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) (TAHOE)

A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for Subjects With Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) Who Have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)

The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: Rovalpituzumab tesirine; Drug: Dexamethasone; Drug: Topotecan

• Study Type: Interventional
• Enrollment (Actual): 444
• Phase: Phase 3

Expanded Access

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

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Blacktown Hospital /ID# 158907
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital /ID# 158855
    • Wollongong, New South Wales, Australia, 2500
      • Southern Medical Day Care Ctr /ID# 158853
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital /ID# 158897
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • Ballarat Health Service /ID# 158904
    • Heidelberg, Victoria, Australia, 3084
      • Austin Hospital /ID# 158898
• Belarus
  • Bobruisk, Belarus, 213825
    • Bobruysk Interdistrict Onco. /ID# 169394
  • Lesnoy, Belarus, 223040
    • State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159325
  • Mogilev, Belarus, 212018
    • Mogilev Reg. Oncologic dispe /ID# 159326
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques universitaires Saint /ID# 158751
  • Haine Saint Paul, Belgium, 7100
    • Hopital de Jolimont /ID# 159755
  • Leuven, Belgium, 3000
    • UZ Leuven /ID# 158752
  • Liege, Belgium, 4000
    • CHU de Liege Sart Tilman /ID# 158753
  • Montigny-le-tilleul, Belgium, 6110
    • CHU Charleroi (Vesale) /ID# 159756
  • Bruxelles-Capitale
    • Bruxelles, Bruxelles-Capitale, Belgium, 1000
      • CHU Saint-Pierre /ID# 159521
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6000
      • Grand Hôpital de Charleroi /ID# 158748
• Brazil
  • Rio de Janeiro, Brazil, 20231-050
    • Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159665
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59075-740
      • Liga Norte Rio Grandense Cont. /ID# 159015
  • Rio Grande Do Sul
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
      • Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159668
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784-400
      • Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159017
    • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
      • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159666
• Bulgaria
  • Sofia, Bulgaria, 1527
    • UMHAT Tsaritsa Joanna - ISUL /ID# 159641
  • Sofia, Bulgaria, 1612
    • UMHAT Sv. Ivan Rilski /ID# 159642
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute /ID# 159519
  • Ontario
    • Hamilton, Ontario, Canada, L8V 1C3
      • Juravinski Cancer Clinic /ID# 159514
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Hopital du Sacre Coeur Montreal /ID# 159515
    • Quebec City, Quebec, Canada, G1R 2J6
      • CHU de Quebec-Universite Laval /ID# 159093
    • Rimouski, Quebec, Canada, G5L 5T1
      • Cisss Du Bas-Saint-Laurent Hopital Regional de Rimouski /Id# 208931
• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Jilin Cancer Hosptial /ID# 204059
• Croatia
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinicki bolnicki centar Sestre milosrdnice /ID# 158811
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Klinika za plucne bolesti Jordanovac /ID# 159502
  • Primorsko-goranska Zupanija
    • Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
      • Klinicki bolnicki centar Rijeka /ID# 159501
• Czechia
  • Benesov, Czechia, 256 01
    • Nemocnice Rudolfa a Stefanie /ID# 159652
  • Horovice, Czechia, 268 31
    • Nemocnice Horovice a.s. /ID# 161191
  • Liberec, Czechia, 602 00
    • Krajska nemocnice Liberec a.s. /ID# 159653
  • Praha 4
    • Prague, Praha 4, Czechia, 140 59
      • Thomayerova nemocnice /ID# 159061
  • Pribram
    • Nová Ves pod Pleší, Pribram, Czechia, 262 04
      • Nemocnice Na Plesi s.r.o. /ID# 161190
• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet, Finsen Centre /ID# 158051
  • Hovedstaden
    • Herlev, Hovedstaden, Denmark, 2730
      • Herlev Hospital /ID# 158049
  • Syddanmark
    • Odense C, Syddanmark, Denmark, 5000
      • Odense Universitets Hospital /ID# 158050
• France
  • Paris, France, 75020
    • Assistance Publique- Hopitaux /ID# 160552
  • Rennes, France, 35033
    • Hospital Pontchaillou /ID# 160555
  • Gironde
    • Pessac CEDEX, Gironde, France, 33604
      • Hopital Haut-Lévêque /ID# 160558
  • Provence-Alpes-Cote-d Azur
    • Marseille, Provence-Alpes-Cote-d Azur, France, 13105
      • Assis.Publique-Hopital Nord /ID# 160554
  • Rhone
    • Lyon CEDEX 08, Rhone, France, 69373
      • Centre Leon Berard /ID# 160561
  • Val-de-Marne
    • Creteil, Val-de-Marne, France, 94000
      • Centre Hosp Intercommunal de Creteil /ID# 162684
• Germany
  • Berlin, Germany, 13125
    • Evangelische Lungenklinik Berl /ID# 159168
  • Gauting, Germany, 82131
    • Asklepios Fachkliniken M. Gaut /ID# 158791
  • Grosshansdorf, Germany, 22927
    • Lungen Clinic Grosshansdorf /ID# 158770
  • Heidelberg, Germany, 69126
    • Thoraxklinik Heidelberg gGmbH /ID# 159169
  • Kassel, Germany, 34125
    • Klinikum Kassel /ID# 158788
  • Löwenstein, Germany, 74245
    • Klinik Loewenstein GmbH /ID# 159167
  • Sachsen-Anhalt
    • Halle (Saale), Sachsen-Anhalt, Germany, 06120
      • KH Martha-Maria Halle Dolau /ID# 158796
• Greece
  • Athens, Greece, 11527
    • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159165
  • Athens, Greece, 18547
    • Metropolitan Hospital /ID# 159162
  • Ioannina, Greece, 45500
    • University Hospital of Ioannin /ID# 159163
  • Thessaloniki, Greece, 54645
    • Euromedica General Clinic /ID# 159161
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 161197
  • Budapest, Hungary, 1122
    • Orszagos Koranyi Pulmonologiai Intezet /ID# 158967
  • Debrecen, Hungary, 4032
    • Dup_Debreceni Egyetem Klinikai Központ /ID# 161209
  • Farkasgyepu, Hungary, 8582
    • Veszprem Megyei Tuedoegyogyint /ID# 162607
  • Gyor, Hungary, 9023
    • Petz Aladar Megyei Oktato Korh /ID# 158978
  • Matrahaza, Hungary, 3233
    • Matrai Gyogyintezet /ID# 158979
  • Pest
    • Budapest, Pest, Hungary, 2045
      • Torokbalinti Tudogyogyintezet /ID# 207053
• Italy
  • Arezzo, Italy, 52100
    • AUSL 8 Arezzo Ospedale San Don /ID# 160967
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia /ID# 158942
  • Orbassano, Italy, 10043
    • A.O.U. San Luigi Gonzaga /ID# 158945
  • Ravenna, Italy, 48121
    • Ospedale Santa Maria delle Cro /ID# 158940
  • Rome, Italy, 00144
    • IFO Istituto Nazionale Tumori /ID# 158941
• Japan
  • Matsusaka-shi MIE, Japan, 515-8544
    • Matsusaka City Hospital /ID# 166126
  • Yokohama, Japan, 241-0815
    • Kanagawa Cancer Center /ID# 165816
  • Aichi
    • Nagoya-shi, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital /ID# 164975
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East /ID# 165726
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital /ID# 165723
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Kurume University Hospital /ID# 164586
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 003-0804
      • Hokkaido Cancer Center /ID# 165237
  • Hyogo
    • Akashi-shi, Hyogo, Japan, 673-8558
      • Hyogo Cancer Center /ID# 165125
    • Himeji-shi, Hyogo, Japan, 670-0012
      • Himeji Medical Center /ID# 165893
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 920-8641
      • Duplicate_Kanazawa University Hospital /ID# 165129
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital /ID# 165748
    • Yokohama-shi, Kanagawa, Japan, 236-0051
      • Kanagawa Cardiovascular and Respiratory Center /ID# 164374
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 980-0873
      • Sendai Kousei Hospital /ID# 166061
  • Okayama
    • Okayama-shi, Okayama, Japan, 700-8607
      • Japanese Red Cross Okayama Hospital /ID# 165156
  • Osaka
    • Hirakata-shi, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital /ID# 165055
    • Osaka-sayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital /ID# 166394
    • Osaka-shi, Osaka, Japan, 534-0021
      • Osaka City General Hospital /ID# 165717
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center /ID# 166466
  • Tokushima
    • Tokushima-shi, Tokushima, Japan, 770-8503
      • Tokushima University Hospital /ID# 165812
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital /ID# 166768
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital Of JFCR /ID# 166249
    • Shinagawa-ku, Tokyo, Japan, 142-0054
      • Duplicate_Showa University Hospital /ID# 165574
  • Wakayama
    • Wakayama-shi, Wakayama, Japan, 641-8510
      • Wakayama Medical University /ID# 166032
• Korea, Republic of
  • Cheongju-si, Korea, Republic of, 28644
    • Chungbuk National University /ID# 159291
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center /ID# 159290
  • Busan Gwang Yeogsi
    • Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
      • Dong-A University Hospital /ID# 159296
  • Gyeonggido
    • Seongnam si, Gyeonggido, Korea, Republic of, 13496
      • CHA Bundang Medical center CHA University /ID# 204416
  • Jeonranamdo
    • Gwangju, Jeonranamdo, Korea, Republic of, 61469
      • Chonnam National University Hospital /ID# 159294
  • Seoul Teugbyeolsi
    • Daegu, Seoul Teugbyeolsi, Korea, Republic of, 41404
      • Kyungpook National University Chilgok Hospital /ID# 159292
    • Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
      • Yonsei University Health System, Severance Hospital /ID# 159288
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
      • Korea University Guro Hospital /ID# 159293
• Latvia
  • Riga, Latvia, LV-1002
    • Pauls Stradins Clinical /ID# 158713
  • Riga, Latvia, LV-1079
    • Riga East Clinical University /ID# 158714
• Mexico
  • Del. Benito Juárez, Mexico, 03810
    • Health Pharma Professional Research S.A de C.V /ID# 160020
  • Michoacan
    • Morelia, Michoacan, Mexico, 58260
      • Centro de Investigación Clinica Chapultepec /ID# 161000
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen /ID# 158088
  • Harderwijk, Netherlands, 3844 DG
    • Ziekenhuis St. Jansdal /ID# 158652
  • Zwolle, Netherlands, 8025 AB
    • Isala /ID# 158653
• Poland
  • Gdansk, Poland, 80-219
    • Copernicus PL Sp. z o. o., WCO /ID# 160538
  • Gdynia, Poland, 81-519
    • Szpitale Pomorskie Sp. z o.o /ID# 160536
  • Podkarpackie
    • Rzeszów, Podkarpackie, Poland, 35-021
      • Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 160537
• Portugal
  • Lisboa, Portugal, 1099-023
    • IPO Lisboa FG, EPE /ID# 158995
  • Lisbon, Portugal, 1500-650
    • Hospital da Luz, SA /ID# 158996
  • Matosinhos, Portugal, 4464-513
    • Unidade Local Saude Matosinhos /ID# 158682
  • Porto, Portugal, 4100-180
    • Hospital CUF Porto /ID# 158685
  • Porto, Portugal, 4200-072
    • IPO Porto FG, EPE /ID# 158686
  • Lisboa
    • Lisbon, Lisboa, Portugal, 1769-001
      • Centro Hospitalar Lisboa Norte, EPE /ID# 158687
• Romania
  • Alba, Romania, 510077
    • Spitalul Judetean de Urgenta A /ID# 160846
  • Dolj
    • Craiova, Dolj, Romania, 200347
      • S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 160847
  • Timis
    • Timisoara, Timis, Romania, 300166
      • Oncocenter Oncologie Clinica S /ID# 160848
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Arkhangelsk clinical oncology /ID# 159309
  • Kaluga, Russian Federation, 284007
    • Kaluga Regional Clinical Oncol /ID# 160179
  • Omsk, Russian Federation, 644013
    • Clinical Onco Dispensary /ID# 159307
  • Pushkin, Russian Federation, 196603
    • PMI Euromedservice /ID# 159311
  • Smolensk, Russian Federation, 214009
    • Smolensk Regional Onc Clin Dis /ID# 159314
  • St. Petersburg, Russian Federation, 197342
    • LLC BioEq Ltd. /ID# 159310
  • St. Petersburg, Russian Federation, 197758
    • N.N. Petrov Research Inst Onc /ID# 159312
  • Moskovskaya Oblast
    • Moscow, Moskovskaya Oblast, Russian Federation, 115478
      • National Medical Research Cntr /ID# 207436
  • Stavropol Skiy Kray
    • Pyatigorsk, Stavropol Skiy Kray, Russian Federation, 357500
      • LLC Novaya Klinika /ID# 205539
• Serbia
  • Belgrade, Serbia, 11000
    • Institut za onkologiju i radio /ID# 160058
  • Belgrade, Serbia, 11000
    • Klinicki centar Srbije /ID# 160024
  • Sremska Kamenica, Serbia, 21204
    • Institute For Pulmonary Diseas /ID# 158813
  • Nisavski Okrug
    • NIS, Nisavski Okrug, Serbia, 18000
      • Clinical Center of Nis /ID# 160059
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital /ID# 158802
  • Singapore, Singapore, 169610
    • National Cancer Ctr Singapore /ID# 158803
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic /ID# 159031
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau /ID# 159028
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon /ID# 159025
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro /ID# 159024
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia /ID# 159027
• Sweden
  • Uppsala, Sweden, 75185
    • Uppsala University Hospital /ID# 159050
  • Vastra Gotalands Lan
    • Göteborg, Vastra Gotalands Lan, Sweden, 413 46
      • Sahlgrenska US Gbg /ID# 159534
• Taiwan
  • Taichung City, Taiwan, 40705
    • Taichung Veterans General Hosp /ID# 158866
  • Tainan
    • Tainan City, Tainan, Taiwan, 70403
      • National Cheng Kung University Hospital /ID# 158844
  • Taipei
    • Taipei City, Taipei, Taiwan, 100
      • National Taiwan University Hospital /ID# 158865
    • Taipei City, Taipei, Taiwan, 11490
      • Tri-Service General Hospital /ID# 158985
• Turkey
  • Battalgazi/malatya, Turkey, 44280
    • Inonu Universitesi Turgut Ozal /ID# 159241
  • Izmir, Turkey, 35040
    • Ege University Medical Faculty /ID# 159239
  • Izmir, Turkey, 35110
    • Dr. Suat Seren Gogus Has /ID# 159240
  • Kecioren/ankara, Turkey, 06280
    • Ataturk Gogus Hastaliklari ve /ID# 160056
  • Ankara
    • Altindağ, Ankara, Turkey, 06250
      • Hacettepe University Medical Faculty /ID# 159238
• Ukraine
  • Chernivtsi, Ukraine, 58013
    • Municipal institution /ID# 159867
  • Dnipro, Ukraine, 49102
    • Municipal institution Multifie /ID# 159121
  • Kharkiv, Ukraine, 61070
    • Regional Center of Oncology /ID# 159123
  • Kropyvnytskyi, Ukraine, 25006
    • PE PMC Acinus, Medical and Diagnostic Center /ID# 159125
  • Kryviy RIH, Ukraine, 50048
    • ME Kryviy Rih Oncology Dispensary /ID# 159119
  • Lutsk, Ukraine, 43018
    • Volyn Regional Medical Oncology Centre /ID# 159124
  • Uzhhorod, Ukraine, 88000
    • Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159868
  • Zaporizka Oblast
    • Zaporizhzhia, Zaporizka Oblast, Ukraine, 69040
      • CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159122
• United Kingdom
  • Boston, United Kingdom, PE21 9QS
    • United Lincolnshire Hospitals /ID# 159579
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital /ID# 159582
  • Manchester, United Kingdom, M20 4BX
    • Christie NHS Foundation Trust /ID# 159099
  • Middlesborough, United Kingdom, TS4 3BW
    • James Cook University Hospital /ID# 159583
  • Preston, United Kingdom, PR2 9HT
    • Royal Preston Hospital /ID# 159578
  • London, City Of
    • London, London, City Of, United Kingdom, SE1 9RT
      • Guy's and St Thomas' NHS Found /ID# 159581
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Clearview Cancer Institute /ID# 155873
    • Mobile, Alabama, United States, 36604
      • Mitchell Cancer Institute /ID# 158151
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Carti /Id# 156982
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group /ID# 155902
  • California
    • Beverly Hills, California, United States, 90211
      • Cedars-Sinai Medical Center /ID# 157102
    • La Jolla, California, United States, 92093
      • Moore UC San Diego Cancer Center /ID# 156965
    • Los Angeles, California, United States, 90017
      • Los Angeles Hematology Oncolog /ID# 155879
    • Sacramento, California, United States, 95817
      • University of California, Davis Comprehensive Cancer Center /ID# 157001
    • Santa Rosa, California, United States, 95403
      • St Jude Hospital dba St Joseph /ID# 155899
    • Whittier, California, United States, 90603
      • Icri /Id# 157090
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Health Service /ID# 158171
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida - Southpoint /ID# 155828
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Georgia Cancer Center /ID# 160206
  • Idaho
    • Meridian, Idaho, United States, 83712
      • St. Luke's Mountain States Tumor Institute - Meridian /ID# 164550
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem - Evanston Hospital /ID# 157054
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hosp /ID# 155871
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Goshen Center for Cancer Care /ID# 155946
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville /ID# 155947
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70836-6455
      • Ochsner Clinic Foundation /ID# 160807
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute /ID# 160210
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Sparrow Regional Cancer Center, Sparrow Health System /ID# 157021
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Nebraska Hematology Oncology /ID# 155900
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research /ID# 155920
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University /ID# 157055
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Ctr /ID# 164403
  • Texas
    • Austin, Texas, United States, 78701
      • Univ Medical Ctr Brackenridge /ID# 156967
    • Dallas, Texas, United States, 75390-7208
      • UT Southwestern Medical Center /ID# 158150
  • Vermont
    • Burlington, Vermont, United States, 05401-1473
      • University of Vermont Medical Center /ID# 162317
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington /ID# 162626
    • Spokane, Washington, United States, 99208
      • Medical Oncology Associates /ID# 156856
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia Univ School Med /ID# 155872

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participant must have histologically or cytologically confirmed advanced or metastatic Small Cell Lung Cancer (SCLC) with documented first disease progression during or following front-line platinum-based systemic regimen
• Tumor must have high Delta-like protein 3 (DLL3) expression defined as having ≥ 75% tumor cells staining positive according to the VENTANA DLL3 (SP347) IHC Assay.
• Participant must have measurable disease, as defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Participant must have recovery to Grade 0 or 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration.

Exclusion Criteria:

• Participant has a documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class (NYHA) III - IV within 6 months prior to their first dose of study drug.
• Participant has known leptomeningeal metastases.
• Participant has received more than one prior systemic therapy regimen for SCLC.
• Participant had a serious infection within 2 weeks prior to randomization, including any Grade 3 or higher viral, bacterial, or fungal infection.
• Participant has a history of active malignancies other than SCLC within the past 2 years prior to study entry, with the exception of in situ cancer which was curatively treated.
• Participant had prior exposure to topotecan, irinotecan or any other topoisomerase I inhibitors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rovalpituzumab tesirine; Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted. Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered.	Drug: Rovalpituzumab tesirine; Powder for solution for infusion in vials.; Other Names: Rova-T; Drug: Dexamethasone; Oral tablet.
Active Comparator: Topotecan; Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m^2 on Days 1 to 5 of each 21-day cycle.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of death from any cause. Participants were censored at the last date they were documented alive. After the End of treatment, survival information was collected at approximately 6-week intervals (or as requested by sponsor to support data analysis) continuing until the endpoint of death, the participant became lost to follow-up, AbbVie terminated the study, or until 12 February 2020. Calculated using the Kaplan-Meier product-limit method.	From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the number of months from the date of randomization until the date of first progression or the date of a participant's death, whichever occurs first. If a participant neither experienced disease progression nor died, then the participant's data were censored at the last date of radiographic assessment that they were documented to be progression free. Calculated using the Kaplan-Meier product-limit method. Radiographic tumor assessments for response were conducted by CT scanning according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Progressive Disease (PD) was defined as at least a 20% increase in the size of target lesions and an absolute increase of at least 5 mm taking as reference the smallest lesion size recorded since the treatment started (baseline or after), or the appearance of one or more new lesions.	From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.
Change From Baseline of the Physical Functioning Scale Score in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL) at Week 7	The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The score of 'physical functioning scale' score ranges from 0 (very poor) to 100 (excellent).	Baseline, Week 7
Objective Response Rate (ORR)	ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST version 1.1. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR or PR, including those who did not have post-baseline radiological assessments were considered non-responders. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.
Clinical Benefit Rate (CBR)	CBR is defined as percentage of participants whose best overall response is CR, PR, or stable disease (SD) according to RECIST version 1.1. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR, PR, or SD, including those who did not have post-baseline radiological assessments were considered as experiencing no clinical benefit. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.	Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.
Duration of Objective Response (DOR)	DOR is defined as the time between the date of first response (CR or PR, whichever is recorded first) to the date of the first documented tumor progression (per RECIST version 1.1) or death due to any cause, whichever comes first. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR or PR, including those who did not have post-baseline radiological assessments were considered non-responders. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively.

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.
• Morgensztern D, Besse B, Greillier L, Santana-Davila R, Ready N, Hann CL, Glisson BS, Farago AF, Dowlati A, Rudin CM, Le Moulec S, Lally S, Yalamanchili S, Wolf J, Govindan R, Carbone DP. Efficacy and Safety of Rovalpituzumab Tesirine in Third-Line and Beyond Patients with DLL3-Expressing, Relapsed/Refractory Small-Cell Lung Cancer: Results From the Phase II TRINITY Study. Clin Cancer Res. 2019 Dec 1;25(23):6958-6966. doi: 10.1158/1078-0432.CCR-19-1133. Epub 2019 Sep 10.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Actual): February 12, 2020
• Study Completion (Actual): February 12, 2020

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 19, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: metastatic; topotecan; Small cell lung cancer (SCLC); Delta-like protein 3 (DLL3); rovalpituzumab tesirine
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Disease Attributes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Disease Progression; 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; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Dexamethasone; Topotecan
• Other Study ID Numbers: M16-289; 2016-003726-17 (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)

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