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)
2 other identifiers
interventional
444
31 countries
184
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 SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2017
Typical duration for phase_3
184 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
April 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2020
CompletedResults Posted
Study results publicly available
February 23, 2021
CompletedFebruary 23, 2021
February 1, 2021
2.8 years
February 20, 2017
January 29, 2021
February 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Progression Free Survival (PFS)
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
Baseline, Week 7
Objective Response Rate (ORR)
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)
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)
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.
Study Arms (2)
Rovalpituzumab tesirine
EXPERIMENTALRovalpituzumab 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.
Topotecan
ACTIVE COMPARATORTopotecan 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.
Interventions
Powder for solution for infusion in vials.
Powder or solution for infusion in vials. Topotecan is commercially available as both a powder and solution for infusion. Availability will vary by region.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (195)
Clearview Cancer Institute /ID# 155873
Huntsville, Alabama, 35805, United States
Mitchell Cancer Institute /ID# 158151
Mobile, Alabama, 36604, United States
Carti /Id# 156982
Little Rock, Arkansas, 72205, United States
Highlands Oncology Group /ID# 155902
Springdale, Arkansas, 72762, United States
Cedars-Sinai Medical Center /ID# 157102
Beverly Hills, California, 90211, United States
Moore UC San Diego Cancer Center /ID# 156965
La Jolla, California, 92093, United States
Los Angeles Hematology Oncolog /ID# 155879
Los Angeles, California, 90017, United States
University of California, Davis Comprehensive Cancer Center /ID# 157001
Sacramento, California, 95817, United States
St Jude Hospital dba St Joseph /ID# 155899
Santa Rosa, California, 95403, United States
Icri /Id# 157090
Whittier, California, 90603, United States
Christiana Care Health Service /ID# 158171
Newark, Delaware, 19713, United States
Cancer Specialists of North Florida - Southpoint /ID# 155828
Jacksonville, Florida, 32256, United States
Georgia Cancer Center /ID# 160206
Atlanta, Georgia, 30342, United States
St. Luke's Mountain States Tumor Institute - Meridian /ID# 164550
Meridian, Idaho, 83712, United States
NorthShore University HealthSystem - Evanston Hospital /ID# 157054
Evanston, Illinois, 60201, United States
Ingalls Memorial Hosp /ID# 155871
Harvey, Illinois, 60426, United States
Goshen Center for Cancer Care /ID# 155946
Goshen, Indiana, 46526, United States
University of Louisville /ID# 155947
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation /ID# 160807
Baton Rouge, Louisiana, 70836-6455, United States
Dana-Farber Cancer Institute /ID# 160210
Boston, Massachusetts, 02215, United States
Sparrow Regional Cancer Center, Sparrow Health System /ID# 157021
Lansing, Michigan, 48912, United States
Nebraska Hematology Oncology /ID# 155900
Lincoln, Nebraska, 68506, United States
Gabrail Cancer Center Research /ID# 155920
Canton, Ohio, 44718, United States
Oregon Health and Science University /ID# 157055
Portland, Oregon, 97239, United States
UPMC Hillman Cancer Ctr /ID# 164403
Pittsburgh, Pennsylvania, 15232, United States
Univ Medical Ctr Brackenridge /ID# 156967
Austin, Texas, 78701, United States
UT Southwestern Medical Center /ID# 158150
Dallas, Texas, 75390-7208, United States
University of Vermont Medical Center /ID# 162317
Burlington, Vermont, 05401-1473, United States
University of Washington /ID# 162626
Seattle, Washington, 98109, United States
Medical Oncology Associates /ID# 156856
Spokane, Washington, 99208, United States
West Virginia Univ School Med /ID# 155872
Morgantown, West Virginia, 26506, United States
Blacktown Hospital /ID# 158907
Blacktown, New South Wales, 2148, Australia
St George Hospital /ID# 158855
Kogarah, New South Wales, 2217, Australia
Southern Medical Day Care Ctr /ID# 158853
Wollongong, New South Wales, 2500, Australia
The Prince Charles Hospital /ID# 158897
Chermside, Queensland, 4032, Australia
Ballarat Health Service /ID# 158904
Ballarat, Victoria, 3350, Australia
Austin Hospital /ID# 158898
Heidelberg, Victoria, 3084, Australia
Bobruysk Interdistrict Onco. /ID# 169394
Babruysk, 213825, Belarus
State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159325
Lesnoy, 223040, Belarus
Mogilev Reg. Oncologic dispe /ID# 159326
Mogilev, 212018, Belarus
CHU Saint-Pierre /ID# 159521
Brussels, Brussels Capital, 1000, Belgium
Grand Hôpital de Charleroi /ID# 158748
Charleroi, Hainaut, 6000, Belgium
Cliniques universitaires Saint /ID# 158751
Brussels, 1200, Belgium
Hopital de Jolimont /ID# 159755
Haine-Saint-Paul, 7100, Belgium
UZ Leuven /ID# 158752
Leuven, 3000, Belgium
CHU de Liege Sart Tilman /ID# 158753
Liège, 4000, Belgium
CHU Charleroi (Vesale) /ID# 159756
Montigny-le-Tilleul, 6110, Belgium
Liga Norte Rio Grandense Cont. /ID# 159015
Natal, Rio Grande do Norte, 59075-740, Brazil
Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159668
Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159017
Barretos, São Paulo, 14784-400, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159666
São José do Rio Preto, São Paulo, 15090-000, Brazil
Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159665
Rio de Janeiro, 20231-050, Brazil
UMHAT Tsaritsa Joanna - ISUL /ID# 159641
Sofia, 1527, Bulgaria
UMHAT Sv. Ivan Rilski /ID# 159642
Sofia, 1612, Bulgaria
Cross Cancer Institute /ID# 159519
Edmonton, Alberta, T6G 1Z2, Canada
Juravinski Cancer Clinic /ID# 159514
Hamilton, Ontario, L8V 1C3, Canada
Hopital du Sacre Coeur Montreal /ID# 159515
Montreal, Quebec, H4J 1C5, Canada
CHU de Quebec-Universite Laval /ID# 159093
Québec, Quebec, G1R 2J6, Canada
Cisss Du Bas-Saint-Laurent Hopital Regional de Rimouski /Id# 208931
Rimouski, Quebec, G5L 5T1, Canada
Jilin Cancer Hosptial /ID# 204059
Changchun, Jilin, 130000, China
Klinicki bolnicki centar Sestre milosrdnice /ID# 158811
Zagreb, City of Zagreb, 10000, Croatia
Klinika za plucne bolesti Jordanovac /ID# 159502
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Rijeka /ID# 159501
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Thomayerova nemocnice /ID# 159061
Prague, Praha 4, 140 59, Czechia
Nemocnice Na Plesi s.r.o. /ID# 161190
Nová Ves pod Pleší, Pribram, 262 04, Czechia
Nemocnice Rudolfa a Stefanie /ID# 159652
Benešov, 256 01, Czechia
Nemocnice Horovice a.s. /ID# 161191
Hořovice, 268 31, Czechia
Krajska nemocnice Liberec a.s. /ID# 159653
Liberec, 602 00, Czechia
Herlev Hospital /ID# 158049
Herlev, Capital Region, 2730, Denmark
Odense Universitets Hospital /ID# 158050
Odense C, Region Syddanmark, 5000, Denmark
Rigshospitalet, Finsen Centre /ID# 158051
Copenhagen, 2100, Denmark
Hopital Haut-Lévêque /ID# 160558
Pessac, Gironde, 33604, France
Assis.Publique-Hopital Nord /ID# 160554
Marseille, Provence-Alpes-Côte d'Azur Region, 13105, France
Centre Leon Berard /ID# 160561
Lyon, Rhone, 69373, France
Centre Hosp Intercommunal de Creteil /ID# 162684
Créteil, Val-de-Marne, 94000, France
Assistance Publique- Hopitaux /ID# 160552
Paris, 75020, France
Hospital Pontchaillou /ID# 160555
Rennes, 35033, France
KH Martha-Maria Halle Dolau /ID# 158796
Halle, Saxony-Anhalt, 06120, Germany
Evangelische Lungenklinik Berl /ID# 159168
Berlin, 13125, Germany
Asklepios Fachkliniken M. Gaut /ID# 158791
Gauting, 82131, Germany
Lungen Clinic Grosshansdorf /ID# 158770
Großhansdorf, 22927, Germany
Thoraxklinik Heidelberg gGmbH /ID# 159169
Heidelberg, 69126, Germany
Klinikum Kassel /ID# 158788
Kassel, 34125, Germany
Klinik Loewenstein GmbH /ID# 159167
Löwenstein, 74245, Germany
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159165
Athens, 11527, Greece
Metropolitan Hospital /ID# 159162
Athens, 18547, Greece
University Hospital of Ioannin /ID# 159163
Ioannina, 45500, Greece
Euromedica General Clinic /ID# 159161
Thessaloniki, 54645, Greece
Torokbalinti Tudogyogyintezet /ID# 207053
Budapest, Pest County, 2045, Hungary
Semmelweis Egyetem /ID# 161197
Budapest, 1085, Hungary
Orszagos Koranyi Pulmonologiai Intezet /ID# 158967
Budapest, 1122, Hungary
Dup_Debreceni Egyetem Klinikai Központ /ID# 161209
Debrecen, 4032, Hungary
Veszprem Megyei Tuedoegyogyint /ID# 162607
Farkasgyepű, 8582, Hungary
Petz Aladar Megyei Oktato Korh /ID# 158978
Győr, 9023, Hungary
Matrai Gyogyintezet /ID# 158979
Mátraháza, 3233, Hungary
AUSL 8 Arezzo Ospedale San Don /ID# 160967
Arezzo, 52100, Italy
Istituto Europeo di Oncologia /ID# 158942
Milan, 20141, Italy
A.O.U. San Luigi Gonzaga /ID# 158945
Orbassano, 10043, Italy
Ospedale Santa Maria delle Cro /ID# 158940
Ravenna, 48121, Italy
IFO Istituto Nazionale Tumori /ID# 158941
Rome, 00144, Italy
Aichi Cancer Center Hospital /ID# 164975
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East /ID# 165726
Kashiwa-shi, Chiba, 277-8577, Japan
Kyushu University Hospital /ID# 165723
Fukuoka, Fukuoka, 812-8582, Japan
Kurume University Hospital /ID# 164586
Kurume-shi, Fukuoka, 830-0011, Japan
Hokkaido Cancer Center /ID# 165237
Sapporo, Hokkaido, 003-0804, Japan
Hyogo Cancer Center /ID# 165125
Akashi-shi, Hyōgo, 673-8558, Japan
Himeji Medical Center /ID# 165893
Himeji-shi, Hyōgo, 670-0012, Japan
Duplicate_Kanazawa University Hospital /ID# 165129
Kanazawa, Ishikawa-ken, 920-8641, Japan
Yokohama City University Hospital /ID# 165748
Yokohama, Kanagawa, 236-0004, Japan
Kanagawa Cardiovascular and Respiratory Center /ID# 164374
Yokohama, Kanagawa, 236-0051, Japan
Sendai Kousei Hospital /ID# 166061
Sendai, Miyagi, 980-0873, Japan
Japanese Red Cross Okayama Hospital /ID# 165156
Okayama, Okayama-ken, 700-8607, Japan
Kansai Medical University Hospital /ID# 165055
Hirakata-shi, Osaka, 573-1191, Japan
Osaka City General Hospital /ID# 165717
Osaka, Osaka, 534-0021, Japan
Kindai University Hospital /ID# 166394
Osaka-sayama-shi, Osaka, 589-8511, Japan
Shizuoka Cancer Center /ID# 166466
Sunto-gun, Shizuoka, 411-8777, Japan
Tokushima University Hospital /ID# 165812
Tokushima, Tokushima, 770-8503, Japan
National Cancer Center Hospital /ID# 166768
Chuo-ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital Of JFCR /ID# 166249
Koto-ku, Tokyo, 135-8550, Japan
Duplicate_Showa University Hospital /ID# 165574
Shinagawa-ku, Tokyo, 142-0054, Japan
Wakayama Medical University /ID# 166032
Wakayama, Wakayama, 641-8510, Japan
Matsusaka City Hospital /ID# 166126
Matsusaka-shi MIE, 515-8544, Japan
Kanagawa Cancer Center /ID# 165816
Yokohama, 241-0815, Japan
Pauls Stradins Clinical /ID# 158713
Riga, LV-1002, Latvia
Riga East Clinical University /ID# 158714
Riga, LV-1079, Latvia
Centro de Investigación Clinica Chapultepec /ID# 161000
Morelia, Michoacán, 58260, Mexico
Health Pharma Professional Research S.A de C.V /ID# 160020
Del. Benito Juárez, 03810, Mexico
Universitair Medisch Centrum Groningen /ID# 158088
Groningen, 9713 GZ, Netherlands
Ziekenhuis St. Jansdal /ID# 158652
Harderwijk, 3844 DG, Netherlands
Isala /ID# 158653
Zwolle, 8025 AB, Netherlands
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 160537
Rzeszów, Podkarpackie Voivodeship, 35-021, Poland
Copernicus PL Sp. z o. o., WCO /ID# 160538
Gdansk, 80-219, Poland
Szpitale Pomorskie Sp. z o.o /ID# 160536
Gdynia, 81-519, Poland
Centro Hospitalar Lisboa Norte, EPE /ID# 158687
Lisbon, Lisbon District, 1769-001, Portugal
IPO Lisboa FG, EPE /ID# 158995
Lisbon, 1099-023, Portugal
Hospital da Luz, SA /ID# 158996
Lisbon, 1500-650, Portugal
Unidade Local Saude Matosinhos /ID# 158682
Matosinhos Municipality, 4464-513, Portugal
Hospital CUF Porto /ID# 158685
Porto, 4100-180, Portugal
IPO Porto FG, EPE /ID# 158686
Porto, 4200-072, Portugal
S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 160847
Craiova, Dolj, 200347, Romania
Oncocenter Oncologie Clinica S /ID# 160848
Timișoara, Timiș County, 300166, Romania
Spitalul Judetean de Urgenta A /ID# 160846
Alba, 510077, Romania
National Medical Research Cntr /ID# 207436
Moscow, Moscow Oblast, 115478, Russia
LLC Novaya Klinika /ID# 205539
Pyatigorsk, Stavropol Kray, 357500, Russia
Arkhangelsk clinical oncology /ID# 159309
Arkhangelsk, 163045, Russia
Kaluga Regional Clinical Oncol /ID# 160179
Kaluga, 284007, Russia
Clinical Onco Dispensary /ID# 159307
Omsk, 644013, Russia
PMI Euromedservice /ID# 159311
Pushkin, 196603, Russia
LLC BioEq Ltd. /ID# 159310
Saint Petersburg, 197342, Russia
N.N. Petrov Research Inst Onc /ID# 159312
Saint Petersburg, 197758, Russia
Smolensk Regional Onc Clin Dis /ID# 159314
Smolensk, 214009, Russia
Clinical Center of Nis /ID# 160059
Niš, Nisavski Okrug, 18000, Serbia
Institut za onkologiju i radio /ID# 160058
Belgrade, 11000, Serbia
Klinicki centar Srbije /ID# 160024
Belgrade, 11000, Serbia
Institute For Pulmonary Diseas /ID# 158813
Kamenitz, 21204, Serbia
National University Hospital /ID# 158802
Singapore, 119074, Singapore
National Cancer Ctr Singapore /ID# 158803
Singapore, 169610, Singapore
Dong-A University Hospital /ID# 159296
Busan, Busan Gwang Yeogsi, 49201, South Korea
CHA Bundang Medical center CHA University /ID# 204416
Seongnam-si, Gyeonggido, 13496, South Korea
Chonnam National University Hospital /ID# 159294
Gwangju, Jeonranamdo, 61469, South Korea
Kyungpook National University Chilgok Hospital /ID# 159292
Daegu, Seoul Teugbyeolsi, 41404, South Korea
Yonsei University Health System, Severance Hospital /ID# 159288
Seodaemun-gu, Seoul Teugbyeolsi, 03722, South Korea
Korea University Guro Hospital /ID# 159293
Seoul, Seoul Teugbyeolsi, 08308, South Korea
Chungbuk National University /ID# 159291
Cheongju-si, 28644, South Korea
Asan Medical Center /ID# 159290
Seoul, 05505, South Korea
Hospital Clinic /ID# 159031
Barcelona, 08036, Spain
Hospital Santa Creu i Sant Pau /ID# 159028
Barcelona, 08041, Spain
Hospital General Universitario Gregorio Maranon /ID# 159025
Madrid, 28007, Spain
Hospital Universitario HM Sanchinarro /ID# 159024
Madrid, 28050, Spain
Hospital Clinico Universitario de Valencia /ID# 159027
Valencia, 46010, Spain
Sahlgrenska US Gbg /ID# 159534
Gothenburg, Västra Götaland County, 413 46, Sweden
Uppsala University Hospital /ID# 159050
Uppsala, 75185, Sweden
National Cheng Kung University Hospital /ID# 158844
Tainan, Tainan, 70403, Taiwan
National Taiwan University Hospital /ID# 158865
Taipei City, Taipei, 100, Taiwan
Tri-Service General Hospital /ID# 158985
Taipei City, Taipei, 11490, Taiwan
Taichung Veterans General Hosp /ID# 158866
Taichung, 40705, Taiwan
Hacettepe University Medical Faculty /ID# 159238
Altindağ, Ankara, 06250, Turkey (Türkiye)
Inonu Universitesi Turgut Ozal /ID# 159241
Battalgazi/malatya, 44280, Turkey (Türkiye)
Ege University Medical Faculty /ID# 159239
Izmir, 35040, Turkey (Türkiye)
Dr. Suat Seren Gogus Has /ID# 159240
Izmir, 35110, Turkey (Türkiye)
Ataturk Gogus Hastaliklari ve /ID# 160056
Kecioren/ankara, 06280, Turkey (Türkiye)
CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159122
Zaporizhzhia, Zaporizhzhia Oblast, 69040, Ukraine
Municipal institution /ID# 159867
Chernivtsi, 58013, Ukraine
Municipal institution Multifie /ID# 159121
Dnipro, 49102, Ukraine
Regional Center of Oncology /ID# 159123
Kharkiv, 61070, Ukraine
PE PMC Acinus, Medical and Diagnostic Center /ID# 159125
Kropyvnytskyi, 25006, Ukraine
ME Kryviy Rih Oncology Dispensary /ID# 159119
Kryviy RIH, 50048, Ukraine
Volyn Regional Medical Oncology Centre /ID# 159124
Lutsk, 43018, Ukraine
Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159868
Uzhhorod, 88000, Ukraine
Guy's and St Thomas' NHS Found /ID# 159581
London, London, City of, SE1 9RT, United Kingdom
United Lincolnshire Hospitals /ID# 159579
Boston, PE21 9QS, United Kingdom
Charing Cross Hospital /ID# 159582
London, W6 8RF, United Kingdom
Christie NHS Foundation Trust /ID# 159099
Manchester, M20 4BX, United Kingdom
James Cook University Hospital /ID# 159583
Middlesbrough, TS4 3BW, United Kingdom
Royal Preston Hospital /ID# 159578
Preston, PR2 9HT, United Kingdom
Related Publications (2)
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.
PMID: 31506387BACKGROUNDTanaka 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.
PMID: 29290251DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
February 20, 2017
First Posted
February 23, 2017
Study Start
April 11, 2017
Primary Completion
February 12, 2020
Study Completion
February 12, 2020
Last Updated
February 23, 2021
Results First Posted
February 23, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
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.