ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03061812
Previous Study | Return to List | Next Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03061812
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : September 3, 2018
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 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 available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 411 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 : September 19, 2019
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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.

  2. Objective Response Rate (ORR) [ Time Frame: Approximately 34 months ]
    ORR is defined as the percentage of participants whose best overall response is complete response (CR) + partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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.


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 per Central Radiographic Assessment Committee (CRAC).
  • 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


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

  Hide Study Locations
Locations
United States, Alabama
Clearview Cancer Institute /ID# 155873 Recruiting
Huntsville, Alabama, United States, 35805
University of South Alabama /ID# 158151 Recruiting
Mobile, Alabama, United States, 36604
United States, Arkansas
Highlands Oncology Group /ID# 155902 Recruiting
Fayetteville, Arkansas, United States, 72703-4005
Carti /Id# 156982 Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Cedars-Sinai Medical Center /ID# 157102 Not yet recruiting
Beverly Hills, California, United States, 90211
Ucsd /Id# 156965 Recruiting
La Jolla, California, United States, 92037
Los Angeles Hematology Oncolog /ID# 155879 Not yet recruiting
Los Angeles, California, United States, 90017
UC Davis Comp Cancer Ctr /ID# 157001 Recruiting
Sacramento, California, United States, 95817
St Jude Hospital dba St Joseph /ID# 155899 Recruiting
Santa Rosa, California, United States, 95403
Icri /Id# 157090 Recruiting
Whittier, California, United States, 90603
United States, Delaware
Christiana Care Health Service /ID# 158171 Recruiting
Newark, Delaware, United States, 19713
United States, Florida
Cancer Specialists /ID# 155828 Not yet recruiting
Jacksonville, Florida, United States, 32256
United States, Georgia
Georgia Cancer Center /ID# 160206 Recruiting
Atlanta, Georgia, United States, 30060
United States, Idaho
St. Luke's Mt States Tumor /ID# 164550 Recruiting
Meridian, Idaho, United States, 83642
United States, Illinois
NorthShore Univ HealthSystem /ID# 157054 Recruiting
Evanston, Illinois, United States, 60201
Ingalls Memorial Hosp /ID# 155871 Not yet recruiting
Harvey, Illinois, United States, 60426
United States, Indiana
Goshen Center for Cancer Care /ID# 155946 Recruiting
Goshen, Indiana, United States, 46526
United States, Kentucky
University of Louisville /ID# 155947 Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Clinic Foundation /ID# 160807 Not yet recruiting
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Beth Israel Deaconess Med Ctr /ID# 203386 Not yet recruiting
Boston, Massachusetts, United States, 02215-5400
Dana-Farber Cancer Institute /ID# 160210 Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Edward W. Sparrow Hosp Assn /ID# 157021 Recruiting
Lansing, Michigan, United States, 48912
United States, Nebraska
Nebraska Hematology Oncology /ID# 155900 Recruiting
Lincoln, Nebraska, United States, 68506
United States, Ohio
Gabrail Cancer Center Research /ID# 155920 Not yet recruiting
Canton, Ohio, United States, 44718
United States, Oregon
Oregon Health and Science University /ID# 157055 Recruiting
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
UPMC Hillman Cancer Ctr /ID# 164403 Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Univ Medical Ctr Brackenridge /ID# 156967 Not yet recruiting
Austin, Texas, United States, 78701
UT Southwestern Medical Center /ID# 158150 Recruiting
Dallas, Texas, United States, 75390-7208
United States, Vermont
University of Vermont Medical Center /ID# 162317 Not yet recruiting
Burlington, Vermont, United States, 05401-1473
United States, Washington
University of Washington /ID# 162626 Recruiting
Seattle, Washington, United States, 98109
Medical Oncology Associates /ID# 156856 Recruiting
Spokane, Washington, United States, 99208
United States, West Virginia
West Virginia Univ School Med /ID# 155872 Recruiting
Morgantown, West Virginia, United States, 26506
Australia, New South Wales
Blacktown Hospital /ID# 158907 Recruiting
Blacktown, New South Wales, Australia, 2148
St George Hospital /ID# 158855 Recruiting
Kogarah, New South Wales, Australia, 2217
Southern Medical Day Care Ctr /ID# 158853 Recruiting
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
The Prince Charles Hospital /ID# 158897 Recruiting
Chermside, Queensland, Australia, 4032
Australia, Victoria
Ballarat Health Service /ID# 158904 Recruiting
Ballarat, Victoria, Australia, 3350
Austin Hospital /ID# 158898 Recruiting
Heidelberg, Victoria, Australia, 3084
Belarus
Bobruysk Interdistrict Onco. /ID# 169394 Not yet recruiting
Babruysk, Belarus, 213825
Belarus Cancer Center N.N. Alexandrov /ID# 159325 Recruiting
Lesnoy, Belarus, 223040
Mogilev Reg. Oncologic dispe /ID# 159326 Recruiting
Mogilev, Belarus, 212018
Belgium
CHU Saint-Pierre /ID# 159521 Not yet recruiting
Bruxelles, Bruxelles-Capitale, Belgium, 1000
Grand Hôpital de Charleroi /ID# 158748 Recruiting
Charleroi, Hainaut, Belgium, 6000
Cliniques universitaires Saint /ID# 158751 Recruiting
Brussels, Belgium, 1200
Hopital de Jolimont /ID# 159755 Recruiting
Haine Saint Paul, Belgium, 7100
UZ Leuven /ID# 158752 Recruiting
Leuven, Belgium, 3000
CHU de Liege Sart Tilman /ID# 158753 Recruiting
Liege, Belgium, 4000
CHU Charleroi (Vesale) /ID# 159756 Recruiting
Montigny-le-tilleul, Belgium, 6110
Brazil
Liga Norte Rio Grandense Cont. /ID# 159015 Not yet recruiting
Natal, Rio Grande Do Norte, Brazil, 59075-740
Associacao Hospital Beneficent /ID# 159668 Not yet recruiting
Passo Fundo, Rio Grande Do Norte, Brazil, 99010
Hospital Sao Lucas da PUCRS /ID# 159669 Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159666 Not yet recruiting
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
Inca /Id# 159665 Not yet recruiting
Rio de Janeiro, Brazil, 20231-050
Hospital de Cancer de Barretos /ID# 159017 Not yet recruiting
Sao Paulo, Brazil, 14784-400
Canada, Alberta
Cross Cancer Institute /ID# 159519 Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Juravinski Cancer Clinic /ID# 159514 Not yet recruiting
Hamilton, Ontario, Canada, L8V 1C3
Canada, Quebec
Hopital Sacre Coeur Montreal /ID# 159515 Recruiting
Montreal, Quebec, Canada, H4J 1C5
CHU de Quebec-Universite Laval /ID# 159093 Not yet recruiting
Quebec City, Quebec, Canada, G1R 2J6
China, Fujian
Fujian Provincial Cancer Hospital /ID# 204863 Not yet recruiting
Fuzhou, Fujian, China, 350014
China, Heilongjiang
Harbin Medical University Cancer Hospital /Id# 203123 Not yet recruiting
Haerbin, Heilongjiang, China, 150081
China, Henan
Henan Cancer Hospital /ID# 203984 Not yet recruiting
Zhengzhou, Henan, China, 450008
Henan Cancer Hospital /ID# 204638 Not yet recruiting
Zhengzhou, Henan, China, 450008
China, Hubei
Hubei Cancer Hospital /ID# 202887 Not yet recruiting
Wuhan, Hubei, China, 430079
China, Hunan
Hunan Cancer Hospital /ID# 202796 Not yet recruiting
Changsha, Hunan, China, 410006
China, Shanghai
Fudan University Shanghai Cancer Center /Id# 206016 Not yet recruiting
Shanghai, Shanghai, China, 200032
China, Xinjiang
Cancer Center of Xinjiang Medical University /ID# 203758 Not yet recruiting
Urumqi, Xinjiang, China, 830000
China, Yunnan
Yunnan Cancer Hospital /ID# 204912 Not yet recruiting
Kunming, Yunnan, China, 650118
China, Zhejiang
Zhejiang Cancer hospital /ID# 204500 Not yet recruiting
Hangzhou, Zhejiang, China, 310022
China
Beijing Cancer Hospital /ID# 202881 Not yet recruiting
Beijing, China, 100142
Fujian Medical Univ Union Hosp /ID# 204861 Not yet recruiting
Fuzhou, China, 350025
Jiangsu Province Hospital /ID# 205184 Not yet recruiting
Nanjing, China, 210029
4th Military Medical Universit /ID# 203985 Not yet recruiting
Xi'an, China, 710038
1st Aff Hos Xi'an Jiaotong Uni /ID# 203732 Not yet recruiting
Xi'an, China, 710061
1st Affiliated Hosp of Zhengzh /ID# 203030 Not yet recruiting
Zhengzhou, China, 450052
Croatia
Klinicki bolnicki centar Sestre milosrdnice /ID# 158811 Not yet recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinika za plucne bolesti Jordanovac /ID# 159502 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Rijeka /ID# 159501 Recruiting
Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
Czechia
Thomayerova nemocnice /ID# 159061 Recruiting
Prague, Praha 4, Czechia, 140 59
Nemocnice Na Plesi s.r.o. /ID# 161190 Not yet recruiting
Nová Ves pod Pleší, Pribram, Czechia, 262 04
Nemocnice Rudolfa a Stefanie /ID# 159652 Not yet recruiting
Benesov, Czechia, 256 01
Nemocnice Horovice a.s. /ID# 161191 Not yet recruiting
Horovice, Czechia, 268 31
Denmark
Herlev Hospital /ID# 158049 Recruiting
Herlev, Hovedstaden, Denmark, 2730
Odense Universitets Hospital /ID# 158050 Recruiting
Odense C, Syddanmark, Denmark, 5000
Rigshospitalet, Finsen Centre /ID# 158051 Recruiting
Copenhagen, Denmark, 2100
France
Hopital Haut-Lévêque /ID# 160558 Recruiting
Pessac CEDEX, Gironde, France, 33604
Assis.Publique-Hopital Nord /ID# 160554 Recruiting
Marseille, Provence-Alpes-Cote-d Azur, France, 13105
Centre Leon Berard /ID# 160561 Recruiting
Lyon CEDEX 08, Rhone, France, 69373
Centre Hosp Intercommunal /ID# 162684 Recruiting
Creteil, France, 94010
Assistance Publique- Hopitaux /ID# 160552 Recruiting
Paris, France, 75020
Hospital Pontchaillou /ID# 160555 Recruiting
Rennes, France, 35033
Germany
KH Martha-Maria Halle Dolau /ID# 158796 Recruiting
Halle (Saale), Sachsen-Anhalt, Germany, 06120
Evangelische Lungenklinik Berl /ID# 159168 Not yet recruiting
Berlin, Germany, 13125
Asklepios Fachkliniken M. Gaut /ID# 158791 Recruiting
Gauting, Germany, 82131
Lungen Clinic Grosshansdorf /ID# 158770 Recruiting
Grosshansdorf, Germany, 22927
Thoraxklinik Heidelberg gGmbH /ID# 159169 Not yet recruiting
Heidelberg, Germany, 69126
Klinikum Kassel /ID# 158788 Recruiting
Kassel, Germany, 34125
Klinik Loewenstein GmbH /ID# 159167 Recruiting
Löwenstein, Germany, 74245
Greece
Gen Hosp Chest Athens Sotiria /ID# 159165 Recruiting
Athens, Greece, 11527
Metropolitan Hospital /ID# 159162 Recruiting
Athens, Greece, 18547
University Hospital of Ioannin /ID# 159163 Recruiting
Ioannina, Greece, 45500
Euromedica General Clinic /ID# 159161 Recruiting
Thessaloniki, Greece, 54645
Hungary
Semmelweis Egyetem /ID# 161197 Recruiting
Budapest, Hungary, 1085
Orszagos Koranyi Pulmonologiai /ID# 158967 Recruiting
Budapest, Hungary, 1121
Debreceni Egyetem /ID# 161209 Recruiting
Debrecen, Hungary, 4032
Petz Aladar Megyei Oktato Korh /ID# 158978 Recruiting
Gyor, Hungary, 9023
Matrai Gyogyintezet /ID# 158979 Recruiting
Matrahaza, Hungary, 3233
Italy
AUSL 8 Arezzo Ospedale San Don /ID# 160967 Recruiting
Arezzo, Italy, 52100
Istituto Europeo di Oncologia /ID# 158942 Recruiting
Milan, Italy, 20141
AO Univ San Luigi Gonzaga /ID# 158945 Recruiting
Orbassano, Italy, 10043
Ospedale Santa Maria delle Cro /ID# 158940 Recruiting
Ravenna, Italy, 48121
IFO Istituto Nazionale Tumori /ID# 158941 Recruiting
Rome, Italy, 00144
Japan
Aichi Cancer Center Hospital /ID# 164975 Recruiting
Nagoya-shi, Aichi, Japan, 464-8681
National Cancer Ctr Hosp East /ID# 165726 Recruiting
Kashiwa-shi, Chiba, Japan, 277-8577
Kyushu University Hospital /ID# 165723 Recruiting
Fukuoka-shi, Fukuoka, Japan, 812-8582
Kurume University Hospital /ID# 164586 Not yet recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
Kanazawa University Hospital /ID# 165129 Not yet recruiting
Kanazawa, Ishikawa, Japan, 920-8641
Yokohama City University Hospital /ID# 165748 Recruiting
Yokohama-shi, Kanagawa, Japan, 2360004
Matsusaka City Hospital /ID# 166126 Recruiting
Matsusaka-shi, MIE, Japan, 515-8544
Japanese Red Cross Okayama Hospital /ID# 165156 Not yet recruiting
Okayama-shi, Okayama, Japan, 700-8607
Kansai Medical University Hospital /ID# 165055 Recruiting
Hirakata-shi, Osaka, Japan, 573-1191
Kinki University -Osakasayama Campus /ID# 166394 Recruiting
Osakasayama-shi, Osaka, Japan, 589-8511
Shizuoka cancer center /ID# 166466 Not yet recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
Tokushima University Hospital /ID# 165812 Recruiting
Tokushima-shi, Tokushima, Japan, 770-8503
National Cancer Center Hospital /ID# 166768 Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
The Cancer Institute Hosp JFCR /ID# 166249 Recruiting
Koto-ku, Tokyo, Japan, 135-8550
Showa University Hospital /ID# 165574 Recruiting
Shinagawa-ku, Tokyo, Japan
Hyogo Cancer Center /ID# 165125 Recruiting
Akashi, Japan, 673-8558
NHO Himeji Medical Center /ID# 165893 Recruiting
Himeji, Japan, 670-8520
Osaka City General Hospital /ID# 165717 Recruiting
Osaka, Japan, 534-0021
Hokkaido Cancer Center /ID# 165237 Recruiting
Sapporo, Japan, 003-0804
Sendai Kousei Hospital /ID# 166061 Recruiting
Sendai, Japan, 980-0873
Wakayama Medical University /ID# 166032 Recruiting
Wakayama, Japan, 641-8510
Kanagawa Cardio Resp Center /ID# 164374 Not yet recruiting
Yokohama, Japan, 236-0051
Kanagawa Cancer Center /ID# 165816 Recruiting
Yokohama, Japan, 241-0815
Korea, Republic of
Dong-A University Hospital /ID# 159296 Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
CHA Bundang Medical center, CHA University /ID# 204416 Not yet recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
Chonnam National University Hospital /ID# 159294 Not yet recruiting
Gwangju, Jeonranamdo, Korea, Republic of, 61469
Kyungpook National University Chilgok Hospital /ID# 159292 Not yet recruiting
Daegu, Seoul Teugbyeolsi, Korea, Republic of, 41404
Severance Hospital, Yonsei University Health System /ID# 159288 Recruiting
Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
Korea University Guro Hospital /ID# 159293 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
Chungbuk National University /ID# 159291 Recruiting
Cheongju-si, Korea, Republic of, 28644
Asan Medical Center /ID# 159290 Recruiting
Seoul, Korea, Republic of, 05505
Latvia
Pauls Stradins Clinical /ID# 158713 Recruiting
Riga, Latvia, LV-1002
Riga East Clinical University /ID# 158714 Recruiting
Riga, Latvia, LV-1079
Mexico
Instituto Nacional de Cancerol /ID# 171350 Not yet recruiting
Ciudad de México, Ciudad De Mexico, Mexico, 14080
Centro de Invest Clin Chapulte /ID# 161000 Not yet recruiting
Morelia, Michoacan, Mexico, 58260
Health Pharma Professional Res /ID# 160020 Not yet recruiting
Mexico, Mexico, 03810
Netherlands
Univ Med Center Groningen /ID# 158088 Recruiting
Groningen, Netherlands, 9713 GZ
St.Jansdal ziekenhuis /ID# 158652 Recruiting
Harderwijk, Netherlands, 3844 DG
Isala /ID# 158653 Not yet recruiting
Zwolle, Netherlands, 8025 AB
Poland
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 160537 Recruiting
Rzeszów, Podkarpackie, Poland, 35-021
Copernicus PL Sp. z o. o., WCO /ID# 160538 Not yet recruiting
Gdansk, Poland, 80-219
Szpitale Pomorskie Sp. z o.o /ID# 160536 Not yet recruiting
Gdynia, Poland, 81-519
Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 158687 Recruiting
Lisbon, Lisboa, Portugal, 1769-001
IPO Lisboa FG, EPE /ID# 158995 Recruiting
Lisboa, Portugal, 1099-023
Hospital da Luz, SA /ID# 158996 Not yet recruiting
Lisbon, Portugal, 1500-650
Unidade Local Saude Matosinhos /ID# 158682 Recruiting
Matosinhos, Portugal, 4464-513
Hospital CUF Porto /ID# 158685 Recruiting
Porto, Portugal, 4100-180
IPO Porto FG, EPE /ID# 158686 Not yet recruiting
Porto, Portugal, 4200-072
Romania
S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 160847 Not yet recruiting
Craiova, Dolj, Romania, 200347
Oncocenter Oncologie Clinica S /ID# 160848 Recruiting
Timisoara, Timis, Romania, 300166
Spitalul Judetean de Urgenta A /ID# 160846 Recruiting
Alba, Romania, 510077
Russian Federation
Arkhangelsk clinical oncology /ID# 159309 Recruiting
Arkhangelsk, Russian Federation, 163045
Kaluga Regional Clinical Oncol /ID# 160179 Recruiting
Kaluga, Russian Federation, 284007
Clinical Onco Dispensary /ID# 159307 Recruiting
Omsk, Russian Federation, 644013
PMI Euromedservice /ID# 159311 Recruiting
Pushkin, Russian Federation, 196603
LLC Novaya Klinika /ID# 205539 Not yet recruiting
Pyatigorsk, Russian Federation, 357532
Smolensk Regional Onc Clin Dis /ID# 159314 Not yet recruiting
Smolensk, Russian Federation, 214009
LLC BioEq Ltd. /ID# 159310 Recruiting
St. Petersburg, Russian Federation, 197342
N.N. Petrov Research Inst Onc /ID# 159312 Recruiting
St. Petersburg, Russian Federation, 197758
Serbia
Clinical Center of Nis /ID# 160059 Not yet recruiting
NIS, Nisavski Okrug, Serbia, 18000
Institut za onkologiju i radio /ID# 160058 Recruiting
Belgrade, Serbia, 11000
Klinicki centar Srbije /ID# 160024 Recruiting
Belgrade, Serbia, 11000
Institute For Pulmonary Diseas /ID# 158813 Recruiting
Sremska Kamenica, Serbia, 21204
Singapore
National University Hospital /ID# 158802 Recruiting
Singapore, Singapore, 119074
National Cancer Ctr Singapore /ID# 158803 Recruiting
Singapore, Singapore, 169610
Spain
Hosp. Sta Creu i Sant Pau /ID# 159028 Recruiting
Barcelona, Spain, 08025
Hospital Clinic de Barcelona /ID# 159031 Recruiting
Barcelona, Spain, 08036
Hosp. Gral. Univ. Gregorio Mar /ID# 159025 Recruiting
Madrid, Spain, 28009
Hosp Univ Madrid Sanchinarro /ID# 159024 Recruiting
Madrid, Spain, 28050
Hosp Clin Univ de Valencia /ID# 159027 Recruiting
Valencia, Spain, 46010
Sweden
Sahlgrenska US Gbg /ID# 159534 Not yet recruiting
Göteborg, Vastra Gotalands Lan, Sweden, 413 46
Uppsala University Hospital /ID# 159050 Recruiting
Uppsala, Sweden, 75185
Taiwan
National Cheng Kung University Hospital /ID# 158844 Recruiting
Tainan City, Tainan, Taiwan, 70403
National Taiwan University Hospital /ID# 158865 Recruiting
Taipei City, Taipei, Taiwan, 100
Tri-Service General Hospital /ID# 158985 Recruiting
Taipei City, Taipei, Taiwan, 11490
Taichung Veterans General Hosp /ID# 158866 Recruiting
Taichung City, Taiwan, 40705
Turkey
Hacettepe University Medical Faculty /ID# 159238 Recruiting
Altindağ, Ankara, Turkey, 06250
Ataturk Gogus Hastaliklari ve /ID# 160056 Recruiting
Keçiören, Ankara, Turkey, 06280
Inonu Universitesi Turgut Ozal /ID# 159241 Recruiting
Battalgazi, Turkey, 44280
Ege University Medical Faculty /ID# 159239 Recruiting
Izmir, Turkey, 35040
Dr. Suat Seren Gogus Has /ID# 159240 Recruiting
Izmir, Turkey, 35110
Ukraine
Municipal institution /ID# 159867 Not yet recruiting
Chernivtsi, Ukraine, 58013
Municipal institution Multifie /ID# 159121 Recruiting
Dnipro, Ukraine, 49102
Regional Center of Oncology /ID# 159123 Recruiting
Kharkiv, Ukraine, 61070
Medical and Diagnostic Center /ID# 159125 Recruiting
Kropyvnytskyi, Ukraine, 25006
Kryviy Rih Oncology Center /ID# 159119 Recruiting
Kryvyi Rih, Ukraine, 50048
Treatment and prevention /ID# 159124 Recruiting
Lutsk, Ukraine, 43018
Central Regional Clinical Hos. /ID# 159868 Recruiting
Uzhgorod, Ukraine
Communal Institution Zaporizhz /ID# 159122 Not yet recruiting
Zaporizhzhia, Ukraine, 69040
United Kingdom
Guy's and St Thomas' NHS Found /ID# 159581 Recruiting
London, London, City Of, United Kingdom, SE1 9RT
United Lincolnshire Hospitals /ID# 159579 Not yet recruiting
Boston, United Kingdom, PE21 9QS
Charing Cross Hospital /ID# 159582 Recruiting
London, United Kingdom, W6 8RF
Christie NHS Foundation Trust /ID# 159099 Recruiting
Manchester, United Kingdom, M20 4BX
James Cook University Hospital /ID# 159583 Recruiting
Middlesborough, United Kingdom, TS4 3BW
Royal Preston Hospital /ID# 159578 Recruiting
Preston, United Kingdom, PR2 9HT
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03061812     History of Changes
Other Study ID Numbers: M16-289
2016-003726-17 ( EudraCT Number )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
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

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AbbVie:
Small cell lung cancer (SCLC)
Delta-like protein 3 (DLL3)
rovalpituzumab tesirine
topotecan
metastatic

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents