Clinical trial NCT03061812: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small Cell Lung Cancer
Keywords: Small cell lung cancer (SCLC)
Delta-like protein 3 (DLL3)
rovalpituzumab tesirine
topotecan
metastatic
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 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:
measure: Progression Free Survival (PFS)
timeFrame: 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.
measure: 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
timeFrame: Baseline, Week 7
measure: Objective Response Rate (ORR)
timeFrame: 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.
measure: Clinical Benefit Rate (CBR)
timeFrame: 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.
measure: Duration of Objective Response (DOR)
timeFrame: 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.
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Institute /ID# 155873
state: Alabama
city: Mobile
country: United States
facility: Mitchell Cancer Institute /ID# 158151
state: Alabama
city: Little Rock
country: United States
facility: Carti /Id# 156982
state: Arkansas
city: Springdale
country: United States
facility: Highlands Oncology Group /ID# 155902
state: Arkansas
city: Beverly Hills
country: United States
facility: Cedars-Sinai Medical Center /ID# 157102
state: California
city: La Jolla
country: United States
facility: Moore UC San Diego Cancer Center /ID# 156965
state: California
city: Los Angeles
country: United States
facility: Los Angeles Hematology Oncolog /ID# 155879
state: California
city: Sacramento
country: United States
facility: University of California, Davis Comprehensive Cancer Center /ID# 157001
state: California
city: Santa Rosa
country: United States
facility: St Jude Hospital dba St Joseph /ID# 155899
state: California
city: Whittier
country: United States
facility: Icri /Id# 157090
state: California
city: Newark
country: United States
facility: Christiana Care Health Service /ID# 158171
state: Delaware
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida - Southpoint /ID# 155828
state: Florida
city: Atlanta
country: United States
facility: Georgia Cancer Center /ID# 160206
state: Georgia
city: Meridian
country: United States
facility: St. Luke's Mountain States Tumor Institute - Meridian /ID# 164550
state: Idaho
city: Evanston
country: United States
facility: NorthShore University HealthSystem - Evanston Hospital /ID# 157054
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hosp /ID# 155871
state: Illinois
city: Goshen
country: United States
facility: Goshen Center for Cancer Care /ID# 155946
state: Indiana
city: Louisville
country: United States
facility: University of Louisville /ID# 155947
state: Kentucky
city: Baton Rouge
country: United States
facility: Ochsner Clinic Foundation /ID# 160807
state: Louisiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 160210
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Regional Cancer Center, Sparrow Health System /ID# 157021
state: Michigan
city: Lincoln
country: United States
facility: Nebraska Hematology Oncology /ID# 155900
state: Nebraska
city: Canton
country: United States
facility: Gabrail Cancer Center Research /ID# 155920
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University /ID# 157055
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Ctr /ID# 164403
state: Pennsylvania
city: Austin
country: United States
facility: Univ Medical Ctr Brackenridge /ID# 156967
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center /ID# 158150
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center /ID# 162317
state: Vermont
city: Seattle
country: United States
facility: University of Washington /ID# 162626
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates /ID# 156856
state: Washington
city: Morgantown
country: United States
facility: West Virginia Univ School Med /ID# 155872
state: West Virginia
city: Blacktown
country: Australia
facility: Blacktown Hospital /ID# 158907
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital /ID# 158855
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Ctr /ID# 158853
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital /ID# 158897
state: Queensland
city: Ballarat
country: Australia
facility: Ballarat Health Service /ID# 158904
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital /ID# 158898
state: Victoria
city: Bobruisk
country: Belarus
facility: Bobruysk Interdistrict Onco. /ID# 169394
city: Lesnoy
country: Belarus
facility: State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159325
city: Mogilev
country: Belarus
facility: Mogilev Reg. Oncologic dispe /ID# 159326
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre /ID# 159521
state: Bruxelles-Capitale
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi /ID# 158748
state: Hainaut
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint /ID# 158751
city: Haine Saint Paul
country: Belgium
facility: Hopital de Jolimont /ID# 159755
city: Leuven
country: Belgium
facility: UZ Leuven /ID# 158752
city: Liege
country: Belgium
facility: CHU de Liege Sart Tilman /ID# 158753
city: Montigny-le-tilleul
country: Belgium
facility: CHU Charleroi (Vesale) /ID# 159756
city: Natal
country: Brazil
facility: Liga Norte Rio Grandense Cont. /ID# 159015
state: Rio Grande Do Norte
city: Passo Fundo
country: Brazil
facility: Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159668
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159017
state: Sao Paulo
city: Sao Jose Do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159666
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159665
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Joanna - ISUL /ID# 159641
city: Sofia
country: Bulgaria
facility: UMHAT Sv. Ivan Rilski /ID# 159642
city: Edmonton
country: Canada
facility: Cross Cancer Institute /ID# 159519
state: Alberta
city: Hamilton
country: Canada
facility: Juravinski Cancer Clinic /ID# 159514
state: Ontario
city: Montreal
country: Canada
facility: Hopital du Sacre Coeur Montreal /ID# 159515
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Quebec-Universite Laval /ID# 159093
state: Quebec
city: Rimouski
country: Canada
facility: Cisss Du Bas-Saint-Laurent Hopital Regional de Rimouski /Id# 208931
state: Quebec
city: Changchun
country: China
facility: Jilin Cancer Hosptial /ID# 204059
state: Jilin
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 158811
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinika za plucne bolesti Jordanovac /ID# 159502
state: Grad Zagreb
city: Rijeka
country: Croatia
facility: Klinicki bolnicki centar Rijeka /ID# 159501
state: Primorsko-goranska Zupanija
city: Prague
country: Czechia
facility: Thomayerova nemocnice /ID# 159061
state: Praha 4
city: Nová Ves pod Pleší
country: Czechia
facility: Nemocnice Na Plesi s.r.o. /ID# 161190
state: Pribram
city: Benesov
country: Czechia
facility: Nemocnice Rudolfa a Stefanie /ID# 159652
city: Horovice
country: Czechia
facility: Nemocnice Horovice a.s. /ID# 161191
city: Liberec
country: Czechia
facility: Krajska nemocnice Liberec a.s. /ID# 159653
city: Herlev
country: Denmark
facility: Herlev Hospital /ID# 158049
state: Hovedstaden
city: Odense C
country: Denmark
facility: Odense Universitets Hospital /ID# 158050
state: Syddanmark
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Finsen Centre /ID# 158051
city: Pessac CEDEX
country: France
facility: Hopital Haut-Lévêque /ID# 160558
state: Gironde
city: Marseille
country: France
facility: Assis.Publique-Hopital Nord /ID# 160554
state: Provence-Alpes-Cote-d Azur
city: Lyon CEDEX 08
country: France
facility: Centre Leon Berard /ID# 160561
state: Rhone
city: Creteil
country: France
facility: Centre Hosp Intercommunal de Creteil /ID# 162684
state: Val-de-Marne
city: Paris
country: France
facility: Assistance Publique- Hopitaux /ID# 160552
city: Rennes
country: France
facility: Hospital Pontchaillou /ID# 160555
city: Halle (Saale)
country: Germany
facility: KH Martha-Maria Halle Dolau /ID# 158796
state: Sachsen-Anhalt
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berl /ID# 159168
city: Gauting
country: Germany
facility: Asklepios Fachkliniken M. Gaut /ID# 158791
city: Grosshansdorf
country: Germany
facility: Lungen Clinic Grosshansdorf /ID# 158770
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH /ID# 159169
city: Kassel
country: Germany
facility: Klinikum Kassel /ID# 158788
city: Löwenstein
country: Germany
facility: Klinik Loewenstein GmbH /ID# 159167
city: Athens
country: Greece
facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159165
city: Athens
country: Greece
facility: Metropolitan Hospital /ID# 159162
city: Ioannina
country: Greece
facility: University Hospital of Ioannin /ID# 159163
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic /ID# 159161
city: Budapest
country: Hungary
facility: Torokbalinti Tudogyogyintezet /ID# 207053
state: Pest
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 161197
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet /ID# 158967
city: Debrecen
country: Hungary
facility: Dup_Debreceni Egyetem Klinikai Központ /ID# 161209
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Tuedoegyogyint /ID# 162607
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korh /ID# 158978
city: Matrahaza
country: Hungary
facility: Matrai Gyogyintezet /ID# 158979
city: Arezzo
country: Italy
facility: AUSL 8 Arezzo Ospedale San Don /ID# 160967
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia /ID# 158942
city: Orbassano
country: Italy
facility: A.O.U. San Luigi Gonzaga /ID# 158945
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Cro /ID# 158940
city: Rome
country: Italy
facility: IFO Istituto Nazionale Tumori /ID# 158941
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital /ID# 164975
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 165726
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 165723
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 164586
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Hokkaido Cancer Center /ID# 165237
state: Hokkaido
city: Akashi-shi
country: Japan
facility: Hyogo Cancer Center /ID# 165125
state: Hyogo
city: Himeji-shi
country: Japan
facility: Himeji Medical Center /ID# 165893
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Duplicate_Kanazawa University Hospital /ID# 165129
state: Ishikawa
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital /ID# 165748
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center /ID# 164374
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Sendai Kousei Hospital /ID# 166061
state: Miyagi
city: Okayama-shi
country: Japan
facility: Japanese Red Cross Okayama Hospital /ID# 165156
state: Okayama
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 165055
state: Osaka
city: Osaka-sayama-shi
country: Japan
facility: Kindai University Hospital /ID# 166394
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital /ID# 165717
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center /ID# 166466
state: Shizuoka
city: Tokushima-shi
country: Japan
facility: Tokushima University Hospital /ID# 165812
state: Tokushima
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 166768
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR /ID# 166249
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Duplicate_Showa University Hospital /ID# 165574
state: Tokyo
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University /ID# 166032
state: Wakayama
city: Matsusaka-shi MIE
country: Japan
facility: Matsusaka City Hospital /ID# 166126
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center /ID# 165816
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital /ID# 159296
state: Busan Gwang Yeogsi
city: Seongnam si
country: Korea, Republic of
facility: CHA Bundang Medical center CHA University /ID# 204416
state: Gyeonggido
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital /ID# 159294
state: Jeonranamdo
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital /ID# 159292
state: Seoul Teugbyeolsi
city: Seodaemun-gu
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital /ID# 159288
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital /ID# 159293
state: Seoul Teugbyeolsi
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University /ID# 159291
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 159290
city: Riga
country: Latvia
facility: Pauls Stradins Clinical /ID# 158713
city: Riga
country: Latvia
facility: Riga East Clinical University /ID# 158714
city: Morelia
country: Mexico
facility: Centro de Investigación Clinica Chapultepec /ID# 161000
state: Michoacan
city: Del. Benito Juárez
country: Mexico
facility: Health Pharma Professional Research S.A de C.V /ID# 160020
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 158088
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St. Jansdal /ID# 158652
city: Zwolle
country: Netherlands
facility: Isala /ID# 158653
city: Rzeszów
country: Poland
facility: Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 160537
state: Podkarpackie
city: Gdansk
country: Poland
facility: Copernicus PL Sp. z o. o., WCO /ID# 160538
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o /ID# 160536
city: Lisbon
country: Portugal
facility: Centro Hospitalar Lisboa Norte, EPE /ID# 158687
state: Lisboa
city: Lisboa
country: Portugal
facility: IPO Lisboa FG, EPE /ID# 158995
city: Lisbon
country: Portugal
facility: Hospital da Luz, SA /ID# 158996
city: Matosinhos
country: Portugal
facility: Unidade Local Saude Matosinhos /ID# 158682
city: Porto
country: Portugal
facility: Hospital CUF Porto /ID# 158685
city: Porto
country: Portugal
facility: IPO Porto FG, EPE /ID# 158686
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 160847
state: Dolj
city: Timisoara
country: Romania
facility: Oncocenter Oncologie Clinica S /ID# 160848
state: Timis
city: Alba
country: Romania
facility: Spitalul Judetean de Urgenta A /ID# 160846
city: Moscow
country: Russian Federation
facility: National Medical Research Cntr /ID# 207436
state: Moskovskaya Oblast
city: Pyatigorsk
country: Russian Federation
facility: LLC Novaya Klinika /ID# 205539
state: Stavropol Skiy Kray
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk clinical oncology /ID# 159309
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Clinical Oncol /ID# 160179
city: Omsk
country: Russian Federation
facility: Clinical Onco Dispensary /ID# 159307
city: Pushkin
country: Russian Federation
facility: PMI Euromedservice /ID# 159311
city: Smolensk
country: Russian Federation
facility: Smolensk Regional Onc Clin Dis /ID# 159314
city: St. Petersburg
country: Russian Federation
facility: LLC BioEq Ltd. /ID# 159310
city: St. Petersburg
country: Russian Federation
facility: N.N. Petrov Research Inst Onc /ID# 159312
city: NIS
country: Serbia
facility: Clinical Center of Nis /ID# 160059
state: Nisavski Okrug
city: Belgrade
country: Serbia
facility: Institut za onkologiju i radio /ID# 160058
city: Belgrade
country: Serbia
facility: Klinicki centar Srbije /ID# 160024
city: Sremska Kamenica
country: Serbia
facility: Institute For Pulmonary Diseas /ID# 158813
city: Singapore
country: Singapore
facility: National University Hospital /ID# 158802
city: Singapore
country: Singapore
facility: National Cancer Ctr Singapore /ID# 158803
city: Barcelona
country: Spain
facility: Hospital Clinic /ID# 159031
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 159028
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 159025
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro /ID# 159024
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia /ID# 159027
city: Göteborg
country: Sweden
facility: Sahlgrenska US Gbg /ID# 159534
state: Vastra Gotalands Lan
city: Uppsala
country: Sweden
facility: Uppsala University Hospital /ID# 159050
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 158844
state: Tainan
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 158865
state: Taipei
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital /ID# 158985
state: Taipei
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hosp /ID# 158866
city: Altindağ
country: Turkey
facility: Hacettepe University Medical Faculty /ID# 159238
state: Ankara
city: Battalgazi/malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal /ID# 159241
city: Izmir
country: Turkey
facility: Ege University Medical Faculty /ID# 159239
city: Izmir
country: Turkey
facility: Dr. Suat Seren Gogus Has /ID# 159240
city: Kecioren/ankara
country: Turkey
facility: Ataturk Gogus Hastaliklari ve /ID# 160056
city: Zaporizhzhia
country: Ukraine
facility: CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159122
state: Zaporizka Oblast
city: Chernivtsi
country: Ukraine
facility: Municipal institution /ID# 159867
city: Dnipro
country: Ukraine
facility: Municipal institution Multifie /ID# 159121
city: Kharkiv
country: Ukraine
facility: Regional Center of Oncology /ID# 159123
city: Kropyvnytskyi
country: Ukraine
facility: PE PMC Acinus, Medical and Diagnostic Center /ID# 159125
city: Kryviy RIH
country: Ukraine
facility: ME Kryviy Rih Oncology Dispensary /ID# 159119
city: Lutsk
country: Ukraine
facility: Volyn Regional Medical Oncology Centre /ID# 159124
city: Uzhhorod
country: Ukraine
facility: Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159868
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Found /ID# 159581
state: London, City Of
city: Boston
country: United Kingdom
facility: United Lincolnshire Hospitals /ID# 159579
city: London
country: United Kingdom
facility: Charing Cross Hospital /ID# 159582
city: Manchester
country: United Kingdom
facility: Christie NHS Foundation Trust /ID# 159099
city: Middlesborough
country: United Kingdom
facility: James Cook University Hospital /ID# 159583
city: Preston
country: United Kingdom
facility: Royal Preston Hospital /ID# 159578
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Tanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22.