Clinical trial NCT03539536: Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
Official title: Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer (NSCLC)
Cancer
Telisotuzumab vedotin
ABBV-399
c-Met, c-Met overexpression
metastatic
MET gene amplification
LUMINOSITY
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-05-29
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3).


Eligibility criteria: Inclusion Criteria:

* Have locally advanced or metastatic non-small cell lung cancer (NSCLC).
* Have c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory. Participant must submit archival or fresh tumor material for assessment of c-Met levels during the prescreening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. If archival tissue is negative for c-Met overexpression, subject can submit fresh biopsy material for reassessment of c-Met expression.
* Histologically documented non-squamous epidermal growth factor receptor (EGFR) wild type NSCLC (site documented EGFR status). Of note, subjects with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met. As of Protocol Version 11, Stage 1 is complete and Stage 2 is enrolling participants with non-squamous EGFR wild type NSCLC only.
* Must have received no more than 2 lines of prior systemic therapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic setting.
* Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same tyrosine kinase (TK) count as 1 line of therapy for the purposes of this eligibility criterion.
* Progressed on systemic cytotoxic therapy (or are ineligible for systemic cytotoxic chemotherapy) and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible), and prior anticancer therapies targeting driver gene alterations (if applicable).
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
* Treatment with any therapies within the noted time intervals is excluded prior to the first dose of telisotuzumab vedotin as noted in the protocol.
* Metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided within the protocol.

Exclusion Criteria:

* Have received radiation therapy to the lungs \< 6 months prior to the first dose of telisotuzumab vedotin.
* Have received any live vaccine within 30 days of the first dose of investigational product.
* Has adenosquamous histology.
* Have a history of other malignancies except those noted within the protocol.
* Have a history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids.
* Have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD within 3 months of the planned first dose of the study drug (Except for Sites in Ireland). For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.
* For Sites in Ireland Only: Must not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD. For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.
* Have a clinically significant condition(s) as noted in the protocol.
* Have unresolved clinically significant adverse events of Grade \>= 2 from prior anticancer therapy, except for alopecia or anemia.
* Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
* For Sites in France and Czech Republic Only: Have the following:

  * Known human immunodeficiency virus (HIV) infection. Note: HIV testing is not required for eligibility for this protocol unless mandated by local regulatory authority or ethics committee/institutional review board.
  * Active hepatitis B virus (HBV) infection, defined by hepatitis B surface antigen (HBsAg) positivity or HBV DNA \>= 500 IU/mL. In participants with known HBV infection, the presence of active infection must be tested locally. If HBV status is unknown, it must be tested locally at screening.
  * Active hepatitis C virus (HCV) infection, defined by HCV ribonucleic acid (RNA) positivity. Participants cured of HCV infection may be included in the study. In participants with known HCV infection, the presence of active infection must be tested locally. If HCV status is unknown, it must be tested locally at screening.
  * Uncontrolled autoimmune disease.

Primary outcomes:
measure: Overall Response Rate (ORR) (Stage 1 and Stage 2)
timeFrame: Up to approximately 3 years
measure: Number of Participants with Adverse Events (Alternate dose cohort)
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Duration of Response (DoR) (Stage 1 and Stage 2)
timeFrame: Up to approximately 3 years
measure: Disease Control Rate (DCR) (Stage 1 and Stage 2)
timeFrame: Up to approximately 3 years
measure: Progression-Free Survival (PFS) (Stage 1 and Stage 2)
timeFrame: Up to approximately 3 years
measure: Overall Survival (OS) (Stage 1 and Stage 2)
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama /ID# 212939
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Arizona /ID# 218550
state: Arizona
city: Springdale
country: United States
facility: Highlands Oncology Group, PA /ID# 215600
state: Arkansas
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 203219
state: California
city: Orange
country: United States
facility: LA Hematology-Oncology Med Group /ID# 203338
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center Sacramen /ID# 203299
state: California
city: Whittier
country: United States
facility: Icri /Id# 227835
state: California
city: Aurora
country: United States
facility: Univ of Colorado Cancer Center /ID# 203212
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers /ID# 215789
state: Colorado
city: Brooksville
country: United States
facility: Advanced Cancer Treatment Center /ID# 239565
state: Florida
city: Celebration
country: United States
facility: AdventHealth Celebration /ID# 215649
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic /ID# 218488
state: Florida
city: Orlando
country: United States
facility: AdventHealth Cancer Institute - Orlando /ID# 239960
state: Florida
city: Honolulu
country: United States
facility: Straub Clinic and Hospital /ID# 217905
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 203239
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center /ID# 203216
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem /ID# 215583
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hosp /ID# 203228
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, LTD /ID# 203238
state: Illinois
city: Goshen
country: United States
facility: Goshen Center for Cancer Care /ID# 215584
state: Indiana
city: Kansas City
country: United States
facility: Univ Kansas Med Ctr /ID# 216804
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas /ID# 203235
state: Kansas
city: Lexington
country: United States
facility: Baptist Health /ID# 203283
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute - St Matthews /ID# 203284
state: Kentucky
city: Lewiston
country: United States
facility: Central Maine Medical Center /ID# 216583
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital /ID# 203215
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 208124
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 203248
state: Massachusetts
city: West Bloomfield
country: United States
facility: Henry Ford Hospital - West Bloomfield /ID# 203220
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 215603
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic /ID# 227691
state: Mississippi
city: Kansas City
country: United States
facility: St. Lukes Cancer Institute /ID# 227697
state: Missouri
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 203217
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center /ID# 203292
state: Montana
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center /ID# 203350
state: New Hampshire
city: East Brunswick
country: United States
facility: Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 228868
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System /ID# 203404
state: New Jersey
city: Pennington
country: United States
facility: Capital Health Medical Center /ID# 203403
state: New Jersey
city: Summit
country: United States
facility: Overlook Medical Center /ID# 211160
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico /ID# 208339
state: New Mexico
city: Canton
country: United States
facility: Gabrail Cancer Center Research /ID# 216056
state: Ohio
city: Cleveland
country: United States
facility: Univ Hosp Cleveland /ID# 215648
state: Ohio
city: Elyria
country: United States
facility: Mercy Cancer Center /ID# 231972
state: Ohio
city: Oklahoma City
country: United States
facility: Mercy Research Mercy Clinic Oklahoma Communities, Inc. / OKC /ID# 230154
state: Oklahoma
city: Portland
country: United States
facility: Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301
state: Oregon
city: Hershey
country: United States
facility: Penn State University and Milton S. Hershey Medical Center /ID# 221844
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital /ID# 215585
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Veterans Healthcare System /ID# 215602
state: Pennsylvania
city: Knoxville
country: United States
facility: Thompson Cancer Survival Ctr /ID# 228874
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center /ID# 203281
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Hospital - Scurlock Tower /ID# 213268
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center- Temple /ID# 216578
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists - Fairfax /ID# 203224
state: Virginia
city: Renton
country: United States
facility: Valley Medical Center /ID# 231459
state: Washington
city: Seattle
country: United States
facility: University of Washington /ID# 206056
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin /ID# 210062
state: Wisconsin
city: Darlinghurst
country: Australia
facility: The Kinghorn Cancer Centre /ID# 207666
state: New South Wales
city: Lambton Heights
country: Australia
facility: Newcastle Private Hospital /ID# 206600
state: New South Wales
city: Tweed Heads
country: Australia
facility: The Tweed Hospital /ID# 206601
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Misericordiae Limited /ID# 229639
state: Queensland
city: Subiaco
country: Australia
facility: St John Of God Subiaco Hospital /ID# 226943
state: Western Australia
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen /ID# 217430
state: Antwerpen
city: La Louvière
country: Belgium
facility: Hospital La Louviere Site Jolimont - Helora /ID# 230586
state: Hainaut
city: Sint-Niklaas
country: Belgium
facility: Vitaz /Id# 239966
state: Oost-Vlaanderen
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet /ID# 238614
city: Gent
country: Belgium
facility: AZ Maria Middelares /ID# 233474
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis /ID# 234047
city: Kortrijk
country: Belgium
facility: AZ Groeninge /ID# 217431
city: Liege
country: Belgium
facility: CHU de Liege /ID# 230589
city: Namur
country: Belgium
facility: CHU UCL Namur - Sainte Elisabeth /ID# 234048
city: Dobrich
country: Bulgaria
facility: MHAT Dobrich /ID# 230074
city: Pleven
country: Bulgaria
facility: UMHAT Dr Georgi Stranski EAD /ID# 232024
city: Sofia
country: Bulgaria
facility: Medical Center Nadezhda /ID# 230473
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 232010
city: Edmonton
country: Canada
facility: Cross Cancer Institute /ID# 204540
state: Alberta
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute /ID# 205579
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre /ID# 204423
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie /ID# 211356
state: Quebec
city: Hefei
country: China
facility: Anhui Provincial Hospital /ID# 212096
state: Anhui
city: Hefei
country: China
facility: Anhui Chest Hospital /ID# 239048
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital /ID# 239058
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital /ID# 210133
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital /ID# 210808
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University /ID# 232261
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Cancer Center /ID# 231560
state: Guangxi
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University /ID# 227262
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital /Id# 231573
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital /ID# 210961
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211119
state: Hubei
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou /ID# 210787
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital /ID# 210563
state: Jilin
city: Jinan
country: China
facility: Shandong Cancer Hospital /ID# 231577
state: Shandong
city: Shanghai
country: China
facility: Shanghai Chest Hospital /ID# 210930
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center /Id# 210084
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 210022
state: Sichuan
city: Urumqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 227244
state: Xinjiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 211154
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer hospital /ID# 210085
state: Zhejiang
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze /ID# 229797
city: Praha
country: Czechia
facility: Multiscan s.r.o. /ID# 241926
city: Marseille
country: France
facility: APHM - Hopital Nord /ID# 209854
state: Bouches-du-Rhone
city: Bordeaux
country: France
facility: Institut Bergonie /ID# 216207
state: Gironde
city: Lille
country: France
facility: CHU Lille - Hôpital Albert Calmette /ID# 205105
state: Hauts-de-France
city: Paris CEDEX 05
country: France
facility: Institut Curie /ID# 207046
state: Paris
city: Bron
country: France
facility: HCL - Hopital Louis Pradel /ID# 216209
state: Rhone
city: Lyon CEDEX 08
country: France
facility: Centre Leon Berard /ID# 205107
state: Rhone
city: Creteil
country: France
facility: Centre Hosp Intercommunal de Creteil /ID# 227108
state: Val-de-Marne
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy /ID# 205149
state: Val-de-Marne
city: Strasbourg cedex
country: France
facility: CHU Strasbourg - Hopital Civil /ID# 208080
city: Toulon
country: France
facility: CHI Toulon-La Seyne sur Mer /ID# 230545
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim /ID# 228798
state: Baden-Wuerttemberg
city: Augsburg
country: Germany
facility: Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 232052
state: Bayern
city: Gießen
country: Germany
facility: Universitaetsklinikum Giessen /ID# 231856
state: Hessen
city: Halle (Saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle-Doelau /ID# 205442
state: Sachsen-Anhalt
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukolln /ID# 205928
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Muenchen-Gauting /ID# 207789
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm /ID# 208043
city: Kassel
country: Germany
facility: Klinikum Kassel /ID# 205443
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg /ID# 211615
city: Athens
country: Greece
facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 205528
state: Attiki
city: Piraeus
country: Greece
facility: Metropolitan Hospital /ID# 205529
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion PA.G.N.I /ID# 205530
state: Kriti
city: Thessaloniki
country: Greece
facility: Bioclinic Thessaloniki /ID# 227261
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic /ID# 227264
city: Encs
country: Hungary
facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 204878
state: Borsod-Abauj-Zemplen
city: Torokbalint
country: Hungary
facility: Torokbalinti Tudogyogyintezet /ID# 204883
state: Pest
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 204434
city: Farkasgyepu
country: Hungary
facility: Duplicate_Veszprem Megyei Tudogyogyintez /ID# 213950
city: Matrahaza
country: Hungary
facility: Matrai Gyogyintezet /ID# 204432
city: Wilton
country: Ireland
facility: Cork University Hospital /ID# 205103
state: Cork
city: Dublin 7
country: Ireland
facility: Mater Misericordiae Univ Hospital /ID# 231466
state: Dublin
city: Dublin 8
country: Ireland
facility: St James Hospital /ID# 205104
state: Dublin
city: Elm Park
country: Ireland
facility: St Vincent's University Hospital /ID# 205102
state: Dublin
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 204866
state: H_efa
city: Haifa
country: Israel
facility: Rabin Medical Center /ID# 215322
state: H_efa
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center /ID# 204898
state: HaDarom
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 204255
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 204254
state: Tel-Aviv
city: Milan
country: Italy
facility: Ospedale San Raffaele IRCCS /ID# 226973
state: Milano
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 215918
state: Roma
city: Rome
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini /ID# 205163
state: Roma
city: Orbassano
country: Italy
facility: A.O.U. San Luigi Gonzaga /ID# 204706
state: Torino
city: Avellino
country: Italy
facility: L'Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Mos /ID# 204707
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 216153
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 205601
city: Napoli
country: Italy
facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 231948
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma /ID# 204983
city: Rome
country: Italy
facility: IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 227011
city: Nagoya-shi
country: Japan
facility: Chukyo Hospital /ID# 244755
state: Aichi
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital /ID# 207790
state: Aichi
city: Hirosaki-shi
country: Japan
facility: Hirosaki University Hospital /ID# 245023
state: Aomori
city: Chiba-shi
country: Japan
facility: Chiba University Hospital /ID# 232204
state: Chiba
city: Matsuyama-shi
country: Japan
facility: National Hospital Organization Shikoku Cancer Center /ID# 232252
state: Ehime
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center /ID# 206061
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 227776
state: Fukuoka
city: Fukuyama-shi
country: Japan
facility: Chugoku Central Hospital /ID# 245022
state: Hiroshima
city: Himeji-shi
country: Japan
facility: Himeji Medical Center /ID# 227777
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe Minimally Invasive Cancer Center /ID# 248590
state: Hyogo
city: Takarazuka-shi
country: Japan
facility: Takarazuka City Hospital /ID# 245185
state: Hyogo
city: Yokohama-shi
country: Japan
facility: Yokohama Municipal Citizen's Hospital /ID# 248374
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center /ID# 205068
state: Kanagawa
city: Matsusaka-shi
country: Japan
facility: Matsusaka Municipal Hospital /ID# 230219
state: Mie
city: Sendai-shi
country: Japan
facility: Sendai Kousei Hospital /ID# 216460
state: Miyagi
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital /ID# 216462
state: Niigata
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 227851
state: Okayama
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital /ID# 233172
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute /ID# 210735
state: Osaka
city: Sakai-shi
country: Japan
facility: Kinki-Chuo Chest Medical Center /ID# 216461
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center /ID# 232508
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center /ID# 205065
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 205066
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR /ID# 216463
state: Tokyo
city: Ube-shi
country: Japan
facility: Yamaguchi - Ube Medical Center /ID# 227778
state: Yamaguchi
city: Fujieda-shi
country: Japan
facility: Fujieda Municipal General Hospital /ID# 248589
city: Hiroshima-shi
country: Japan
facility: Hiroshima Citizens Hospital /ID# 218087
city: Goyang
country: Korea, Republic of
facility: National Cancer Center /ID# 204241
state: Gyeonggido
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital /ID# 204237
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 229647
state: Gyeonggido
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital /ID# 233871
state: Gyeongsangnamdo
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National Univ Hosp /ID# 205680
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital /ID# 234206
city: Jeonnam
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital /ID# 206951
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 204236
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 227083
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek /ID# 216657
state: Noord-Holland
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum /ID# 217756
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St. Jansdal /ID# 216658
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej /ID# 231476
state: Lodzkie
city: Warsaw
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 230595
state: Mazowieckie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio /ID# 231960
state: Podkarpackie
city: Poznan
country: Poland
facility: Med Polonia Sp. z o. o. /ID# 229908
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Dom Lekarski S.A. /ID# 231479
state: Zachodniopomorskie
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System /ID# 206336
city: San Juan
country: Puerto Rico
facility: Puerto Rico Hematology Oncolog /ID# 206337
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 227623
state: Dolj
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti /ID# 229097
state: Prahova
city: Bucharest
country: Romania
facility: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti /ID# 227216
city: Bucharest
country: Romania
facility: Spitalul Clinic Coltea /ID# 227241
city: Bucharest
country: Romania
facility: S.C. Gral Medical Srl /Id# 227215
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof Dr I Chiricuta /ID# 206320
city: Timisoara
country: Romania
facility: Oncomed SRL /ID# 205616
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncology Dispensary n.a. A.I. Kryzhanovsky /ID# 232065
state: Krasnoyarskiy Kray
city: Novosibirsk
country: Russian Federation
facility: LLC Medical Center /ID# 212397
state: Novosibirskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg scientific center for specialized medical care (oncological) /ID# 206405
state: Sankt-Peterburg
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary /ID# 206463
state: Tatarstan, Respublika
city: Volgograd
country: Russian Federation
facility: Regional Children's Clinical Hospital of Volgograd /ID# 206520
state: Volgogradskaya Oblast
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncology Dispensary /ID# 216418
city: Chelyabinsk
country: Russian Federation
facility: Evimed Clinic /ID# 216473
city: Kostroma
country: Russian Federation
facility: Kostroma region oncology center /ID# 231317
city: Moscow
country: Russian Federation
facility: Univercity Headache Clynic,LTD /ID# 212080
city: Moscow
country: Russian Federation
facility: VitaMed LLC /ID# 228957
city: Obninsk
country: Russian Federation
facility: National Medical Research Radiological Centre /ID# 231263
city: Omsk
country: Russian Federation
facility: Clinical Oncology Dispensary of Omsk /ID# 239313
city: Pushkin
country: Russian Federation
facility: Euromedservice /ID# 206390
city: Pyatigorsk
country: Russian Federation
facility: Newclinic Medical Center /ID# 216262
city: St. Petersburg
country: Russian Federation
facility: Center of Palliative Medicine De Vita /ID# 212900
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 204367
state: A Coruna
city: Badalona
country: Spain
facility: Instituto Catalan de Oncologia (ICO) Badalona /ID# 216106
state: Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: CHU Insular-Materno Infantil /ID# 232362
state: Las Palmas
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon /ID# 232361
state: Madrid
city: Avila
country: Spain
facility: Hospital Nuestra Senora de Sonsoles /ID# 232367
city: Barcelona
country: Spain
facility: Hospital Universitario Dexeus - Grupo Quironsalud /ID# 232368
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 206997
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 203922
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro /ID# 203913
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga /ID# 216081
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena /ID# 230998
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 216058
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 203862
city: Basel
country: Switzerland
facility: Universitätsspital Basel /ID# 230977
state: Basel-Stadt
city: Winterthur
country: Switzerland
facility: KSW Kantonsspital Winterthur /ID# 231284
state: Zuerich
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital /ID# 205423
state: Kaohsiung
city: Chia-Yi
country: Taiwan
facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 205309
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 205831
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital /ID# 215356
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital /ID# 205308
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 205307
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 205100
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center /ID# 227336
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 205424
city: Adana
country: Turkey
facility: Adana Sehir Egitim ve Arastirma Hastanesi /ID# 206000
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi /ID# 205243
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty /ID# 239816
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Tip Fakul /ID# 205238
city: Edirne, Istanbul
country: Turkey
facility: Trakya University Medical Facu /ID# 205242
city: Istanbul
country: Turkey
facility: Prof. Dr. Suleyman Yalcın Sehir Hastanesi /ID# 215082
city: Izmir
country: Turkey
facility: Dr. Suat Seren Gogus Has /ID# 215083
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 239889
state: London, City Of
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust /ID# 231224
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust /ID# 205890
state: Oxfordshire
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust /ID# 206209
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust /ID# 231467
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: