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A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU) (MERU)

Primary Purpose

Small Cell Lung Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo for dexamethasone
Placebo for rovalpituzumab tesirine
Rovalpituzumab tesirine
Dexamethasone
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Extensive-Stage Small Cell Lung Cancer (ED SCLC), Cancer, Platinum-Based Chemotherapy, Rovalpituzumab tesirine, first-line chemotherapy, Small Cell Lung Cancer (SCLC), Delta-like protein 3 (DLL3)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC) at initial diagnosis with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR]) following completion of 4 cycles of first-line platinum-based therapy
  • Participant is eligible to be randomized at least 3 but no more than 9 weeks from Day 1 of the fourth cycle of first-line platinum-based chemotherapy.
  • Participants with a history of central nervous system (CNS) metastases prior to the initiation of first-line platinum-based chemotherapy must have received definitive local treatment and have documentation of stable or improved CNS disease status
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  • Participants must have adequate bone marrow, renal and hepatic function
  • Availability of archived or representative tumor material for assessment of DLL3 expression

Exclusion Criteria:

  • Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteria for SCLC.
  • Any disease-directed radiotherapy (except prophylactic cranial irradiation, palliative radiotherapy to a radiographically documented non-progressing lesion for symptom control, or pre-planned radiotherapy for CNS metastases present prior to start of first-line therapy and non-progressing) after last dose of first-line chemotherapy.
  • Prior exposure to a pyrrolobenzodiazepine (PBD-based) or indolinobenzodiazepine-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient contained in the drug formulation.

Sites / Locations

  • Clearview Cancer Institute /ID# 156699
  • University of South Alabama /ID# 160975
  • Highlands Oncology Group /ID# 156722
  • Marin Cancer Care /ID# 159207
  • Ucsd /Id# 157764
  • LA Hem-Oncology Med Group /ID# 156717
  • Palo Alto Veterans Institute for Research /ID# 203695
  • St Jude Hospital dba St Joseph /ID# 156526
  • Icri /Id# 157765
  • Kaiser Permanente Lone Tree /ID# 159331
  • Christiana Care Health Service /ID# 159212
  • Holy Cross Hospital /ID# 156716
  • University of Florida - Archer /ID# 155799
  • Memorial Cancer Institute /ID# 156673
  • Memorial Cancer Institute /ID# 164052
  • Cancer Specialists of North Florida - Southpoint /ID# 156595
  • Georgia Cancer Center /ID# 201894
  • Southeastern Regional Medical /ID# 163064
  • St. Luke's Mountain States Tumor Institute - Boise /ID# 156691
  • NorthShore University HealthSystem - Evanston Hospital /ID# 156664
  • Ingalls Memorial Hosp /ID# 156685
  • Goshen Center for Cancer Care /ID# 156682
  • Ashland-Bellefonte Cancer Ctr /ID# 202901
  • University of Louisville /ID# 156683
  • Ochsner Clinic Foundation /ID# 159136
  • Henry Ford Health System /ID# 156712
  • Sparrow Regional Cancer Center, Sparrow Health System /ID# 156590
  • Mayo Clinic - Rochester /ID# 160181
  • MidAmerica Division, Inc. /ID# 163530
  • Billings Clinic /ID# 201788
  • Nebraska Hematology Oncology /ID# 156534
  • MD Anderson Cancer Center at Cooper - Camden /ID# 156681
  • Montefiore Medical Center /ID# 201845
  • Northwell Health - Monter Cancer Center /ID# 159252
  • Icahn School of Med Mt. Sinai /ID# 159210
  • Stony Brook University Hospital /ID# 159272
  • Duke University Medical Center /ID# 156706
  • Cone Health /ID# 156689
  • Cone Health /ID# 163612
  • Eastern Carolina University /ID# 159264
  • Gabrail Cancer Center Research /ID# 156667
  • Kaiser Permanente, NW /ID# 201793
  • Thomas Jefferson University /ID# 156719
  • VA Pittsburgh HealthcareSystem /ID# 159284
  • Rhode Island Hospital /ID# 160834
  • Sarah Cannon Research Institute-Chattanooga /ID# 202933
  • Thompson Cancer Survival Ctr /ID# 202460
  • Tennessee Oncology-Nashville Centennial /ID# 161168
  • Univ Medical Ctr Brackenridge /ID# 155798
  • Parkland Health and Hosp Syste /ID# 170933
  • UT Southwestern Medical Center /ID# 157848
  • Houston Methodist Hospital - Scurlock Tower /ID# 202323
  • Medical Oncology Associates /ID# 156715
  • West Virginia Univ School Med /ID# 156687
  • Coffs Harbour Hospital /ID# 158880
  • Gosford Hospital /ID# 158884
  • Newcastle Private Hospital /ID# 203506
  • Royal North Shore Hospital /ID# 158881
  • Calvary North Adelaide Hospita /ID# 161701
  • Sunshine Hospital /ID# 161700
  • Affinity Clinical Research Ser /ID# 158887
  • SMZ Baumgartner Höhe, Otto-Wagner-Spital und Pflegezentrum /ID# 201776
  • Krankenhaus Nord - Klinik Floridsdorf /ID# 201768
  • LKH-Univ. Klinikum Graz /ID# 159563
  • Ordensklinikum Linz GmbH, Elisabethinen /ID# 159564
  • Salzburger Landeskliniken (SALK) /ID# 201779
  • Bobruysk Interdistrict Onco. /ID# 169393
  • State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159383
  • Mogilev Reg Clin Oncology Dis /ID# 159384
  • CHU Saint-Pierre /ID# 159009
  • Grand Hôpital de Charleroi /ID# 159006
  • ZNA Middelheim /ID# 159007
  • Hopital de Jolimont /ID# 159005
  • CHU Charleroi (Vesale) /ID# 159008
  • Hospital Evangelico de Cachoei /ID# 159657
  • Liga Norte Rio Grandense Cont. /ID# 159011
  • Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 159013
  • Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159661
  • Hospital Sao Lucas da PUCRS /ID# 159662
  • Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159012
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159659
  • Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159658
  • UMHAT Tsaritsa Joanna - ISUL /ID# 159638
  • UMHAT Sv. Ivan Rilski /ID# 159639
  • British Columbia Cancer Agency /ID# 163721
  • Brampton Civic Hospital /ID# 204425
  • R.S. McLaughlin Durham Regional /ID# 170870
  • Princess Margaret /ID# 170868
  • Windsor Regional Cancer Centre /ID# 170869
  • Iucpq-Ul /Id# 159530
  • Fujian Provincial Cancer Hospital /ID# 204864
  • Harbin Medical University Cancer Hospital /Id# 203638
  • Hubei Cancer Hospital /ID# 202886
  • Jilin Cancer Hosptial /ID# 204060
  • The Affiliated Cancer Hospital of Xinjiang Medical university /ID# 203641
  • Yunnan Cancer Hospital /ID# 204911
  • Zhejiang Cancer hospital /ID# 204640
  • Sir Run Run Shaw Hospital /ID# 206802
  • Jiangsu Province Hospital /ID# 205183
  • 4th Military Medical Universit /ID# 203986
  • First Affiliated Hospital of Xi'an Jiaotong University /ID# 203733
  • Henan Cancer Hospital /ID# 203983
  • Henan Cancer Hospital /ID# 204636
  • Klinicki bolnicki centar Sestre milosrdnice /ID# 159090
  • Klinika za plucne bolesti Jordanovac /ID# 159505
  • Klinicki bolnicki centar Rijeka /ID# 159504
  • Thomayerova nemocnice /ID# 159062
  • Nemocnice Rudolfa a Stefanie /ID# 159655
  • Nemocnice Horovice a.s. /ID# 161186
  • Vitkovicka nemocnice a. s. /ID# 161187
  • FN Plzen /ID# 204097
  • Oblastni Nemocnice Pribram /ID# 159654
  • Rigshospitalet /ID# 158055
  • Herlev Hospital /ID# 158053
  • Aalborg University Hospital /ID# 203737
  • Odense Universitets Hospital /ID# 158054
  • East Tallinn Central Hospital /ID# 160019
  • North Estonian Medical Centre /ID# 159779
  • Docrates Cancer Center /ID# 159591
  • CHU Hopital Nord /ID# 160543
  • Hopital Haut-Lévêque /ID# 160547
  • CHU Calmette /ID# 202706
  • Institut Curie /ID# 207514
  • Centre Leon Berard /ID# 160550
  • Centre Hosp Intercommunal de Creteil /ID# 162686
  • Hopital Tenon /ID# 160541
  • Hospital Pontchaillou /ID# 160544
  • Nouvel Hopital Civil (NHC) /ID# 204427
  • Hopital Larrey /ID# 204290
  • KH Martha-Maria Halle Dolau /ID# 158794
  • Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 158783
  • Evangelische Lungenklinik Berl /ID# 158935
  • Asklepios Fachkliniken M. Gaut /ID# 158789
  • Thoraxklinik Heidelberg gGmbH /ID# 158871
  • Lungenklinik Hemer /ID# 158790
  • Klinikum Kassel /ID# 158786
  • Klinik Loewenstein GmbH /ID# 158870
  • Fachkliniken Wangen /ID# 160779
  • Metropolitan General Hospital /ID# 202422
  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159160
  • Metropolitan Hospital /ID# 159157
  • University General Hospital of Heraklion PA.G.N.I /ID# 202409
  • University Hospital of Ioannin /ID# 159158
  • General Oncological Hospital /ID# 159159
  • Euromedica General Clinic /ID# 159156
  • Queen Elizabeth Hospital /ID# 159565
  • Princess Margaret Hospital /ID# 162810
  • Tuen Mun Hospital /ID# 162435
  • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 158962
  • Orszagos Koranyi Pulmonologiai Intezet /ID# 158953
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz - Pulmonologia /ID# 202466
  • Semmelweis Egyetem /ID# 158955
  • Csongrad Megyei Mellkasi Beteg /ID# 158952
  • St. James's Hospital /ID# 159712
  • Cork University Hospital /ID# 159715
  • St Vincent's University Hosp /ID# 161678
  • Beaumont Hospital /ID# 159711
  • University Hospital Limerick /ID# 159714
  • University Hospital Waterford /ID# 159713
  • Rabin Medical Center /ID# 159764
  • Tel Aviv Sourasky Medical Center /ID# 161467
  • Soroka University Medical Center /ID# 159762
  • Assaf Harofeh Medical Center /ID# 201883
  • Rambam Health Care Campus /ID# 202336
  • Hadassah /ID# 159763
  • Meir Medical Center /ID# 159761
  • Sheba Medical Center /ID# 159760
  • IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 160898
  • Policlinico Universitario Campus Bio-Medico /ID# 160874
  • AUSL 8 Arezzo Ospedale San Don /ID# 160897
  • A.O.U. San Luigi Gonzaga /ID# 158916
  • Ospedale Santa Maria delle Cro /ID# 158911
  • IFO Istituto Nazionale Tumori /ID# 158912
  • Aichi Cancer Center Hospital /ID# 164976
  • National Cancer Center Hospital East /ID# 165721
  • Kyushu University Hospital /ID# 165722
  • Kurume University Hospital /ID# 164595
  • Kanazawa University Hospital /ID# 165127
  • Kanagawa Cardiovascular and Respiratory Center /ID# 165015
  • Yokohama City University Hospital /ID# 165746
  • Japanese Red Cross Okayama Hospital /ID# 165157
  • Kansai Medical University Hospital /ID# 165054
  • Kindai University Hospital /ID# 166395
  • Shizuoka Cancer Center /ID# 166272
  • Tokushima University Hospital /ID# 166105
  • National Cancer Center Hospital /ID# 166547
  • Showa University Hospital /ID# 165575
  • Wakayama Medical University /ID# 165946
  • Hyogo Cancer Center /ID# 165138
  • National Hospital Organization Himeji Medical Center /ID# 165899
  • Matsusaka City Hospital /ID# 166156
  • Osaka City General Hospital /ID# 165714
  • Hokkaido Cancer Center /ID# 165236
  • Sendai Kousei Hospital /ID# 166491
  • Kanagawa Cancer Center /ID# 165814
  • Dong-A University Hospital /ID# 159305
  • CHA Bundang Medical center CHA University /ID# 161281
  • Kyungpook National University Chilgok Hospital /ID# 159301
  • Samsung Medical Center /ID# 159304
  • Korea University Guro Hospital /ID# 159302
  • Chungbuk National University /ID# 159300
  • Severance Hospital /ID# 159297
  • Asan Medical Center /ID# 159299
  • Pauls Stradins Clinical /ID# 158715
  • Riga East Clinical University /ID# 158716
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 160016
  • Klaipeda University Hospital /ID# 160018
  • National Cancer Institute /ID# 160017
  • Centro de Investigación Clinica Chapultepec /ID# 160965
  • Health Pharma professional Ser /ID# 160734
  • Meander Medisch Centrum /ID# 159064
  • Rijnstate /ID# 159063
  • Amphia Ziekenhuis /ID# 159065
  • Catharina Ziekenhuis /ID# 158082
  • Maastricht Universitair Medisch Centrum /ID# 161669
  • Jeroen Bosch Ziekenhuis /ID# 158081
  • Universitair Medisch Centrum Utrecht /ID# 158083
  • Akershus universitetssykehus /ID# 201682
  • Drammen Sykehus /ID# 159572
  • Haukeland University Hospital /ID# 159573
  • St. Olavs Hospital HF /ID# 163110
  • Radiumhospitalet, OUS /ID# 159574
  • Stavanger Universitetssykehus /ID# 159575
  • Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 159604
  • Wojewodzki Szpital Specjalisty /ID# 159603
  • Szpitale Pomorskie Sp. z o.o /ID# 159605
  • Centro Hospitalar Lisboa Norte, EPE /ID# 159957
  • IPO Lisboa FG, EPE /ID# 159949
  • Hospital da Luz, SA /ID# 159954
  • Unidade Local Saude Matosinhos /ID# 159950
  • Centro Hospitalar do Porto EPE /ID# 203582
  • Hospital CUF Porto /ID# 159955
  • IPO Porto FG, EPE /ID# 159956
  • National Medical Research Cntr /ID# 169885
  • Arkhangelsk clinical oncology /ID# 159367
  • Kaluga Regional Clinical Oncol /ID# 160180
  • Clinical Onco Dispensary /ID# 159365
  • PMI Euromedservice /ID# 159369
  • LLC Novaya Clinica /ID# 205523
  • OOO Centre of Palliative Medicine De Vita /ID# 206855
  • Ogarev Mordovia State Univ /ID# 205742
  • Smolensk Regional Onc Clin Dis /ID# 159372
  • LLC BioEq Ltd. /ID# 159368
  • N.N. Petrov Research Inst Onc /ID# 159370
  • Clinical Center Serbia /ID# 160902
  • Clin Hosp Ctr Bezanijska Kosa /ID# 160903
  • Clinical Center of Nis /ID# 160905
  • Institut za onkologiju i radio /ID# 160904
  • Institute For Pulmonary Diseas /ID# 164250
  • Cancercare Langenhoven Drive Oncology Centre /ID# 159126
  • Dr Albert, Bouwer and Jordaan Incorporated /ID# 158873
  • Mary Potter Oncology Centre /ID# 158877
  • The Oncology Centre /ID# 158872
  • Cape Town Oncology Trials /ID# 201311
  • Cancercare Outeniqua Oncology Unit /ID# 200689
  • Hospital Teresa Herrera - CHUAC /ID# 164368
  • Hospital Regional de Malaga /ID# 164371
  • Hospital Parc de Salut del Mar /ID# 159690
  • Hospital Universitario Vall d'Hebron /ID# 159708
  • Hospital Clinico Universitario San Carlos /ID# 159706
  • Hospital Universitario Fundacion Jimenez Diaz /ID# 159693
  • Hospital Universitario La Paz /ID# 159692
  • Hospital Clinico Universitario Lozano Blesa /ID# 159709
  • Centralsjukhuset, Karlstad /ID# 163451
  • Sahlgrenska US Gbg /ID# 159524
  • University Hospital Linkoping /ID# 159046
  • Karolinska Univ Sjukhuset /ID# 159649
  • Uppsala University Hospital /ID# 159052
  • Hopitaux Universitaires de Geneve /ID# 160603
  • Kantonsspital St. Gallen /ID# 160604
  • Universitaetsspital Basel /ID# 160605
  • Luzerner Kantonsspital /ID# 160607
  • Kantonsspital Winterthur /ID# 161379
  • China Medical University Hosp /ID# 158981
  • National Cheng Kung University Hospital /ID# 158799
  • National Taiwan Univ Hosp /ID# 159049
  • Tri-Service General Hospital /ID# 158980
  • Dalin Tzu Chi General Hospital /ID# 158983
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 158798
  • Taichung Veterans General Hosp /ID# 159047
  • Taipei Veterans General Hosp /ID# 203699
  • Hacettepe University Medical Faculty /ID# 159242
  • Erciyes University Medical Fac /ID# 202269
  • Ataturk Gogus Hastalikl /ID# 159556
  • Akdeniz Universitesi Tip Fakul /ID# 160791
  • Bezmi alem Vakif Universitesi /ID# 202267
  • Istanbul Medeniyet Universites /ID# 200126
  • Ege University Medical Faculty /ID# 159243
  • Dr. Suat Seren Gogus Has /ID# 159244
  • Inonu University /ID# 159245
  • CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159131
  • Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 159864
  • Municipal institution Multifie /ID# 159130
  • Regional Center of Oncology /ID# 159132
  • PE PMC Acinus, Medical and Diagnostic Center /ID# 165543
  • Volyn Regional Medical Oncology Centre /ID# 159133
  • Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159865
  • Cheltenham General Hospital /ID# 169096
  • Queen Elizabeth Medical Centre /ID# 162899
  • The Royal Bournemouth Hospital /ID# 159039
  • Colchester General Hospital /ID# 159042
  • Hereford County Hospital /ID# 159038
  • St. George's Healthcare NHS /ID# 202416
  • Charing Cross Hospital /ID# 161399
  • Maidstone Hospital /ID# 159043
  • Christie NHS Foundation Trust /ID# 159037
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 159044
  • Torbay Hospital - So Devon HC /ID# 159041

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rovalpituzumab tesirine/dexamethasone

Placebo

Arm Description

Rovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle

Placebo q6 wk; omitting every third cycle

Outcomes

Primary Outcome Measures

Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.

Secondary Outcome Measures

OS in All Randomized Participants
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.

Full Information

First Posted
January 25, 2017
Last Updated
July 28, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03033511
Brief Title
A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
Acronym
MERU
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Independent Data Monitoring Committee recommendation
Study Start Date
February 7, 2017 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
November 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Extensive-Stage Small Cell Lung Cancer (ED SCLC), Cancer, Platinum-Based Chemotherapy, Rovalpituzumab tesirine, first-line chemotherapy, Small Cell Lung Cancer (SCLC), Delta-like protein 3 (DLL3)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
748 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rovalpituzumab tesirine/dexamethasone
Arm Type
Experimental
Arm Description
Rovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo q6 wk; omitting every third cycle
Intervention Type
Drug
Intervention Name(s)
Placebo for dexamethasone
Intervention Description
Placebo for dexamethasone PO twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo for rovalpituzumab tesirine
Intervention Description
Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Intervention Type
Drug
Intervention Name(s)
Rovalpituzumab tesirine
Intervention Description
Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 8 mg administered orally (PO) twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
Primary Outcome Measure Information:
Title
Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)
Description
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
Time Frame
Survival follow-up continued until the endpoint of death, participant was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.
Secondary Outcome Measure Information:
Title
OS in All Randomized Participants
Description
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
Time Frame
Survival follow-up continued until the endpoint of death, the subject was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.
Title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Description
The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.
Time Frame
Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC) at initial diagnosis with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR]) following completion of 4 cycles of first-line platinum-based therapy Participant is eligible to be randomized at least 3 but no more than 9 weeks from Day 1 of the fourth cycle of first-line platinum-based chemotherapy. Participants with a history of central nervous system (CNS) metastases prior to the initiation of first-line platinum-based chemotherapy must have received definitive local treatment and have documentation of stable or improved CNS disease status Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 Participants must have adequate bone marrow, renal and hepatic function Availability of archived or representative tumor material for assessment of DLL3 expression Exclusion Criteria: Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteria for SCLC. Any disease-directed radiotherapy (except prophylactic cranial irradiation, palliative radiotherapy to a radiographically documented non-progressing lesion for symptom control, or pre-planned radiotherapy for CNS metastases present prior to start of first-line therapy and non-progressing) after last dose of first-line chemotherapy. Prior exposure to a pyrrolobenzodiazepine (PBD-based) or indolinobenzodiazepine-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient contained in the drug formulation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Clearview Cancer Institute /ID# 156699
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
University of South Alabama /ID# 160975
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604-3302
Country
United States
Facility Name
Highlands Oncology Group /ID# 156722
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703-4005
Country
United States
Facility Name
Marin Cancer Care /ID# 159207
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Ucsd /Id# 157764
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
LA Hem-Oncology Med Group /ID# 156717
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Palo Alto Veterans Institute for Research /ID# 203695
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1207
Country
United States
Facility Name
St Jude Hospital dba St Joseph /ID# 156526
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Icri /Id# 157765
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Kaiser Permanente Lone Tree /ID# 159331
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Christiana Care Health Service /ID# 159212
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Holy Cross Hospital /ID# 156716
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Florida - Archer /ID# 155799
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Memorial Cancer Institute /ID# 156673
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021-5421
Country
United States
Facility Name
Memorial Cancer Institute /ID# 164052
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021-5421
Country
United States
Facility Name
Cancer Specialists of North Florida - Southpoint /ID# 156595
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Georgia Cancer Center /ID# 201894
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Southeastern Regional Medical /ID# 163064
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
St. Luke's Mountain States Tumor Institute - Boise /ID# 156691
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
NorthShore University HealthSystem - Evanston Hospital /ID# 156664
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ingalls Memorial Hosp /ID# 156685
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Goshen Center for Cancer Care /ID# 156682
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Ashland-Bellefonte Cancer Ctr /ID# 202901
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
University of Louisville /ID# 156683
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Clinic Foundation /ID# 159136
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70836-6455
Country
United States
Facility Name
Henry Ford Health System /ID# 156712
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Sparrow Regional Cancer Center, Sparrow Health System /ID# 156590
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 160181
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
MidAmerica Division, Inc. /ID# 163530
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Billings Clinic /ID# 201788
City
Billings
State/Province
Montana
ZIP/Postal Code
59101-0733
Country
United States
Facility Name
Nebraska Hematology Oncology /ID# 156534
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
MD Anderson Cancer Center at Cooper - Camden /ID# 156681
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Montefiore Medical Center /ID# 201845
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Northwell Health - Monter Cancer Center /ID# 159252
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Icahn School of Med Mt. Sinai /ID# 159210
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Stony Brook University Hospital /ID# 159272
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8183
Country
United States
Facility Name
Duke University Medical Center /ID# 156706
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-3000
Country
United States
Facility Name
Cone Health /ID# 156689
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Cone Health /ID# 163612
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Eastern Carolina University /ID# 159264
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Gabrail Cancer Center Research /ID# 156667
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Kaiser Permanente, NW /ID# 201793
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Thomas Jefferson University /ID# 156719
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-4414
Country
United States
Facility Name
VA Pittsburgh HealthcareSystem /ID# 159284
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Rhode Island Hospital /ID# 160834
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Sarah Cannon Research Institute-Chattanooga /ID# 202933
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404-1108
Country
United States
Facility Name
Thompson Cancer Survival Ctr /ID# 202460
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Tennessee Oncology-Nashville Centennial /ID# 161168
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1632
Country
United States
Facility Name
Univ Medical Ctr Brackenridge /ID# 155798
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Parkland Health and Hosp Syste /ID# 170933
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
UT Southwestern Medical Center /ID# 157848
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Facility Name
Houston Methodist Hospital - Scurlock Tower /ID# 202323
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical Oncology Associates /ID# 156715
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
West Virginia Univ School Med /ID# 156687
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Coffs Harbour Hospital /ID# 158880
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Gosford Hospital /ID# 158884
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Newcastle Private Hospital /ID# 203506
City
Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Royal North Shore Hospital /ID# 158881
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Calvary North Adelaide Hospita /ID# 161701
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Sunshine Hospital /ID# 161700
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Affinity Clinical Research Ser /ID# 158887
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
SMZ Baumgartner Höhe, Otto-Wagner-Spital und Pflegezentrum /ID# 201776
City
Vienna
State/Province
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Krankenhaus Nord - Klinik Floridsdorf /ID# 201768
City
Vienna
State/Province
Wien
ZIP/Postal Code
1210
Country
Austria
Facility Name
LKH-Univ. Klinikum Graz /ID# 159563
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Ordensklinikum Linz GmbH, Elisabethinen /ID# 159564
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Salzburger Landeskliniken (SALK) /ID# 201779
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Bobruysk Interdistrict Onco. /ID# 169393
City
Bobruisk
ZIP/Postal Code
213825
Country
Belarus
Facility Name
State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159383
City
Lesnoy
ZIP/Postal Code
223040
Country
Belarus
Facility Name
Mogilev Reg Clin Oncology Dis /ID# 159384
City
Mogilev
ZIP/Postal Code
212018
Country
Belarus
Facility Name
CHU Saint-Pierre /ID# 159009
City
Bruxelles
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Grand Hôpital de Charleroi /ID# 159006
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
ZNA Middelheim /ID# 159007
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Hopital de Jolimont /ID# 159005
City
Haine Saint Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
CHU Charleroi (Vesale) /ID# 159008
City
Montigny-le-tilleul
ZIP/Postal Code
6110
Country
Belgium
Facility Name
Hospital Evangelico de Cachoei /ID# 159657
City
Cachoeiro de Itapemirim
State/Province
Espirito Santo
ZIP/Postal Code
29308-020
Country
Brazil
Facility Name
Liga Norte Rio Grandense Cont. /ID# 159011
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 159013
City
Ijuí
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159661
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS /ID# 159662
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159012
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159659
City
Sao Jose Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159658
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
UMHAT Tsaritsa Joanna - ISUL /ID# 159638
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
UMHAT Sv. Ivan Rilski /ID# 159639
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
British Columbia Cancer Agency /ID# 163721
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
Brampton Civic Hospital /ID# 204425
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
R.S. McLaughlin Durham Regional /ID# 170870
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Princess Margaret /ID# 170868
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Windsor Regional Cancer Centre /ID# 170869
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
Iucpq-Ul /Id# 159530
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Fujian Provincial Cancer Hospital /ID# 204864
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Harbin Medical University Cancer Hospital /Id# 203638
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Hubei Cancer Hospital /ID# 202886
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Jilin Cancer Hosptial /ID# 204060
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
The Affiliated Cancer Hospital of Xinjiang Medical university /ID# 203641
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Name
Yunnan Cancer Hospital /ID# 204911
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
Facility Name
Zhejiang Cancer hospital /ID# 204640
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Sir Run Run Shaw Hospital /ID# 206802
City
Jianggan Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310018
Country
China
Facility Name
Jiangsu Province Hospital /ID# 205183
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
4th Military Medical Universit /ID# 203986
City
Xi'an
ZIP/Postal Code
710038
Country
China
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University /ID# 203733
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
Henan Cancer Hospital /ID# 203983
City
Zhengzhou Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Henan Cancer Hospital /ID# 204636
City
Zhengzhou Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Klinicki bolnicki centar Sestre milosrdnice /ID# 159090
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinika za plucne bolesti Jordanovac /ID# 159505
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Rijeka /ID# 159504
City
Rijeka
State/Province
Primorsko-goranska Zupanija
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Thomayerova nemocnice /ID# 159062
City
Prague
State/Province
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Nemocnice Rudolfa a Stefanie /ID# 159655
City
Benesov
ZIP/Postal Code
256 01
Country
Czechia
Facility Name
Nemocnice Horovice a.s. /ID# 161186
City
Horovice
ZIP/Postal Code
268 31
Country
Czechia
Facility Name
Vitkovicka nemocnice a. s. /ID# 161187
City
Ostrava
ZIP/Postal Code
703 84
Country
Czechia
Facility Name
FN Plzen /ID# 204097
City
Plzen
ZIP/Postal Code
323 00
Country
Czechia
Facility Name
Oblastni Nemocnice Pribram /ID# 159654
City
Pribram
ZIP/Postal Code
262 04
Country
Czechia
Facility Name
Rigshospitalet /ID# 158055
City
Copenhagen Ø
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev Hospital /ID# 158053
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Aalborg University Hospital /ID# 203737
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Odense Universitets Hospital /ID# 158054
City
Odense C
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
East Tallinn Central Hospital /ID# 160019
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
North Estonian Medical Centre /ID# 159779
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Docrates Cancer Center /ID# 159591
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Facility Name
CHU Hopital Nord /ID# 160543
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13915
Country
France
Facility Name
Hopital Haut-Lévêque /ID# 160547
City
Pessac CEDEX
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Calmette /ID# 202706
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59000
Country
France
Facility Name
Institut Curie /ID# 207514
City
Paris CEDEX 05
State/Province
Ile-de-France
ZIP/Postal Code
75248
Country
France
Facility Name
Centre Leon Berard /ID# 160550
City
Lyon CEDEX 08
State/Province
Rhone
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Hosp Intercommunal de Creteil /ID# 162686
City
Creteil
State/Province
Val-de-Marne
ZIP/Postal Code
94000
Country
France
Facility Name
Hopital Tenon /ID# 160541
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Hospital Pontchaillou /ID# 160544
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Nouvel Hopital Civil (NHC) /ID# 204427
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hopital Larrey /ID# 204290
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
KH Martha-Maria Halle Dolau /ID# 158794
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 158783
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Evangelische Lungenklinik Berl /ID# 158935
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Asklepios Fachkliniken M. Gaut /ID# 158789
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Thoraxklinik Heidelberg gGmbH /ID# 158871
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Lungenklinik Hemer /ID# 158790
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Facility Name
Klinikum Kassel /ID# 158786
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Klinik Loewenstein GmbH /ID# 158870
City
Löwenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
Fachkliniken Wangen /ID# 160779
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Facility Name
Metropolitan General Hospital /ID# 202422
City
Cholargos
State/Province
Attiki
ZIP/Postal Code
15562
Country
Greece
Facility Name
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159160
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Metropolitan Hospital /ID# 159157
City
Athens
ZIP/Postal Code
18547
Country
Greece
Facility Name
University General Hospital of Heraklion PA.G.N.I /ID# 202409
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
University Hospital of Ioannin /ID# 159158
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
General Oncological Hospital /ID# 159159
City
Nea Kifisia
ZIP/Postal Code
14564
Country
Greece
Facility Name
Euromedica General Clinic /ID# 159156
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Queen Elizabeth Hospital /ID# 159565
City
Kowloon
ZIP/Postal Code
852
Country
Hong Kong
Facility Name
Princess Margaret Hospital /ID# 162810
City
Lai Chi Kok
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Tuen Mun Hospital /ID# 162435
City
Tuen Mun
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 158962
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Orszagos Koranyi Pulmonologiai Intezet /ID# 158953
City
Budapest XII
State/Province
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz - Pulmonologia /ID# 202466
City
Nyiregyhaza
State/Province
Szabolcs-Szatmar-Bereg
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Semmelweis Egyetem /ID# 158955
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Csongrad Megyei Mellkasi Beteg /ID# 158952
City
Deszk
ZIP/Postal Code
6772
Country
Hungary
Facility Name
St. James's Hospital /ID# 159712
City
Dublin 8
State/Province
Dublin
ZIP/Postal Code
D08 E9P6
Country
Ireland
Facility Name
Cork University Hospital /ID# 159715
City
Cork
ZIP/Postal Code
T12 E8YV
Country
Ireland
Facility Name
St Vincent's University Hosp /ID# 161678
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
Beaumont Hospital /ID# 159711
City
Dublin
ZIP/Postal Code
D09 XR63
Country
Ireland
Facility Name
University Hospital Limerick /ID# 159714
City
Limerick
ZIP/Postal Code
V94F858
Country
Ireland
Facility Name
University Hospital Waterford /ID# 159713
City
Waterford
ZIP/Postal Code
X91 ER8E
Country
Ireland
Facility Name
Rabin Medical Center /ID# 159764
City
Petakh Tikva
State/Province
Tel-Aviv
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 161467
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Soroka University Medical Center /ID# 159762
City
Be'er Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Assaf Harofeh Medical Center /ID# 201883
City
Be'er Ya'akov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 202336
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah /ID# 159763
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Medical Center /ID# 159761
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Sheba Medical Center /ID# 159760
City
Ramat Gan
ZIP/Postal Code
5239424
Country
Israel
Facility Name
IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 160898
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-Medico /ID# 160874
City
Rome
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
AUSL 8 Arezzo Ospedale San Don /ID# 160897
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
A.O.U. San Luigi Gonzaga /ID# 158916
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Ospedale Santa Maria delle Cro /ID# 158911
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
IFO Istituto Nazionale Tumori /ID# 158912
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Aichi Cancer Center Hospital /ID# 164976
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East /ID# 165721
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Kyushu University Hospital /ID# 165722
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Kurume University Hospital /ID# 164595
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Kanazawa University Hospital /ID# 165127
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center /ID# 165015
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Yokohama City University Hospital /ID# 165746
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2360004
Country
Japan
Facility Name
Japanese Red Cross Okayama Hospital /ID# 165157
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
7008607
Country
Japan
Facility Name
Kansai Medical University Hospital /ID# 165054
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Kindai University Hospital /ID# 166395
City
Osaka-sayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Shizuoka Cancer Center /ID# 166272
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tokushima University Hospital /ID# 166105
City
Tokushima-shi
State/Province
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
National Cancer Center Hospital /ID# 166547
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Showa University Hospital /ID# 165575
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Wakayama Medical University /ID# 165946
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Hyogo Cancer Center /ID# 165138
City
Akashi
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
National Hospital Organization Himeji Medical Center /ID# 165899
City
Himeji
ZIP/Postal Code
670-8520
Country
Japan
Facility Name
Matsusaka City Hospital /ID# 166156
City
Matsusaka-shi MIE
ZIP/Postal Code
515-8544
Country
Japan
Facility Name
Osaka City General Hospital /ID# 165714
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Hokkaido Cancer Center /ID# 165236
City
Sapporo
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Sendai Kousei Hospital /ID# 166491
City
Sendai
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Kanagawa Cancer Center /ID# 165814
City
Yokohama
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Dong-A University Hospital /ID# 159305
City
Busan
State/Province
Busan Gwang Yeogsi
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
CHA Bundang Medical center CHA University /ID# 161281
City
Seongnam si
State/Province
Gyeonggido
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital /ID# 159301
City
Daegu
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 159304
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital /ID# 159302
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Chungbuk National University /ID# 159300
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Severance Hospital /ID# 159297
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 159299
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Pauls Stradins Clinical /ID# 158715
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Riga East Clinical University /ID# 158716
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 160016
City
Kovno
State/Province
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Klaipeda University Hospital /ID# 160018
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
National Cancer Institute /ID# 160017
City
Vilnius
ZIP/Postal Code
08660
Country
Lithuania
Facility Name
Centro de Investigación Clinica Chapultepec /ID# 160965
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58260
Country
Mexico
Facility Name
Health Pharma professional Ser /ID# 160734
City
Ciudad de México
ZIP/Postal Code
03810
Country
Mexico
Facility Name
Meander Medisch Centrum /ID# 159064
City
Amersfoort
ZIP/Postal Code
3813 TZ
Country
Netherlands
Facility Name
Rijnstate /ID# 159063
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Amphia Ziekenhuis /ID# 159065
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Catharina Ziekenhuis /ID# 158082
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Maastricht Universitair Medisch Centrum /ID# 161669
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Jeroen Bosch Ziekenhuis /ID# 158081
City
S Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht /ID# 158083
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Akershus universitetssykehus /ID# 201682
City
Nordbyhagen
State/Province
Akershus
ZIP/Postal Code
1474
Country
Norway
Facility Name
Drammen Sykehus /ID# 159572
City
Drammen
State/Province
Buskerud
ZIP/Postal Code
3004
Country
Norway
Facility Name
Haukeland University Hospital /ID# 159573
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5021
Country
Norway
Facility Name
St. Olavs Hospital HF /ID# 163110
City
Trondheim
State/Province
Sor-Trondelag
ZIP/Postal Code
7006
Country
Norway
Facility Name
Radiumhospitalet, OUS /ID# 159574
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Facility Name
Stavanger Universitetssykehus /ID# 159575
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 159604
City
Rzeszów
State/Province
Podkarpackie
ZIP/Postal Code
35-021
Country
Poland
Facility Name
Wojewodzki Szpital Specjalisty /ID# 159603
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o /ID# 159605
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Centro Hospitalar Lisboa Norte, EPE /ID# 159957
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Facility Name
IPO Lisboa FG, EPE /ID# 159949
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Hospital da Luz, SA /ID# 159954
City
Lisbon
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Unidade Local Saude Matosinhos /ID# 159950
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Centro Hospitalar do Porto EPE /ID# 203582
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Hospital CUF Porto /ID# 159955
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Facility Name
IPO Porto FG, EPE /ID# 159956
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
National Medical Research Cntr /ID# 169885
City
Moscow
State/Province
Moskovskaya Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Arkhangelsk clinical oncology /ID# 159367
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Kaluga Regional Clinical Oncol /ID# 160180
City
Kaluga
ZIP/Postal Code
284007
Country
Russian Federation
Facility Name
Clinical Onco Dispensary /ID# 159365
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
PMI Euromedservice /ID# 159369
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
LLC Novaya Clinica /ID# 205523
City
Pyatigorsk
ZIP/Postal Code
357532
Country
Russian Federation
Facility Name
OOO Centre of Palliative Medicine De Vita /ID# 206855
City
Saint Petersburg
ZIP/Postal Code
197343
Country
Russian Federation
Facility Name
Ogarev Mordovia State Univ /ID# 205742
City
Saransk
ZIP/Postal Code
430005
Country
Russian Federation
Facility Name
Smolensk Regional Onc Clin Dis /ID# 159372
City
Smolensk
ZIP/Postal Code
214009
Country
Russian Federation
Facility Name
LLC BioEq Ltd. /ID# 159368
City
St. Petersburg
ZIP/Postal Code
197342
Country
Russian Federation
Facility Name
N.N. Petrov Research Inst Onc /ID# 159370
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Clinical Center Serbia /ID# 160902
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clin Hosp Ctr Bezanijska Kosa /ID# 160903
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center of Nis /ID# 160905
City
NIS
State/Province
Nisavski Okrug
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Institut za onkologiju i radio /ID# 160904
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute For Pulmonary Diseas /ID# 164250
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Cancercare Langenhoven Drive Oncology Centre /ID# 159126
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Dr Albert, Bouwer and Jordaan Incorporated /ID# 158873
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0044
Country
South Africa
Facility Name
Mary Potter Oncology Centre /ID# 158877
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
The Oncology Centre /ID# 158872
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Cape Town Oncology Trials /ID# 201311
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Cancercare Outeniqua Oncology Unit /ID# 200689
City
George
State/Province
Western Cape
ZIP/Postal Code
6530
Country
South Africa
Facility Name
Hospital Teresa Herrera - CHUAC /ID# 164368
City
A Coruña
State/Province
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Regional de Malaga /ID# 164371
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Parc de Salut del Mar /ID# 159690
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron /ID# 159708
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos /ID# 159706
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz /ID# 159693
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 159692
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa /ID# 159709
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Centralsjukhuset, Karlstad /ID# 163451
City
Karlstad
State/Province
Varmlands Lan
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Sahlgrenska US Gbg /ID# 159524
City
Göteborg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 46
Country
Sweden
Facility Name
University Hospital Linkoping /ID# 159046
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Karolinska Univ Sjukhuset /ID# 159649
City
Solna
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Uppsala University Hospital /ID# 159052
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Hopitaux Universitaires de Geneve /ID# 160603
City
Genève
State/Province
Geneve
ZIP/Postal Code
1205
Country
Switzerland
Facility Name
Kantonsspital St. Gallen /ID# 160604
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Universitaetsspital Basel /ID# 160605
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Luzerner Kantonsspital /ID# 160607
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Kantonsspital Winterthur /ID# 161379
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
China Medical University Hosp /ID# 158981
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital /ID# 158799
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
National Taiwan Univ Hosp /ID# 159049
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Tri-Service General Hospital /ID# 158980
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Dalin Tzu Chi General Hospital /ID# 158983
City
Dalin Township
ZIP/Postal Code
622
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 158798
City
Kaohsiung
ZIP/Postal Code
80708
Country
Taiwan
Facility Name
Taichung Veterans General Hosp /ID# 159047
City
Taichung City
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 203699
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Hacettepe University Medical Faculty /ID# 159242
City
Altindağ
State/Province
Ankara
ZIP/Postal Code
06250
Country
Turkey
Facility Name
Erciyes University Medical Fac /ID# 202269
City
Melikgazi
State/Province
Kayseri
ZIP/Postal Code
38030
Country
Turkey
Facility Name
Ataturk Gogus Hastalikl /ID# 159556
City
Ankara
ZIP/Postal Code
06280
Country
Turkey
Facility Name
Akdeniz Universitesi Tip Fakul /ID# 160791
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Bezmi alem Vakif Universitesi /ID# 202267
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul Medeniyet Universites /ID# 200126
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Ege University Medical Faculty /ID# 159243
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Dr. Suat Seren Gogus Has /ID# 159244
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
Facility Name
Inonu University /ID# 159245
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159131
City
Zaporizhzhia
State/Province
Zaporizka Oblast
ZIP/Postal Code
69040
Country
Ukraine
Facility Name
Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 159864
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
Municipal institution Multifie /ID# 159130
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Regional Center of Oncology /ID# 159132
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
PE PMC Acinus, Medical and Diagnostic Center /ID# 165543
City
Kropyvnytskyi
ZIP/Postal Code
25006
Country
Ukraine
Facility Name
Volyn Regional Medical Oncology Centre /ID# 159133
City
Lutsk
ZIP/Postal Code
43018
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159865
City
Uzhhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Cheltenham General Hospital /ID# 169096
City
Cheltenham
State/Province
Gloucestershire
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Queen Elizabeth Medical Centre /ID# 162899
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
The Royal Bournemouth Hospital /ID# 159039
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Colchester General Hospital /ID# 159042
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Hereford County Hospital /ID# 159038
City
Hereford
ZIP/Postal Code
HR1 2ER
Country
United Kingdom
Facility Name
St. George's Healthcare NHS /ID# 202416
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Charing Cross Hospital /ID# 161399
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Maidstone Hospital /ID# 159043
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Christie NHS Foundation Trust /ID# 159037
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 159044
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Torbay Hospital - So Devon HC /ID# 159041
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing 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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
29290251
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.
Results Reference
derived

Learn more about this trial

A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)

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