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Trial record 1 of 7 for:    TAHOE | SCLC
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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)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03061812
Recruitment Status : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this randomized, open-label, 2-arm, Phase 3 study is to assess the assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic Small Cell Lung Cancer (SCLC) with high levels of delta-like protein 3 (DLL3) and who have first disease progression during or following front-line platinum-based chemotherapy.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Rovalpituzumab tesirine Drug: Topotecan Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for High DLL3 Expressing Small Cell Lung Cancer (SCLC) Subjects With First Relapse/Recurrence Following Front-Line Platinum-Based Chemotherapy (TAHOE)
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : February 12, 2020
Estimated Study Completion Date : February 12, 2020


Arm Intervention/treatment
Experimental: Rovalpituzumab tesirine
Rovalpituzumab tesirine intravenous administration on Day 1 of a 42-Day cycle for 2 cycles.
Drug: Rovalpituzumab tesirine
Administered on Day 1 via intravenous infusion in a 42-day cycle for 2 cycles.

Active Comparator: Topotecan
Topotecan intravenous on Days 1 through 5 of each 21-Day cycle.
Drug: Topotecan
Administered on Day 1-5 via intravenous infusion in a 21-day cycle.




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 34 months ]
    Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Approximately 34 months ]
    ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  2. Change from baseline of the Physical functioning scale score in QLQ-C15-PAL [ Time Frame: Approximately 34 months ]
    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC OLQ-C15-PAL) is a questionnaire developed to assess the quality of life of palliative cancer care. Higher scores reflect greater symptom burden.

  3. Progression Free Survival (PFS) [ Time Frame: Approximately 34 months ]
    PFS is based on independent review of radiographic assessment, defined as the time from randomization to documented disease progression or death from any cause, whichever occurs earlier.

  4. Duration of Objective Response (DOR) [ Time Frame: Approximately 34 months ]
    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.

  5. Clinical Benefit Rate (CBR) [ Time Frame: Approximately 34 months ]
    CBR is defined as percentage of participants whose best overall response is complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.



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
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT03061812


Locations
Hide Hide 199 study locations
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United States, Alabama
Clearview Cancer Institute /ID# 155873
Huntsville, Alabama, United States, 35805
Mitchell Cancer Institute /ID# 158151
Mobile, Alabama, United States, 36604
United States, Arkansas
Highlands Oncology Group /ID# 155902
Fayetteville, Arkansas, United States, 72703-4005
Carti /Id# 156982
Little Rock, Arkansas, United States, 72205
United States, California
Cedars-Sinai Medical Center /ID# 157102
Beverly Hills, California, United States, 90211
Ucsd /Id# 156965
La Jolla, California, United States, 92093
Los Angeles Hematology Oncolog /ID# 155879
Los Angeles, California, United States, 90017
UC Davis Comp Cancer Ctr /ID# 157001
Sacramento, California, United States, 95817
St Jude Hospital dba St Joseph /ID# 155899
Santa Rosa, California, United States, 95403
Icri /Id# 157090
Whittier, California, United States, 90603
United States, Delaware
Christiana Care Health Service /ID# 158171
Newark, Delaware, United States, 19713
United States, Florida
Cancer Specialists of North Florida - Southpoint /ID# 155828
Jacksonville, Florida, United States, 32256
United States, Georgia
Georgia Cancer Center /ID# 160206
Atlanta, Georgia, United States, 30342
United States, Idaho
St. Luke's Mt States Tumor /ID# 164550
Meridian, Idaho, United States, 83642
United States, Illinois
NorthShore University HealthSystem - Evanston /ID# 157054
Evanston, Illinois, United States, 60201
Ingalls Memorial Hosp /ID# 155871
Harvey, Illinois, United States, 60426
United States, Indiana
Goshen Center for Cancer Care /ID# 155946
Goshen, Indiana, United States, 46526
United States, Kentucky
University of Louisville /ID# 155947
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Clinic Foundation /ID# 160807
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Beth Israel Deaconess Med Ctr /ID# 203386
Boston, Massachusetts, United States, 02215-5400
Dana-Farber Cancer Institute /ID# 160210
Boston, Massachusetts, United States, 02215
United States, Michigan
Edward W. Sparrow Hosp Assn /ID# 157021
Lansing, Michigan, United States, 48912
United States, Nebraska
Nebraska Hematology Oncology /ID# 155900
Lincoln, Nebraska, United States, 68506
United States, Ohio
Gabrail Cancer Center Research /ID# 155920
Canton, Ohio, United States, 44718
United States, Oregon
Oregon Health and Science University /ID# 157055
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
UPMC Hillman Cancer Ctr /ID# 164403
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Univ Medical Ctr Brackenridge /ID# 156967
Austin, Texas, United States, 78701
UT Southwestern Medical Center /ID# 158150
Dallas, Texas, United States, 75390-7208
United States, Vermont
University of Vermont Medical Center /ID# 162317
Burlington, Vermont, United States, 05401-1473
United States, Washington
University of Washington /ID# 162626
Seattle, Washington, United States, 98109
Medical Oncology Associates /ID# 156856
Spokane, Washington, United States, 99208
United States, West Virginia
West Virginia Univ School Med /ID# 155872
Morgantown, West Virginia, United States, 26506
Australia, New South Wales
Blacktown Hospital /ID# 158907
Blacktown, New South Wales, Australia, 2148
St George Hospital /ID# 158855
Kogarah, New South Wales, Australia, 2217
Southern Medical Day Care Ctr /ID# 158853
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
The Prince Charles Hospital /ID# 158897
Chermside, Queensland, Australia, 4032
Australia, Victoria
Ballarat Health Service /ID# 158904
Ballarat, Victoria, Australia, 3350
Austin Hospital /ID# 158898
Heidelberg, Victoria, Australia, 3084
Belarus
Bobruysk Interdistrict Onco. /ID# 169394
Bobruisk, Belarus, 213825
Belarus Cancer Center N.N. Alexandrov /ID# 159325
Lesnoy, Belarus, 223040
Mogilev Reg. Oncologic dispe /ID# 159326
Mogilev, Belarus, 212018
Belgium
CHU Saint-Pierre /ID# 159521
Bruxelles, Bruxelles-Capitale, Belgium, 1000
Grand Hôpital de Charleroi /ID# 158748
Charleroi, Hainaut, Belgium, 6000
Cliniques universitaires Saint /ID# 158751
Brussels, Belgium, 1200
Hopital de Jolimont /ID# 159755
Haine Saint Paul, Belgium, 7100
UZ Leuven /ID# 158752
Leuven, Belgium, 3000
CHU de Liege Sart Tilman /ID# 158753
Liege, Belgium, 4000
CHU Charleroi (Vesale) /ID# 159756
Montigny-le-tilleul, Belgium, 6110
Brazil
Liga Norte Rio Grandense Cont. /ID# 159015
Natal, Rio Grande Do Norte, Brazil, 59075-740
Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159668
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
Hospital Sao Lucas da PUCRS /ID# 159669
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159017
Barretos, Sao Paulo, Brazil, 14784-400
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159666
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
Inca /Id# 159665
Rio de Janeiro, Brazil, 20231-050
Bulgaria
UMHAT Tsaritsa Joanna - ISUL /ID# 159641
Sofia, Bulgaria, 1527
UMHAT Sv. Ivan Rilski /ID# 159642
Sofia, Bulgaria, 1612
Canada, Alberta
Cross Cancer Institute /ID# 159519
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Juravinski Cancer Clinic /ID# 159514
Hamilton, Ontario, Canada, L8V 1C3
Canada, Quebec
Hopital Sacre Coeur Montreal /ID# 159515
Montreal, Quebec, Canada, H4J 1C5
CHU de Quebec-Universite Laval /ID# 159093
Quebec City, Quebec, Canada, G1R 2J6
Cisss Du Bas-Saint-Laurent Hopital Regional de Rimouski /Id# 208931
Rimouski, Quebec, Canada, G5L 5T1
China, Jilin
Jilin Cancer Hosptial /ID# 204059
Changchun, Jilin, China, 130012
China
4th Military Medical Universit /ID# 203985
Xi'an, China, 710038
Croatia
Klinicki bolnicki centar Sestre milosrdnice /ID# 158811
Zagreb, Grad Zagreb, Croatia, 10000
Klinika za plucne bolesti Jordanovac /ID# 159502
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Rijeka /ID# 159501
Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
Czechia
Thomayerova nemocnice /ID# 159061
Prague, Praha 4, Czechia, 140 59
Nemocnice Na Plesi s.r.o. /ID# 161190
Nová Ves pod Pleší, Pribram, Czechia, 262 04
Nemocnice Rudolfa a Stefanie /ID# 159652
Benesov, Czechia, 256 01
Nemocnice Horovice a.s. /ID# 161191
Horovice, Czechia, 268 31
Krajska nemocnice Liberec a.s. /ID# 159653
Liberec, Czechia, 46063
Denmark
Herlev Hospital /ID# 158049
Herlev, Hovedstaden, Denmark, 2730
Odense Universitets Hospital /ID# 158050
Odense C, Syddanmark, Denmark, 5000
Rigshospitalet, Finsen Centre /ID# 158051
Copenhagen, Denmark, 2100
France
Hopital Haut-Lévêque /ID# 160558
Pessac CEDEX, Gironde, France, 33604
Assis.Publique-Hopital Nord /ID# 160554
Marseille, Provence-Alpes-Cote-d Azur, France, 13105
Centre Leon Berard /ID# 160561
Lyon CEDEX 08, Rhone, France, 69373
Centre Hosp Intercommunal /ID# 162684
Creteil, France, 94010
Assistance Publique- Hopitaux /ID# 160552
Paris, France, 75020
Hospital Pontchaillou /ID# 160555
Rennes, France, 35033
Germany
KH Martha-Maria Halle Dolau /ID# 158796
Halle (Saale), Sachsen-Anhalt, Germany, 06120
Evangelische Lungenklinik Berl /ID# 159168
Berlin, Germany, 13125
Asklepios Fachkliniken M. Gaut /ID# 158791
Gauting, Germany, 82131
Lungen Clinic Grosshansdorf /ID# 158770
Grosshansdorf, Germany, 22927
Thoraxklinik Heidelberg gGmbH /ID# 159169
Heidelberg, Germany, 69126
Klinikum Kassel /ID# 158788
Kassel, Germany, 34125
Klinik Loewenstein GmbH /ID# 159167
Löwenstein, Germany, 74245
Greece
General Hospital of Chest Diseases of Athens "SOTIRIA" /ID# 159165
Athens, Greece, 11527
Metropolitan Hospital /ID# 159162
Athens, Greece, 18547
University Hospital of Ioannin /ID# 159163
Ioannina, Greece, 45500
Euromedica General Clinic /ID# 159161
Thessaloniki, Greece, 54645
Hungary
Torokbalinti Tudogyogyintezet /ID# 207053
Budapest, Pest, Hungary, 2045
Semmelweis Egyetem /ID# 161197
Budapest, Hungary, 1085
Orszagos Koranyi Pulmonologiai /ID# 158967
Budapest, Hungary, 1122
Debreceni Egyetem /ID# 161209
Debrecen, Hungary, 4032
Veszprem Megyei Tuedoegyogyint /ID# 162607
Farkasgyepu, Hungary, 8582
Petz Aladar Megyei Oktato Korh /ID# 158978
Gyor, Hungary, 9023
Matrai Gyogyintezet /ID# 158979
Matrahaza, Hungary, 3233
Italy
AUSL 8 Arezzo Ospedale San Don /ID# 160967
Arezzo, Italy, 52100
Istituto Europeo di Oncologia /ID# 158942
Milan, Italy, 20141
AO Univ San Luigi Gonzaga /ID# 158945
Orbassano, Italy, 10043
Ospedale Santa Maria delle Cro /ID# 158940
Ravenna, Italy, 48121
IFO Istituto Nazionale Tumori /ID# 158941
Rome, Italy, 00144
Japan
Aichi Cancer Center Hospital /ID# 164975
Nagoya-shi, Aichi, Japan, 464-8681
National Cancer Ctr Hosp East /ID# 165726
Kashiwa-shi, Chiba, Japan, 277-8577
Kyushu University Hospital /ID# 165723
Fukuoka-shi, Fukuoka, Japan, 812-8582
Kurume University Hospital /ID# 164586
Kurume-shi, Fukuoka, Japan, 830-0011
Kanazawa University Hospital /ID# 165129
Kanazawa, Ishikawa, Japan, 920-8641
Yokohama City University Hospital /ID# 165748
Yokohama-shi, Kanagawa, Japan, 2360004
Japanese Red Cross Okayama Hospital /ID# 165156
Okayama-shi, Okayama, Japan, 700-8607
Kansai Medical University Hospital /ID# 165055
Hirakata-shi, Osaka, Japan, 573-1191
Kinki University -Osakasayama Campus /ID# 166394
Osakasayama-shi, Osaka, Japan, 589-8511
Shizuoka cancer center /ID# 166466
Sunto-gun, Shizuoka, Japan, 411-8777
Tokushima University Hospital /ID# 165812
Tokushima-shi, Tokushima, Japan, 770-8503
National Cancer Center Hospital /ID# 166768
Chuo-ku, Tokyo, Japan, 104-0045
The Cancer Institute Hosp JFCR /ID# 166249
Koto-ku, Tokyo, Japan, 135-8550
Showa University Hospital /ID# 165574
Shinagawa-ku, Tokyo, Japan
Hyogo Cancer Center /ID# 165125
Akashi, Japan, 673-8558
National Hospital Organization Himeji Medical Center /ID# 165893
Himeji, Japan, 670-8520
Matsusaka City Hospital /ID# 166126
Matsusaka-shi, MIE, Japan, 515-8544
Osaka City General Hospital /ID# 165717
Osaka, Japan, 534-0021
Hokkaido Cancer Center /ID# 165237
Sapporo, Japan, 003-0804
Sendai Kousei Hospital /ID# 166061
Sendai, Japan, 980-0873
Wakayama Medical University /ID# 166032
Wakayama, Japan, 641-8510
Kanagawa Cardio Resp Center /ID# 164374
Yokohama, Japan, 236-0051
Kanagawa Cancer Center /ID# 165816
Yokohama, Japan, 241-0815
Korea, Republic of
Dong-A University Hospital /ID# 159296
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
CHA Bundang Medical center, CHA University /ID# 204416
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
Chonnam National University Hospital /ID# 159294
Gwangju, Jeonranamdo, Korea, Republic of, 61469
Kyungpook National University Chilgok Hospital /ID# 159292
Daegu, Seoul Teugbyeolsi, Korea, Republic of, 41404
Yonsei University Health System, Severance Hospital /ID# 159288
Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
Korea University Guro Hospital /ID# 159293
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
Chungbuk National University /ID# 159291
Cheongju-si, Korea, Republic of, 28644
Asan Medical Center /ID# 159290
Seoul, Korea, Republic of, 05505
Latvia
Pauls Stradins Clinical /ID# 158713
Riga, Latvia, LV-1002
Riga East Clinical University /ID# 158714
Riga, Latvia, LV-1079
Mexico
Instituto Nacional de Cancerol /ID# 171350
Ciudad de México, Ciudad De Mexico, Mexico, 14080
Centro de Invest Clin Chapulte /ID# 161000
Morelia, Michoacan, Mexico, 58260
Health Pharma Professional Res /ID# 160020
Mexico, Mexico, 03810
Netherlands
Universitair Medisch Centrum Groningen /ID# 158088
Groningen, Netherlands, 9713 GZ
Ziekenhuis St. Jansdal /ID# 158652
Harderwijk, Netherlands, 3844 DG
Isala /ID# 158653
Zwolle, Netherlands, 8025 AB
Poland
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 160537
Rzeszów, Podkarpackie, Poland, 35-021
Copernicus PL Sp. z o. o., WCO /ID# 160538
Gdansk, Poland, 80-219
Szpitale Pomorskie Sp. z o.o /ID# 160536
Gdynia, Poland, 81-519
Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 158687
Lisbon, Lisboa, Portugal, 1769-001
IPO Lisboa FG, EPE /ID# 158995
Lisboa, Portugal, 1099-023
Hospital da Luz, SA /ID# 158996
Lisbon, Portugal, 1500-650
Unidade Local Saude Matosinhos /ID# 158682
Matosinhos, Portugal, 4464-513
Hospital CUF Porto /ID# 158685
Porto, Portugal, 4100-180
IPO Porto FG, EPE /ID# 158686
Porto, Portugal, 4200-072
Romania
S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 160847
Craiova, Dolj, Romania, 200347
Oncocenter Oncologie Clinica S /ID# 160848
Timisoara, Timis, Romania, 300166
Spitalul Judetean de Urgenta A /ID# 160846
Alba, Romania, 510077
Russian Federation
National Medical Research Cntr /ID# 207436
Moscow, Moskovskaya Oblast, Russian Federation, 115478
LLC Novaya Klinika /ID# 205539
Pyatigorsk, Stavropol Skiy Kray, Russian Federation, 357500
Arkhangelsk clinical oncology /ID# 159309
Arkhangelsk, Russian Federation, 163045
Kaluga Regional Clinical Oncol /ID# 160179
Kaluga, Russian Federation, 284007
Clinical Onco Dispensary /ID# 159307
Omsk, Russian Federation, 644013
PMI Euromedservice /ID# 159311
Pushkin, Russian Federation, 196603
Smolensk Regional Onc Clin Dis /ID# 159314
Smolensk, Russian Federation, 214009
LLC BioEq Ltd. /ID# 159310
St. Petersburg, Russian Federation, 197342
N.N. Petrov Research Inst Onc /ID# 159312
St. Petersburg, Russian Federation, 197758
Serbia
Clinical Center of Nis /ID# 160059
NIS, Nisavski Okrug, Serbia, 18000
Institut za onkologiju i radio /ID# 160058
Belgrade, Serbia, 11000
Klinicki centar Srbije /ID# 160024
Belgrade, Serbia, 11000
Institute For Pulmonary Diseas /ID# 158813
Sremska Kamenica, Serbia, 21204
Singapore
National University Hospital /ID# 158802
Singapore, Singapore, 119074
National Cancer Ctr Singapore /ID# 158803
Singapore, Singapore, 169610
Spain
Hosp. Sta Creu i Sant Pau /ID# 159028
Barcelona, Spain, 08025
Hospital Clinic de Barcelona /ID# 159031
Barcelona, Spain, 08036
Hosp. Gral. Univ. Gregorio Mar /ID# 159025
Madrid, Spain, 28009
Hosp Univ Madrid Sanchinarro /ID# 159024
Madrid, Spain, 28050
Hosp Clin Univ de Valencia /ID# 159027
Valencia, Spain, 46010
Sweden
Sahlgrenska US Gbg /ID# 159534
Göteborg, Vastra Gotalands Lan, Sweden, 413 46
Uppsala University Hospital /ID# 159050
Uppsala, Sweden, 75185
Taiwan
National Cheng Kung University Hospital /ID# 158844
Tainan City, Tainan, Taiwan, 70403
National Taiwan University Hospital /ID# 158865
Taipei City, Taipei, Taiwan, 100
Tri-Service General Hospital /ID# 158985
Taipei City, Taipei, Taiwan, 11490
Taichung Veterans General Hosp /ID# 158866
Taichung City, Taiwan, 40705
Turkey
Hacettepe University Medical Faculty /ID# 159238
Altindağ, Ankara, Turkey, 06250
Inonu Universitesi Turgut Ozal /ID# 159241
Battalgazi/malatya, Turkey, 44280
Ege University Medical Faculty /ID# 159239
Izmir, Turkey, 35040
Dr. Suat Seren Gogus Has /ID# 159240
Izmir, Turkey, 35110
Ataturk Gogus Hastaliklari ve /ID# 160056
Kecioren/ankara, Turkey, 06280
Ukraine
Municipal institution /ID# 159867
Chernivtsi, Ukraine, 58013
Municipal institution Multifie /ID# 159121
Dnipro, Ukraine, 49102
Regional Center of Oncology /ID# 159123
Kharkiv, Ukraine, 61070
Medical and Diagnostic Center /ID# 159125
Kropyvnytskyi, Ukraine, 25006
Kryviy Rih Oncology Center /ID# 159119
Kryviy RIH, Ukraine, 50048
Treatment and prevention /ID# 159124
Lutsk, Ukraine, 43018
Central Regional Clinical Hos. /ID# 159868
Uzhgorod, Ukraine
Communal Institution Zaporizhz /ID# 159122
Zaporizhzhia, Ukraine, 69040
United Kingdom
Guy's and St Thomas' NHS Found /ID# 159581
London, London, City Of, United Kingdom, SE1 9RT
United Lincolnshire Hospitals /ID# 159579
Boston, United Kingdom, PE21 9QS
Charing Cross Hospital /ID# 159582
London, United Kingdom, W6 8RF
Christie NHS Foundation Trust /ID# 159099
Manchester, United Kingdom, M20 4BX
James Cook University Hospital /ID# 159583
Middlesborough, United Kingdom, TS4 3BW
Royal Preston Hospital /ID# 159578
Preston, United Kingdom, PR2 9HT
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03061812    
Other Study ID Numbers: M16-289
2016-003726-17 ( EudraCT Number )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: April 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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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:
Small cell lung cancer (SCLC)
Delta-like protein 3 (DLL3)
rovalpituzumab tesirine
topotecan
metastatic
Additional relevant MeSH terms:
Layout table for MeSH terms
Small Cell Lung Carcinoma
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topotecan
Immunoconjugates
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs