID# 159657
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59075-740
      • Liga Norte Rio Grandense Cont. /ID# 159011
  • Rio Grande Do Sul
    • Ijuí, Rio Grande Do Sul, Brazil, 98700-000
      • Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 159013
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
      • Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159661
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Hospital Sao Lucas da PUCRS /ID# 159662
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784-400
      • Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159012
    • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
      • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159659
• Bulgaria
  • Sofia, Bulgaria, 1527
    • UMHAT Tsaritsa Joanna - ISUL /ID# 159638
  • Sofia, Bulgaria, 1612
    • UMHAT Sv. Ivan Rilski /ID# 159639
• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1Z2
      • British Columbia Cancer Agency /ID# 163721
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • Brampton Civic Hospital /ID# 204425
    • Oshawa, Ontario, Canada, L1G 2B9
      • R.S. McLaughlin Durham Regional /ID# 170870
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret /ID# 170868
    • Windsor, Ontario, Canada, N8W 2X3
      • Windsor Regional Cancer Centre /ID# 170869
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Iucpq-Ul /Id# 159530
• China
  • Nanjing, China, 210029
    • Jiangsu Province Hospital /ID# 205183
  • Xi'an, China, 710038
    • 4th Military Medical Universit /ID# 203986
  • Xi'an, China, 710061
    • First Affiliated Hospital of Xi'an Jiaotong University /ID# 203733
  • Zhengzhou Henan, China, 450008
    • Henan Cancer Hospital /ID# 203983
  • Zhengzhou Henan, China, 450008
    • Henan Cancer Hospital /ID# 204636
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Provincial Cancer Hospital /ID# 204864
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital /Id# 203638
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital /ID# 202886
  • Jilin
    • Changchun, Jilin, China, 130000
      • Jilin Cancer Hosptial /ID# 204060
  • Xinjiang
    • Urumqi, Xinjiang, China, 830000
      • The Affiliated Cancer Hospital of Xinjiang Medical university /ID# 203641
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Yunnan Cancer Hospital /ID# 204911
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer hospital /ID# 204640
    • Jianggan Hangzhou, Zhejiang, China, 310018
      • Sir Run Run Shaw Hospital /ID# 206802
• Croatia
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinicki bolnicki centar Sestre milosrdnice /ID# 159090
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinika za plucne bolesti Jordanovac /ID# 159505
  • Primorsko-goranska Zupanija
    • Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
      • Klinicki bolnicki centar Rijeka /ID# 159504
• Czechia
  • Benesov, Czechia, 256 01
    • Nemocnice Rudolfa a Stefanie /ID# 159655
  • Horovice, Czechia, 268 31
    • Nemocnice Horovice a.s. /ID# 161186
  • Ostrava, Czechia, 703 84
    • Vitkovicka nemocnice a. s. /ID# 161187
  • Plzen, Czechia, 323 00
    • FN Plzen /ID# 204097
  • Pribram, Czechia, 262 04
    • Oblastni Nemocnice Pribram /ID# 159654
  • Praha 4
    • Prague, Praha 4, Czechia, 140 59
      • Thomayerova nemocnice /ID# 159062
• Denmark
  • Hovedstaden
    • Copenhagen Ø, Hovedstaden, Denmark, 2100
      • Rigshospitalet /ID# 158055
    • Herlev, Hovedstaden, Denmark, 2730
      • Herlev Hospital /ID# 158053
  • Nordjylland
    • Aalborg, Nordjylland, Denmark, 9000
      • Aalborg University Hospital /ID# 203737
  • Syddanmark
    • Odense C, Syddanmark, Denmark, 5000
      • Odense Universitets Hospital /ID# 158054
• Estonia
  • Tallinn, Estonia, 10138
    • East Tallinn Central Hospital /ID# 160019
  • Tallinn, Estonia, 13419
    • North Estonian Medical Centre /ID# 159779
• Finland
  • Helsinki, Finland, 00180
    • Docrates Cancer Center /ID# 159591
• France
  • Paris, France, 75970
    • Hopital Tenon /ID# 160541
  • Rennes, France, 35033
    • Hospital Pontchaillou /ID# 160544
  • Strasbourg, France, 67091
    • Nouvel Hopital Civil (NHC) /ID# 204427
  • Toulouse, France, 31059
    • Hopital Larrey /ID# 204290
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13915
      • CHU Hopital Nord /ID# 160543
  • Gironde
    • Pessac CEDEX, Gironde, France, 33604
      • Hopital Haut-Lévêque /ID# 160547
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59000
      • CHU Calmette /ID# 202706
  • Ile-de-France
    • Paris CEDEX 05, Ile-de-France, France, 75248
      • Institut Curie /ID# 207514
  • Rhone
    • Lyon CEDEX 08, Rhone, France, 69373
      • Centre Leon Berard /ID# 160550
  • Val-de-Marne
    • Creteil, Val-de-Marne, France, 94000
      • Centre Hosp Intercommunal de Creteil /ID# 162686
• Germany
  • Berlin, Germany, 10117
    • Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 158783
  • Berlin, Germany, 13125
    • Evangelische Lungenklinik Berl /ID# 158935
  • Gauting, Germany, 82131
    • Asklepios Fachkliniken M. Gaut /ID# 158789
  • Heidelberg, Germany, 69126
    • Thoraxklinik Heidelberg gGmbH /ID# 158871
  • Hemer, Germany, 58675
    • Lungenklinik Hemer /ID# 158790
  • Kassel, Germany, 34125
    • Klinikum Kassel /ID# 158786
  • Löwenstein, Germany, 74245
    • Klinik Loewenstein GmbH /ID# 158870
  • Wangen, Germany, 88239
    • Fachkliniken Wangen /ID# 160779
  • Sachsen-Anhalt
    • Halle (Saale), Sachsen-Anhalt, Germany, 06120
      • KH Martha-Maria Halle Dolau /ID# 158794
• Greece
  • Athens, Greece, 11527
    • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159160
  • Athens, Greece, 18547
    • Metropolitan Hospital /ID# 159157
  • Heraklion, Greece, 71110
    • University General Hospital of Heraklion PA.G.N.I /ID# 202409
  • Ioannina, Greece, 45500
    • University Hospital of Ioannin /ID# 159158
  • Nea Kifisia, Greece, 14564
    • General Oncological Hospital /ID# 159159
  • Thessaloniki, Greece, 54645
    • Euromedica General Clinic /ID# 159156
  • Attiki
    • Cholargos, Attiki, Greece, 15562
      • Metropolitan General Hospital /ID# 202422
• Hong Kong
  • Kowloon, Hong Kong, 852
    • Queen Elizabeth Hospital /ID# 159565
  • Lai Chi Kok, Hong Kong, 999077
    • Princess Margaret Hospital /ID# 162810
  • Tuen Mun, Hong Kong, 999077
    • Tuen Mun Hospital /ID# 162435
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 158955
  • Deszk, Hungary, 6772
    • Csongrad Megyei Mellkasi Beteg /ID# 158952
  • Borsod-Abauj-Zemplen
    • Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
      • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 158962
  • Budapest
    • Budapest XII, Budapest, Hungary, 1122
      • Orszagos Koranyi Pulmonologiai Intezet /ID# 158953
  • Szabolcs-Szatmar-Bereg
    • Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
      • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz - Pulmonologia /ID# 202466
• Ireland
  • Cork, Ireland, T12 E8YV
    • Cork University Hospital /ID# 159715
  • Dublin, Ireland, D04 T6F4
    • St Vincent's University Hosp /ID# 161678
  • Dublin, Ireland, D09 XR63
    • Beaumont Hospital /ID# 159711
  • Limerick, Ireland, V94F858
    • University Hospital Limerick /ID# 159714
  • Waterford, Ireland, X91 ER8E
    • University Hospital Waterford /ID# 159713
  • Dublin
    • Dublin 8, Dublin, Ireland, D08 E9P6
      • St. James's Hospital /ID# 159712
• Israel
  • Be'er Sheva, Israel, 84101
    • Soroka University Medical Center /ID# 159762
  • Be'er Ya'akov, Israel, 70300
    • Assaf Harofeh Medical Center /ID# 201883
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 202336
  • Jerusalem, Israel, 91120
    • Hadassah /ID# 159763
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center /ID# 159761
  • Ramat Gan, Israel, 5239424
    • Sheba Medical Center /ID# 159760
  • Tel-Aviv
    • Petakh Tikva, Tel-Aviv, Israel, 4941492
      • Rabin Medical Center /ID# 159764
    • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 161467
• Italy
  • Arezzo, Italy, 52100
    • AUSL 8 Arezzo Ospedale San Don /ID# 160897
  • Orbassano, Italy, 10043
    • A.O.U. San Luigi Gonzaga /ID# 158916
  • Ravenna, Italy, 48121
    • Ospedale Santa Maria delle Cro /ID# 158911
  • Rome, Italy, 00144
    • IFO Istituto Nazionale Tumori /ID# 158912
  • Emilia-Romagna
    • Meldola, Emilia-Romagna, Italy, 47014
      • IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 160898
  • Lazio
    • Rome, Lazio, Italy, 00128
      • Policlinico Universitario Campus Bio-Medico /ID# 160874
• Japan
  • Akashi, Japan, 673-8558
    • Hyogo Cancer Center /ID# 165138
  • Himeji, Japan, 670-8520
    • National Hospital Organization Himeji Medical Center /ID# 165899
  • Matsusaka-shi MIE, Japan, 515-8544
    • Matsusaka City Hospital /ID# 166156
  • Osaka, Japan, 534-0021
    • Osaka City General Hospital /ID# 165714
  • Sapporo, Japan, 003-0804
    • Hokkaido Cancer Center /ID# 165236
  • Sendai, Japan, 980-0873
    • Sendai Kousei Hospital /ID# 166491
  • Yokohama, Japan, 241-0815
    • Kanagawa Cancer Center /ID# 165814
  • Aichi
    • Nagoya-shi, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital /ID# 164976
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East /ID# 165721
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital /ID# 165722
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Kurume University Hospital /ID# 164595
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital /ID# 165127
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan, 236-0051
      • Kanagawa Cardiovascular and Respiratory Center /ID# 165015
    • Yokohama-shi, Kanagawa, Japan, 2360004
      • Yokohama City University Hospital /ID# 165746
  • Okayama
    • Okayama-shi, Okayama, Japan, 7008607
      • Japanese Red Cross Okayama Hospital /ID# 165157
  • Osaka
    • Hirakata-shi, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital /ID# 165054
    • Osaka-sayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital /ID# 166395
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center /ID# 166272
  • Tokushima
    • Tokushima-shi, Tokushima, Japan, 770-8503
      • Tokushima University Hospital /ID# 166105
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital /ID# 166547
    • Shinagawa-ku, Tokyo, Japan
      • Showa University Hospital /ID# 165575
  • Wakayama
    • Wakayama-shi, Wakayama, Japan, 641-8510
      • Wakayama Medical University /ID# 165946
• Korea, Republic of
  • Cheongju-si, Korea, Republic of, 28644
    • Chungbuk National University /ID# 159300
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital /ID# 159297
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center /ID# 159299
  • Busan Gwang Yeogsi
    • Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
      • Dong-A University Hospital /ID# 159305
  • Gyeonggido
    • Seongnam si, Gyeonggido, Korea, Republic of, 13496
      • CHA Bundang Medical center CHA University /ID# 161281
  • Seoul Teugbyeolsi
    • Daegu, Seoul Teugbyeolsi, Korea, Republic of, 41404
      • Kyungpook National University Chilgok Hospital /ID# 159301
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
      • Samsung Medical Center /ID# 159304
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
      • Korea University Guro Hospital /ID# 159302
• Latvia
  • Riga, Latvia, LV-1002
    • Pauls Stradins Clinical /ID# 158715
  • Riga, Latvia, LV-1079
    • Riga East Clinical University /ID# 158716
• Lithuania
  • Klaipeda, Lithuania, LT-92288
    • Klaipeda University Hospital /ID# 160018
  • Vilnius, Lithuania, 08660
    • National Cancer Institute /ID# 160017
  • Kaunas
    • Kovno, Kaunas, Lithuania, 50009
      • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 160016
• Mexico
  • Ciudad de México, Mexico, 03810
    • Health Pharma professional Ser /ID# 160734
  • Michoacan
    • Morelia, Michoacan, Mexico, 58260
      • Centro de Investigación Clinica Chapultepec /ID# 160965
• Netherlands
  • Amersfoort, Netherlands, 3813 TZ
    • Meander Medisch Centrum /ID# 159064
  • Arnhem, Netherlands, 6815 AD
    • Rijnstate /ID# 159063
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis /ID# 159065
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis /ID# 158082
  • Maastricht, Netherlands, 6229 HX
    • Maastricht Universitair Medisch Centrum /ID# 161669
  • S Hertogenbosch, Netherlands, 5223 GZ
    • Jeroen Bosch Ziekenhuis /ID# 158081
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht /ID# 158083
• Norway
  • Oslo, Norway, 0379
    • Radiumhospitalet, OUS /ID# 159574
  • Stavanger, Norway, 4011
    • Stavanger Universitetssykehus /ID# 159575
  • Akershus
    • Nordbyhagen, Akershus, Norway, 1474
      • Akershus universitetssykehus /ID# 201682
  • Buskerud
    • Drammen, Buskerud, Norway, 3004
      • Drammen Sykehus /ID# 159572
  • Hordaland
    • Bergen, Hordaland, Norway, 5021
      • Haukeland University Hospital /ID# 159573
  • Sor-Trondelag
    • Trondheim, Sor-Trondelag, Norway, 7006
      • St. Olavs Hospital HF /ID# 163110
• Poland
  • Bytom, Poland, 41-902
    • Wojewodzki Szpital Specjalisty /ID# 159603
  • Gdynia, Poland, 81-519
    • Szpitale Pomorskie Sp. z o.o /ID# 159605
  • Podkarpackie
    • Rzeszów, Podkarpackie, Poland, 35-021
      • Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 159604
• Portugal
  • Lisboa, Portugal, 1099-023
    • IPO Lisboa FG, EPE /ID# 159949
  • Lisbon, Portugal, 1500-650
    • Hospital da Luz, SA /ID# 159954
  • Matosinhos, Portugal, 4464-513
    • Unidade Local Saude Matosinhos /ID# 159950
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto EPE /ID# 203582
  • Porto, Portugal, 4100-180
    • Hospital CUF Porto /ID# 159955
  • Porto, Portugal, 4200-072
    • IPO Porto FG, EPE /ID# 159956
  • Lisboa
    • Lisbon, Lisboa, Portugal, 1769-001
      • Centro Hospitalar Lisboa Norte, EPE /ID# 159957
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Arkhangelsk clinical oncology /ID# 159367
  • Kaluga, Russian Federation, 284007
    • Kaluga Regional Clinical Oncol /ID# 160180
  • Omsk, Russian Federation, 644013
    • Clinical Onco Dispensary /ID# 159365
  • Pushkin, Russian Federation, 196603
    • PMI Euromedservice /ID# 159369
  • Pyatigorsk, Russian Federation, 357532
    • LLC Novaya Clinica /ID# 205523
  • Saint Petersburg, Russian Federation, 197343
    • OOO Centre of Palliative Medicine De Vita /ID# 206855
  • Saransk, Russian Federation, 430005
    • Ogarev Mordovia State Univ /ID# 205742
  • Smolensk, Russian Federation, 214009
    • Smolensk Regional Onc Clin Dis /ID# 159372
  • St. Petersburg, Russian Federation, 197342
    • LLC BioEq Ltd. /ID# 159368
  • St. Petersburg, Russian Federation, 197758
    • N.N. Petrov Research Inst Onc /ID# 159370
  • Moskovskaya Oblast
    • Moscow, Moskovskaya Oblast, Russian Federation, 115478
      • National Medical Research Cntr /ID# 169885
• Serbia
  • Belgrade, Serbia, 11000
    • Institut za onkologiju i radio /ID# 160904
  • Sremska Kamenica, Serbia, 21204
    • Institute For Pulmonary Diseas /ID# 164250
  • Beograd
    • Belgrade, Beograd, Serbia, 11000
      • Clinical Center Serbia /ID# 160902
    • Belgrade, Beograd, Serbia, 11080
      • Clin Hosp Ctr Bezanijska Kosa /ID# 160903
  • Nisavski Okrug
    • NIS, Nisavski Okrug, Serbia, 18000
      • Clinical Center of Nis /ID# 160905
• South Africa
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa, 6045
      • Cancercare Langenhoven Drive Oncology Centre /ID# 159126
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0044
      • Dr Albert, Bouwer and Jordaan Incorporated /ID# 158873
    • Pretoria, Gauteng, South Africa, 0181
      • Mary Potter Oncology Centre /ID# 158877
  • Kwazulu-Natal
    • Durban, Kwazulu-Natal, South Africa, 4091
      • The Oncology Centre /ID# 158872
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7570
      • Cape Town Oncology Trials /ID# 201311
    • George, Western Cape, South Africa, 6530
      • Cancercare Outeniqua Oncology Unit /ID# 200689
• Spain
  • Barcelona, Spain, 08003
    • Hospital Parc de Salut del Mar /ID# 159690
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 159708
  • Madrid, Spain, 28040
    • Hospital Clinico Universitario San Carlos /ID# 159706
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz /ID# 159693
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 159692
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa /ID# 159709
  • A Coruna
    • A Coruña, A Coruna, Spain, 15006
      • Hospital Teresa Herrera - CHUAC /ID# 164368
  • Malaga
    • Málaga, Malaga, Spain, 29010
      • Hospital Regional de Malaga /ID# 164371
• Sweden
  • Linkoping, Sweden, 581 85
    • University Hospital Linkoping /ID# 159046
  • Solna, Sweden, 17176
    • Karolinska Univ Sjukhuset /ID# 159649
  • Uppsala, Sweden, 75185
    • Uppsala University Hospital /ID# 159052
  • Varmlands Lan
    • Karlstad, Varmlands Lan, Sweden, 651 85
      • Centralsjukhuset, Karlstad /ID# 163451
  • Vastra Gotalands Lan
    • Göteborg, Vastra Gotalands Lan, Sweden, 413 46
      • Sahlgrenska US Gbg /ID# 159524
• Switzerland
  • Basel, Switzerland, 4031
    • Universitaetsspital Basel /ID# 160605
  • Luzern, Switzerland, 6000
    • Luzerner Kantonsspital /ID# 160607
  • Winterthur, Switzerland, 8401
    • Kantonsspital Winterthur /ID# 161379
  • Geneve
    • Genève, Geneve, Switzerland, 1205
      • Hopitaux Universitaires de Geneve /ID# 160603
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen /ID# 160604
• Taiwan
  • Dalin Township, Taiwan, 622
    • Dalin Tzu Chi General Hospital /ID# 158983
  • Kaohsiung, Taiwan, 80708
    • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 158798
  • Taichung City, Taiwan, 40705
    • Taichung Veterans General Hosp /ID# 159047
  • Taipei City, Taiwan, 11217
    • Taipei Veterans General Hosp /ID# 203699
  • Taichung
    • Taichung City, Taichung, Taiwan, 40447
      • China Medical University Hosp /ID# 158981
  • Tainan
    • Tainan City, Tainan, Taiwan, 70403
      • National Cheng Kung University Hospital /ID# 158799
  • Taipei
    • Taipei City, Taipei, Taiwan, 10002
      • National Taiwan Univ Hosp /ID# 159049
    • Taipei City, Taipei, Taiwan, 11490
      • Tri-Service General Hospital /ID# 158980
• Turkey
  • Ankara, Turkey, 06280
    • Ataturk Gogus Hastalikl /ID# 159556
  • Antalya, Turkey, 07059
    • Akdeniz Universitesi Tip Fakul /ID# 160791
  • Istanbul, Turkey, 34093
    • Bezmi alem Vakif Universitesi /ID# 202267
  • Istanbul, Turkey, 34722
    • Istanbul Medeniyet Universites /ID# 200126
  • Izmir, Turkey, 35040
    • Ege University Medical Faculty /ID# 159243
  • Izmir, Turkey, 35110
    • Dr. Suat Seren Gogus Has /ID# 159244
  • Malatya, Turkey, 44280
    • Inonu University /ID# 159245
  • Ankara
    • Altindağ, Ankara, Turkey, 06250
      • Hacettepe University Medical Faculty /ID# 159242
  • Kayseri
    • Melikgazi, Kayseri, Turkey, 38030
      • Erciyes University Medical Fac /ID# 202269
• Ukraine
  • Chernivtsi, Ukraine, 58013
    • Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 159864
  • Dnipro, Ukraine, 49102
    • Municipal institution Multifie /ID# 159130
  • Kharkiv, Ukraine, 61070
    • Regional Center of Oncology /ID# 159132
  • Kropyvnytskyi, Ukraine, 25006
    • PE PMC Acinus, Medical and Diagnostic Center /ID# 165543
  • Lutsk, Ukraine, 43018
    • Volyn Regional Medical Oncology Centre /ID# 159133
  • Uzhhorod, Ukraine, 88000
    • Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159865
  • Zaporizka Oblast
    • Zaporizhzhia, Zaporizka Oblast, Ukraine, 69040
      • CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159131
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Medical Centre /ID# 162899
  • Bournemouth, United Kingdom, BH7 7DW
    • The Royal Bournemouth Hospital /ID# 159039
  • Colchester, United Kingdom, CO4 5JL
    • Colchester General Hospital /ID# 159042
  • Hereford, United Kingdom, HR1 2ER
    • Hereford County Hospital /ID# 159038
  • London, United Kingdom, SW17 0QT
    • St. George's Healthcare NHS /ID# 202416
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital /ID# 161399
  • Maidstone, United Kingdom, ME16 9QQ
    • Maidstone Hospital /ID# 159043
  • Manchester, United Kingdom, M20 4BX
    • Christie NHS Foundation Trust /ID# 159037
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 159044
  • Torquay, United Kingdom, TQ2 7AA
    • Torbay Hospital - So Devon HC /ID# 159041
  • Gloucestershire
    • Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
      • Cheltenham General Hospital /ID# 169096
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Clearview Cancer Institute /ID# 156699
    • Mobile, Alabama, United States, 36604-3302
      • University of South Alabama /ID# 160975
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703-4005
      • Highlands Oncology Group /ID# 156722
  • California
    • Greenbrae, California, United States, 94904
      • Marin Cancer Care /ID# 159207
    • La Jolla, California, United States, 92093
      • Ucsd /Id# 157764
    • Los Angeles, California, United States, 90017
      • LA Hem-Oncology Med Group /ID# 156717
    • Palo Alto, California, United States, 94304-1207
      • Palo Alto Veterans Institute for Research /ID# 203695
    • Santa Rosa, California, United States, 95403
      • St Jude Hospital dba St Joseph /ID# 156526
    • Whittier, California, United States, 90603
      • Icri /Id# 157765
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Kaiser Permanente Lone Tree /ID# 159331
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Health Service /ID# 159212
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital /ID# 156716
    • Gainesville, Florida, United States, 32610
      • University of Florida - Archer /ID# 155799
    • Hollywood, Florida, United States, 33021-5421
      • Memorial Cancer Institute /ID# 156673
    • Hollywood, Florida, United States, 33021-5421
      • Memorial Cancer Institute /ID# 164052
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida - Southpoint /ID# 156595
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Georgia Cancer Center /ID# 201894
    • Newnan, Georgia, United States, 30265
      • Southeastern Regional Medical /ID# 163064
  • Idaho
    • Boise, Idaho, United States, 83712
      • St. Luke's Mountain States Tumor Institute - Boise /ID# 156691
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem - Evanston Hospital /ID# 156664
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hosp /ID# 156685
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Goshen Center for Cancer Care /ID# 156682
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • Ashland-Bellefonte Cancer Ctr /ID# 202901
    • Louisville, Kentucky, United States, 40202
      • University of Louisville /ID# 156683
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70836-6455
      • Ochsner Clinic Foundation /ID# 159136
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System /ID# 156712
    • Lansing, Michigan, United States, 48912
      • Sparrow Regional Cancer Center, Sparrow Health System /ID# 156590
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 160181
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • MidAmerica Division, Inc. /ID# 163530
  • Montana
    • Billings, Montana, United States, 59101-0733
      • Billings Clinic /ID# 201788
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Nebraska Hematology Oncology /ID# 156534
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • MD Anderson Cancer Center at Cooper - Camden /ID# 156681
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center /ID# 201845
    • Lake Success, New York, United States, 11042
      • Northwell Health - Monter Cancer Center /ID# 159252
    • New York, New York, United States, 10029
      • Icahn School of Med Mt. Sinai /ID# 159210
    • Stony Brook, New York, United States, 11794-8183
      • Stony Brook University Hospital /ID# 159272
  • North Carolina
    • Durham, North Carolina, United States, 27710-3000
      • Duke University Medical Center /ID# 156706
    • Greensboro, North Carolina, United States, 27403
      • Cone Health /ID# 156689
    • Greensboro, North Carolina, United States, 27403
      • Cone Health /ID# 163612
    • Greenville, North Carolina, United States, 27834
      • Eastern Carolina University /ID# 159264
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research /ID# 156667
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente, NW /ID# 201793
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107-4414
      • Thomas Jefferson University /ID# 156719
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh HealthcareSystem /ID# 159284
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital /ID# 160834
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404-1108
      • Sarah Cannon Research Institute-Chattanooga /ID# 202933
    • Knoxville, Tennessee, United States, 37916
      • Thompson Cancer Survival Ctr /ID# 202460
    • Nashville, Tennessee, United States, 37203-1632
      • Tennessee Oncology-Nashville Centennial /ID# 161168
  • Texas
    • Austin, Texas, United States, 78701
      • Univ Medical Ctr Brackenridge /ID# 155798
    • Dallas, Texas, United States, 75235
      • Parkland Health and Hosp Syste /ID# 170933
    • Dallas, Texas, United States, 75390-7208
      • UT Southwestern Medical Center /ID# 157848
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital - Scurlock Tower /ID# 202323
  • Washington
    • Spokane, Washington, United States, 99208
      • Medical Oncology Associates /ID# 156715
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia Univ School Med /ID# 156687

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS in All Randomized Participants	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, 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	The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.	Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2017
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Cancer; Rovalpituzumab tesirine; Small Cell Lung Cancer (SCLC); first-line chemotherapy; Delta-like protein 3 (DLL3); Extensive-Stage Small Cell Lung Cancer (ED SCLC); Platinum-Based Chemotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Immunoconjugates
• Other Study ID Numbers: M16-298; 2016-003503-64 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• 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