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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)

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ClinicalTrials.gov Identifier: NCT03061812
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : June 18, 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 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

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 : July 31, 2020

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. Objective response rate (ORR) [ Time Frame: Approximately 23 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. 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. 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.



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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 per the 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

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United States, Alabama
Clearview Cancer Institute Recruiting
Huntsville, Alabama, United States, 35805
University of South Alabama Recruiting
Mobile, Alabama, United States, 36604
United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703-4005
CARTI Recruiting
Little Rock, Arkansas, United States, 72205
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Cedars-Sinai Medical Center Not yet recruiting
Beverly Hills, California, United States, 90211
UCSD Recruiting
La Jolla, California, United States, 92037
Los Angeles Hematology Oncolog Not yet recruiting
Los Angeles, California, United States, 90017
UC Davis Comp Cancer Ctr Recruiting
Sacramento, California, United States, 95817
St Jude Hospital dba St Joseph Recruiting
Santa Rosa, California, United States, 95403
ICRI Recruiting
Whittier, California, United States, 90603
United States, Delaware
Christiana Care Health Service Recruiting
Newark, Delaware, United States, 19713
United States, Florida
Cancer Specialists Not yet recruiting
Jacksonville, Florida, United States, 32256
United States, Georgia
Georgia Cancer Center Recruiting
Atlanta, Georgia, United States, 30060
United States, Idaho
St. Luke's Mt States Tumor Recruiting
Meridian, Idaho, United States, 83642
United States, Illinois
NorthShore Univ HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Ingalls Memorial Hosp Not yet recruiting
Harvey, Illinois, United States, 60426
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Goshen Center for Cancer Care Recruiting
Goshen, Indiana, United States, 46526
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Clinic Foundation Not yet recruiting
New Orleans, Louisiana, United States, 70121
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Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
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Edward W. Sparrow Hosp Assn Recruiting
Lansing, Michigan, United States, 48912
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Nebraska Hematology Oncology Recruiting
Lincoln, Nebraska, United States, 68506
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Gabrail Cancer Center Research Not yet recruiting
Canton, Ohio, United States, 44718
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Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
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Hershey, Pennsylvania, United States, 17033
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Pittsburgh, Pennsylvania, United States, 15232
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Austin, Texas, United States, 78701
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Dallas, Texas, United States, 75390-7208
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Burlington, Vermont, United States, 05401-1473
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University of Washington Not yet recruiting
Seattle, Washington, United States, 98109
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Spokane, Washington, United States, 99208
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Morgantown, West Virginia, United States, 26506
Australia, New South Wales
Blacktown Hospital Recruiting
Blacktown, New South Wales, Australia, 2148
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Kogarah, New South Wales, Australia, 2217
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Wollongong, New South Wales, Australia, 2500
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The Prince Charles Hospital Recruiting
Chermside, Queensland, Australia, 4032
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Ballarat Health Service Recruiting
Ballarat, Victoria, Australia, 3350
Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Belarus
Bobruysk Interdistrict Onco. Not yet recruiting
Bobruisk, Belarus, 213825
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Lesnoy, Belarus, 223040
Mogilev Reg. Oncologic dispe Not yet recruiting
Mogilev, Belarus, 212018
Belgium
CHU Saint-Pierre Not yet recruiting
Bruxelles, Bruxelles-Capitale, Belgium, 1000
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Charleroi, Hainaut, Belgium, 6000
Cliniques universitaires Saint Not yet recruiting
Brussels, Belgium, 1200
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Haine Saint Paul, Belgium, 7100
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Leuven, Belgium, 3000
CHU de Liege Sart Tilman Recruiting
Liege, Belgium, 4000
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Montigny-le-tilleul, Belgium, 6110
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Liga Norte Rio Grandense Cont. Not yet recruiting
Natal, Rio Grande Do Norte, Brazil, 59075-740
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Passo Fundo, Rio Grande Do Norte, Brazil, 99010
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
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Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
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Rio de Janeiro, Brazil, 20231-050
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Sao Paulo, Brazil, 14784-400
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Sofia, Bulgaria, 1527
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Sofia, Bulgaria, 1612
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Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
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Juravinski Cancer Clinic Not yet recruiting
Hamilton, Ontario, Canada, L8V 1C3
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Hopital Sacre Coeur Montreal Recruiting
Montreal, Quebec, Canada, H4J 1C5
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Quebec City, Quebec, Canada, G1R 2J6
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Hubei Cancer Hospital Not yet recruiting
Wuhan, Hubei, China, 430079
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Cancer Center of Xinjiang Medical University Not yet recruiting
Urumqi, Xinjiang, China, 830000
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1st Aff Hos Xi'an Jiaotong Uni Not yet recruiting
Xi'an, China, 710061
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Klinicki bolnicki centar Sestre milosrdnice Not yet recruiting
Zagreb, Grad Zagreb, Croatia, 10000
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Zagreb, Grad Zagreb, Croatia, 10000
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Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
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Thomayerova nemocnice Recruiting
Prague, Praha 4, Czechia, 140 59
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Nová Ves pod Pleší, Pribram, Czechia, 262 04
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Benesov, Czechia, 256 01
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Horovice, Czechia, 268 31
Krajska nemocnice Liberec a.s. Not yet recruiting
Liberec, Czechia, 46063
Denmark
Herlev Hospital Recruiting
Herlev, Hovedstaden, Denmark, 2730
Odense Universitets Hospital Recruiting
Odense C, Syddanmark, Denmark, 5000
Rigshospitalet, Finsen Centre Recruiting
Copenhagen, Denmark, 2100
France
Hopital Haut-Lévêque Recruiting
Pessac CEDEX, Gironde, France, 33604
Assis.Publique-Hopital Nord Recruiting
Marseille, Provence-Alpes-Cote-d Azur, France, 13105
Centre Leon Berard Recruiting
Lyon CEDEX 08, Rhone, France, 69373
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Creteil, France, 94010
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Paris, France, 75020
Hospital Pontchaillou Recruiting
Rennes, France, 35033
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KH Martha-Maria Halle Dolau Recruiting
Halle (Saale), Sachsen-Anhalt, Germany, 06120
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Berlin, Germany, 13125
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Gauting, Germany, 82131
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Grosshansdorf, Germany, 22927
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Heidelberg, Germany, 69126
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Kassel, Germany, 34125
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Löwenstein, Germany, 74245
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Athens, Greece, 11527
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Athens, Greece, 18547
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Ioannina, Greece, 45500
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Thessaloniki, Greece, 54645
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Semmelweis Egyetem Not yet recruiting
Budapest, Hungary, 1085
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Budapest, Hungary, 1121
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Debrecen, Hungary, 4032
Veszprem Megyei Tuedoegyogyint Not yet recruiting
Farkasgyepu, Hungary, 8582
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Gyor, Hungary, 9023
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Matrahaza, Hungary, 3233
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AUSL 8 Arezzo Ospedale San Don Not yet recruiting
Arezzo, Italy, 52100
Istituto Europeo di Oncologia Recruiting
Milan, Italy, 20141
AO Univ San Luigi Gonzaga Recruiting
Orbassano, Italy, 10043
Ospedale Santa Maria delle Cro Recruiting
Ravenna, Italy, 48121
IFO Istituto Nazionale Tumori Recruiting
Rome, Italy, 00144
Japan
Aichi Cancer Center Hospital Recruiting
Nagoya-shi, Aichi, Japan, 464-8681
National Cancer Ctr Hosp East Not yet recruiting
Kashiwa-shi, Chiba, Japan, 277-8577
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Fukuoka-shi, Fukuoka, Japan, 812-8582
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Kurume-shi, Fukuoka, Japan, 830-0011
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Kanazawa, Ishikawa, Japan, 920-8641
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Yokohama-shi, Kanagawa, Japan, 2360004
Japanese Red Cross Okayama Hospital Not yet recruiting
Okayama-shi, Okayama, Japan, 700-8607
Kansai Medical University Hospital Recruiting
Hirakata-shi, Osaka, Japan, 573-1191
Kindai University Hospital Recruiting
Osakasayama-shi, Osaka, Japan, 589-8511
Shizuoka cancer center Not yet recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
Tokushima University Hospital Recruiting
Tokushima-shi, Tokushima, Japan, 770-8503
National Cancer Center Hosp Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
The Cancer Institute Hosp JFCR Recruiting
Koto-ku, Tokyo, Japan, 135-8550
Showa University Hospital Recruiting
Shinagawa-ku, Tokyo, Japan
Hyogo Cancer Center Recruiting
Akashi, Japan, 673-8558
NHO Himeji Medical Center Not yet recruiting
Himeji, Japan, 670-8520
Matsusaka City Hospital Recruiting
Matsusaka-shi, MIE, Japan, 515-8544
Osaka City General Hospital Not yet recruiting
Osaka, Japan, 534-0021
Hokkaido Cancer Center Recruiting
Sapporo, Japan, 003-0804
Sendai Kousei Hospital Recruiting
Sendai, Japan, 980-0873
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Wakayama, Japan, 641-8510
Kanagawa Cardio Resp Center Not yet recruiting
Yokohama, Japan, 236-0051
Kanagawa Cancer Center Recruiting
Yokohama, Japan, 241-0815
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Dong-A University Hospital Not yet recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
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Seongnam-si, Gyeonggido, Korea, Republic of, 13496
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Gwangju, Jeonranamdo, Korea, Republic of, 61469
Kyungpook National University Chilgok Hospital Not yet recruiting
Daegu, Seoul Teugbyeolsi, Korea, Republic of, 41404
Severance Hospital, Yonsei University Health System Recruiting
Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
Korea University Guro Hospital Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
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Cheongju-si, Korea, Republic of, 28644
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Pauls Stradins Clinical Recruiting
Riga, Latvia, LV-1002
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Riga, Latvia, LV-1079
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Instituto Nacional de Cancerol Not yet recruiting
Ciudad de México, Ciudad De Mexico, Mexico, 14080
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Morelia, Michoacan, Mexico, 58260
Health Pharma Professional Res Not yet recruiting
Mexico, Mexico, 03810
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Univ Med Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
St.Jansdal ziekenhuis Recruiting
Harderwijk, Netherlands, 3844 DG
Isala Not yet recruiting
Zwolle, Netherlands, 8025 AB
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Copernicus PL Sp. z o. o., WCO Not yet recruiting
Gdansk, Poland, 80-219
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Gdynia, Poland, 81-519
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Rzeszow, Poland, 35-922
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Centro Hospitalar Lisboa Norte, EPE Recruiting
Lisbon, Lisboa, Portugal, 1769-001
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Lisboa, Portugal, 1099-023
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Lisbon, Portugal, 1500-650
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Matosinhos, Portugal, 4464-513
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Porto, Portugal, 4100-180
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Porto, Portugal, 4200-072
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S.C. Centrul de Oncologie Sf. Nectarie S.R.L. Not yet recruiting
Craiova, Dolj, Romania, 200347
Oncocenter Oncologie Clinica S Recruiting
Timisoara, Timis, Romania, 300166
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Alba, Romania, 510077
Russian Federation
Arkhangelsk clinical oncology Recruiting
Arkhangelsk, Russian Federation, 163045
Kaluga Regional Clinical Oncol Recruiting
Kaluga, Russian Federation, 284007
Clinical Onco Dispensary Recruiting
Omsk, Russian Federation, 644013
PMI Euromedservice Recruiting
Pushkin, Russian Federation, 196603
Smolensk Regional Onc Clin Dis Not yet recruiting
Smolensk, Russian Federation, 214009
LLC BioEq Ltd. Recruiting
St. Petersburg, Russian Federation, 197342
N.N. Petrov Research Inst Onc Recruiting
St. Petersburg, Russian Federation, 197758
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Clinical Center of Nis Not yet recruiting
NIS, Nisavski Okrug, Serbia, 18000
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Belgrade, Serbia, 11000
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Belgrade, Serbia, 11000
Institute For Pulmonary Diseas Recruiting
Sremska Kamenica, Serbia, 21204
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National University Hospital Recruiting
Singapore, Singapore, 119074
National Cancer Ctr Singapore Recruiting
Singapore, Singapore, 169610
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Barcelona, Spain, 08025
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Hosp. Gral. Univ. Gregorio Mar Recruiting
Madrid, Spain, 28009
Hosp Univ Madrid Sanchinarro Not yet recruiting
Madrid, Spain, 28050
Hosp Clin Univ de Valencia Recruiting
Valencia, Spain, 46010
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Sahlgrenska US Gbg Not yet recruiting
Göteborg, Vastra Gotalands Lan, Sweden, 413 46
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Uppsala, Sweden, 75185
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan City, Tainan, Taiwan, 70403
National Taiwan University Hospital Recruiting
Taipei City, Taipei, Taiwan, 100
Tri-Service General Hospital Recruiting
Taipei City, Taipei, Taiwan, 11490
Taichung Veterans General Hosp Recruiting
Taichung City, Taiwan, 40705
Turkey
Hacettepe University Medical Faculty Recruiting
Altindağ, Ankara, Turkey, 06250
Inonu Universitesi Turgut Ozal Recruiting
Battalgazi/malatya, Turkey, 44280
Ege University Medical Faculty Recruiting
Izmir, Turkey, 35040
Dr. Suat Seren Gogus Has Recruiting
Izmir, Turkey, 35110
Ataturk Gogus Hastaliklari ve Recruiting
Kecioren/ankara, Turkey, 06280
Ukraine
Municipal institution Not yet recruiting
Chernivtsi, Ukraine, 58013
Municipal institution Multifie Recruiting
Dnipro, Ukraine, 49102
Regional Center of Oncology Recruiting
Kharkiv, Ukraine, 61070
Medical and Diagnostic Center Not yet recruiting
Kropyvnytskyi, Ukraine, 25006
Kryviy Rih Oncology Center Recruiting
Kryviy RIH, Ukraine, 50048
Treatment and prevention Not yet recruiting
Lutsk, Ukraine, 43018
Central Regional Clinical Hos. Recruiting
Uzhgorod, Ukraine
Communal Institution Zaporizhz Not yet recruiting
Zaporizhzhia, Ukraine, 69040
United Kingdom
Guy's and St Thomas' NHS Found Recruiting
London, London, City Of, United Kingdom, SE1 9RT
United Lincolnshire Hospitals Not yet recruiting
Boston, United Kingdom, PE21 9QS
Charing Cross Hospital Not yet recruiting
London, United Kingdom, W6 8RF
Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
James Cook University Hospital Recruiting
Middlesborough, United Kingdom, TS4 3BW
Royal Preston Hospital 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: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
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