Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

Trial Title: Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

NCT ID: NCT03539536

Condition: Non-small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Non-small Cell Lung Cancer (NSCLC)
Cancer
Telisotuzumab vedotin
ABBV-399
c-Met, c-Met overexpression
metastatic
MET gene amplification
LUMINOSITY

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Telisotuzumab vedotin
Description: Intravenous (IV) infusion
Arm group label: Telisotuzumab vedotin

Other name: ABBV-399

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).

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of South Alabama /ID# 212939

Address:
City: Mobile
Zip: 36604-3302
Country: United States

Facility:
Name: Mayo Clinic Arizona /ID# 218550

Address:
City: Phoenix
Zip: 85054-4504
Country: United States

Facility:
Name: Highlands Oncology Group, PA /ID# 215600

Address:
City: Springdale
Zip: 72762
Country: United States

Facility:
Name: University of California, Los Angeles /ID# 203219

Address:
City: Los Angeles
Zip: 90095
Country: United States

Facility:
Name: LA Hematology-Oncology Med Group /ID# 203338

Address:
City: Orange
Zip: 92868
Country: United States

Facility:
Name: Sutter Medical Center Sacramen /ID# 203299

Address:
City: Sacramento
Zip: 95816
Country: United States

Facility:
Name: Icri /Id# 227835

Address:
City: Whittier
Zip: 90603
Country: United States

Facility:
Name: Univ of Colorado Cancer Center /ID# 203212

Address:
City: Aurora
Zip: 80045
Country: United States

Facility:
Name: Rocky Mountain Cancer Centers /ID# 215789

Address:
City: Lone Tree
Zip: 80124
Country: United States

Facility:
Name: Advanced Cancer Treatment Center /ID# 239565

Address:
City: Brooksville
Zip: 34613-6072
Country: United States

Facility:
Name: AdventHealth Celebration /ID# 215649

Address:
City: Celebration
Zip: 34747-4970
Country: United States

Facility:
Name: Mayo Clinic /ID# 218488

Address:
City: Jacksonville
Zip: 32224
Country: United States

Facility:
Name: AdventHealth Cancer Institute - Orlando /ID# 239960

Address:
City: Orlando
Zip: 32804
Country: United States

Facility:
Name: Straub Clinic and Hospital /ID# 217905

Address:
City: Honolulu
Zip: 96813-3097
Country: United States

Facility:
Name: Northwestern University Feinberg School of Medicine /ID# 203239

Address:
City: Chicago
Zip: 60611-2927
Country: United States

Facility:
Name: The University of Chicago Medical Center /ID# 203216

Address:
City: Chicago
Zip: 60637-1443
Country: United States

Facility:
Name: NorthShore University HealthSystem /ID# 215583

Address:
City: Evanston
Zip: 60201
Country: United States

Facility:
Name: Ingalls Memorial Hosp /ID# 203228

Address:
City: Harvey
Zip: 60426
Country: United States

Facility:
Name: Joliet Oncology-Hematology Associates, LTD /ID# 203238

Address:
City: Joliet
Zip: 60435
Country: United States

Facility:
Name: Goshen Center for Cancer Care /ID# 215584

Address:
City: Goshen
Zip: 46526
Country: United States

Facility:
Name: Univ Kansas Med Ctr /ID# 216804

Address:
City: Kansas City
Zip: 66160
Country: United States

Facility:
Name: Cancer Center of Kansas /ID# 203235

Address:
City: Wichita
Zip: 67214
Country: United States

Facility:
Name: Baptist Health /ID# 203283

Address:
City: Lexington
Zip: 40503-1463
Country: United States

Facility:
Name: Norton Cancer Institute - St Matthews /ID# 203284

Address:
City: Louisville
Zip: 40207
Country: United States

Facility:
Name: Central Maine Medical Center /ID# 216583

Address:
City: Lewiston
Zip: 04240
Country: United States

Facility:
Name: Massachusetts General Hospital /ID# 203215

Address:
City: Boston
Zip: 02114
Country: United States

Facility:
Name: Beth Israel Deaconess Medical Center /ID# 208124

Address:
City: Boston
Zip: 02215-5400
Country: United States

Facility:
Name: Dana-Farber Cancer Institute /ID# 203248

Address:
City: Boston
Zip: 02215
Country: United States

Facility:
Name: Henry Ford Hospital - West Bloomfield /ID# 203220

Address:
City: West Bloomfield
Zip: 48322
Country: United States

Facility:
Name: Mayo Clinic - Rochester /ID# 215603

Address:
City: Rochester
Zip: 55905-0001
Country: United States

Facility:
Name: Hattiesburg Clinic /ID# 227691

Address:
City: Hattiesburg
Zip: 39401
Country: United States

Facility:
Name: St. Lukes Cancer Institute /ID# 227697

Address:
City: Kansas City
Zip: 64111-5905
Country: United States

Facility:
Name: Washington University-School of Medicine /ID# 203217

Address:
City: Saint Louis
Zip: 63110
Country: United States

Facility:
Name: St. Vincent Frontier Cancer Center /ID# 203292

Address:
City: Billings
Zip: 59102
Country: United States

Facility:
Name: Dartmouth-Hitchcock Medical Center /ID# 203350

Address:
City: Lebanon
Zip: 03756
Country: United States

Facility:
Name: Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 228868

Address:
City: East Brunswick
Zip: 08816
Country: United States

Facility:
Name: Atlantic Health System /ID# 203404

Address:
City: Morristown
Zip: 07960-6136
Country: United States

Facility:
Name: Capital Health Medical Center /ID# 203403

Address:
City: Pennington
Zip: 08534-2520
Country: United States

Facility:
Name: Overlook Medical Center /ID# 211160

Address:
City: Summit
Zip: 07901-3533
Country: United States

Facility:
Name: University of New Mexico /ID# 208339

Address:
City: Albuquerque
Zip: 87102-4517
Country: United States

Facility:
Name: Gabrail Cancer Center Research /ID# 216056

Address:
City: Canton
Zip: 44718
Country: United States

Facility:
Name: Univ Hosp Cleveland /ID# 215648

Address:
City: Cleveland
Zip: 44106
Country: United States

Facility:
Name: Mercy Cancer Center /ID# 231972

Address:
City: Elyria
Zip: 44024
Country: United States

Facility:
Name: Mercy Research Mercy Clinic Oklahoma Communities, Inc. / OKC /ID# 230154

Address:
City: Oklahoma City
Zip: 73120
Country: United States

Facility:
Name: Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301

Address:
City: Portland
Zip: 97225
Country: United States

Facility:
Name: Penn State University and Milton S. Hershey Medical Center /ID# 221844

Address:
City: Hershey
Zip: 17033-2360
Country: United States

Facility:
Name: Allegheny General Hospital /ID# 215585

Address:
City: Pittsburgh
Zip: 15212
Country: United States

Facility:
Name: Veterans Healthcare System /ID# 215602

Address:
City: Pittsburgh
Zip: 15240
Country: United States

Facility:
Name: Thompson Cancer Survival Ctr /ID# 228874

Address:
City: Knoxville
Zip: 37916
Country: United States

Facility:
Name: Vanderbilt Ingram Cancer Center /ID# 203281

Address:
City: Nashville
Zip: 37232-0021
Country: United States

Facility:
Name: Houston Methodist Hospital - Scurlock Tower /ID# 213268

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: Baylor Scott & White Medical Center- Temple /ID# 216578

Address:
City: Temple
Zip: 76508-0001
Country: United States

Facility:
Name: Virginia Cancer Specialists - Fairfax /ID# 203224

Address:
City: Fairfax
Zip: 22031
Country: United States

Facility:
Name: Valley Medical Center /ID# 231459

Address:
City: Renton
Zip: 98055-5738
Country: United States

Facility:
Name: University of Washington /ID# 206056

Address:
City: Seattle
Zip: 98109
Country: United States

Facility:
Name: Medical College of Wisconsin /ID# 210062

Address:
City: Milwaukee
Zip: 53226-3522
Country: United States

Facility:
Name: The Kinghorn Cancer Centre /ID# 207666

Address:
City: Darlinghurst
Zip: 2010
Country: Australia

Facility:
Name: Newcastle Private Hospital /ID# 206600

Address:
City: Lambton Heights
Zip: 2305
Country: Australia

Facility:
Name: The Tweed Hospital /ID# 206601

Address:
City: Tweed Heads
Zip: 2485
Country: Australia

Facility:
Name: Mater Misericordiae Limited /ID# 229639

Address:
City: South Brisbane
Zip: 4101
Country: Australia

Facility:
Name: St John Of God Subiaco Hospital /ID# 226943

Address:
City: Subiaco
Zip: 6008
Country: Australia

Facility:
Name: Universitair Ziekenhuis Antwerpen /ID# 217430

Address:
City: Edegem
Zip: 2650
Country: Belgium

Facility:
Name: Hospital La Louviere Site Jolimont - Helora /ID# 230586

Address:
City: La Louvière
Zip: 7100
Country: Belgium

Facility:
Name: Vitaz /Id# 239966

Address:
City: Sint-Niklaas
Zip: 9100
Country: Belgium

Facility:
Name: Institut Jules Bordet /ID# 238614

Address:
City: Anderlecht
Zip: 1070
Country: Belgium

Facility:
Name: AZ Maria Middelares /ID# 233474

Address:
City: Gent
Zip: 9000
Country: Belgium

Facility:
Name: Jessa Ziekenhuis /ID# 234047

Address:
City: Hasselt
Zip: 3500
Country: Belgium

Facility:
Name: AZ Groeninge /ID# 217431

Address:
City: Kortrijk
Zip: 8500
Country: Belgium

Facility:
Name: CHU de Liege /ID# 230589

Address:
City: Liege
Zip: 4000
Country: Belgium

Facility:
Name: CHU UCL Namur - Sainte Elisabeth /ID# 234048

Address:
City: Namur
Zip: 5000
Country: Belgium

Facility:
Name: MHAT Dobrich /ID# 230074

Address:
City: Dobrich
Zip: 9300
Country: Bulgaria

Facility:
Name: UMHAT Dr Georgi Stranski EAD /ID# 232024

Address:
City: Pleven
Zip: 5800
Country: Bulgaria

Facility:
Name: Medical Center Nadezhda /ID# 230473

Address:
City: Sofia
Zip: 1330
Country: Bulgaria

Facility:
Name: Acibadem City Clinic Tokuda University Hospital EAD /ID# 232010

Address:
City: Sofia
Zip: 1407
Country: Bulgaria

Facility:
Name: Cross Cancer Institute /ID# 204540

Address:
City: Edmonton
Zip: T6G 1Z2
Country: Canada

Facility:
Name: Ottawa Hospital Research Institute /ID# 205579

Address:
City: Ottawa
Zip: K1H 8L6
Country: Canada

Facility:
Name: Princess Margaret Cancer Centre /ID# 204423

Address:
City: Toronto
Zip: M5G 2M9
Country: Canada

Facility:
Name: CISSS de la Monteregie /ID# 211356

Address:
City: Greenfield Park
Zip: J4V 2H1
Country: Canada

Facility:
Name: Anhui Provincial Hospital /ID# 212096

Address:
City: Hefei
Zip: 230001
Country: China

Facility:
Name: Anhui Chest Hospital /ID# 239048

Address:
City: Hefei
Zip: 230022
Country: China

Facility:
Name: Anhui Provincial Cancer Hospital /ID# 239058

Address:
City: Hefei
Zip: 230031
Country: China

Facility:
Name: Beijing Cancer Hospital /ID# 210133

Address:
City: Beijing
Zip: 100142
Country: China

Facility:
Name: Fujian Provincial Cancer Hospital /ID# 210808

Address:
City: Fuzhou
Zip: 350014
Country: China

Facility:
Name: The First Affiliated Hospital of Guangzhou Medical University /ID# 232261

Address:
City: Guangzhou
Zip: 510163
Country: China

Facility:
Name: Guangxi Medical University Cancer Center /ID# 231560

Address:
City: Nanning
Zip: 530027
Country: China

Facility:
Name: Affiliated Hospital of Hebei University /ID# 227262

Address:
City: Baoding
Zip: 071000
Country: China

Facility:
Name: Harbin Medical University Cancer Hospital /Id# 231573

Address:
City: Harbin
Zip: 150081
Country: China

Facility:
Name: Henan Cancer Hospital /ID# 210961

Address:
City: Zhengzhou
Zip: 450008
Country: China

Facility:
Name: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211119

Address:
City: Wuhan
Zip: 430022
Country: China

Facility:
Name: The First People's Hospital of Changzhou /ID# 210787

Address:
City: Changzhou
Zip: 213003
Country: China

Facility:
Name: Jilin Cancer Hospital /ID# 210563

Address:
City: Changchun
Zip: 130012
Country: China

Facility:
Name: Shandong Cancer Hospital /ID# 231577

Address:
City: Jinan
Zip: 251601
Country: China

Facility:
Name: Shanghai Chest Hospital /ID# 210930

Address:
City: Shanghai
Zip: 200030
Country: China

Facility:
Name: Fudan University Shanghai Cancer Center /Id# 210084

Address:
City: Shanghai
Zip: 200032
Country: China

Facility:
Name: West China Hospital, Sichuan University /ID# 210022

Address:
City: Chengdu
Zip: 610041
Country: China

Facility:
Name: The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 227244

Address:
City: Urumqi
Zip: 830000
Country: China

Facility:
Name: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 211154

Address:
City: Hangzhou
Zip: 310003
Country: China

Facility:
Name: Zhejiang Cancer hospital /ID# 210085

Address:
City: Hangzhou
Zip: 310022
Country: China

Facility:
Name: Vseobecna fakultni nemocnice v Praze /ID# 229797

Address:
City: Praha
Zip: 128 08
Country: Czechia

Facility:
Name: Multiscan s.r.o. /ID# 241926

Address:
City: Praha
Zip: 155 00
Country: Czechia

Facility:
Name: APHM - Hopital Nord /ID# 209854

Address:
City: Marseille
Zip: 13015
Country: France

Facility:
Name: Institut Bergonie /ID# 216207

Address:
City: Bordeaux
Zip: 33000
Country: France

Facility:
Name: CHU Lille - Hôpital Albert Calmette /ID# 205105

Address:
City: Lille
Zip: 59037
Country: France

Facility:
Name: Institut Curie /ID# 207046

Address:
City: Paris CEDEX 05
Zip: 75248
Country: France

Facility:
Name: HCL - Hopital Louis Pradel /ID# 216209

Address:
City: Bron
Zip: 69500
Country: France

Facility:
Name: Centre Leon Berard /ID# 205107

Address:
City: Lyon CEDEX 08
Zip: 69373
Country: France

Facility:
Name: Centre Hosp Intercommunal de Creteil /ID# 227108

Address:
City: Creteil
Zip: 94000
Country: France

Facility:
Name: Institut Gustave Roussy /ID# 205149

Address:
City: Villejuif Cedex
Zip: 94805
Country: France

Facility:
Name: CHU Strasbourg - Hopital Civil /ID# 208080

Address:
City: Strasbourg cedex
Zip: 67091
Country: France

Facility:
Name: CHI Toulon-La Seyne sur Mer /ID# 230545

Address:
City: Toulon
Zip: 83056
Country: France

Facility:
Name: Universitatsklinikum Mannheim /ID# 228798

Address:
City: Mannheim
Zip: 68167
Country: Germany

Facility:
Name: Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 232052

Address:
City: Augsburg
Zip: 86150
Country: Germany

Facility:
Name: Universitaetsklinikum Giessen /ID# 231856

Address:
City: Gießen
Zip: 35392
Country: Germany

Facility:
Name: Krankenhaus Martha-Maria Halle-Doelau /ID# 205442

Address:
City: Halle (Saale)
Zip: 06120
Country: Germany

Facility:
Name: Vivantes Klinikum Neukolln /ID# 205928

Address:
City: Berlin
Zip: 12351
Country: Germany

Facility:
Name: Asklepios Fachkliniken Muenchen-Gauting /ID# 207789

Address:
City: Gauting
Zip: 82131
Country: Germany

Facility:
Name: Evangelisches Krankenhaus Hamm /ID# 208043

Address:
City: Hamm
Zip: 59063
Country: Germany

Facility:
Name: Klinikum Kassel /ID# 205443

Address:
City: Kassel
Zip: 34125
Country: Germany

Facility:
Name: Pius-Hospital Oldenburg /ID# 211615

Address:
City: Oldenburg
Zip: 26121
Country: Germany

Facility:
Name: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 205528

Address:
City: Athens
Zip: 11527
Country: Greece

Facility:
Name: Metropolitan Hospital /ID# 205529

Address:
City: Piraeus
Zip: 18547
Country: Greece

Facility:
Name: University General Hospital of Heraklion PA.G.N.I /ID# 205530

Address:
City: Heraklion
Zip: 71500
Country: Greece

Facility:
Name: Bioclinic Thessaloniki /ID# 227261

Address:
City: Thessaloniki
Zip: 54622
Country: Greece

Facility:
Name: Euromedica General Clinic /ID# 227264

Address:
City: Thessaloniki
Zip: 54645
Country: Greece

Facility:
Name: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 204878

Address:
City: Encs
Zip: 3860
Country: Hungary

Facility:
Name: Torokbalinti Tudogyogyintezet /ID# 204883

Address:
City: Torokbalint
Zip: 2045
Country: Hungary

Facility:
Name: Semmelweis Egyetem /ID# 204434

Address:
City: Budapest
Zip: 1085
Country: Hungary

Facility:
Name: Duplicate_Veszprem Megyei Tudogyogyintez /ID# 213950

Address:
City: Farkasgyepu
Zip: 8582
Country: Hungary

Facility:
Name: Matrai Gyogyintezet /ID# 204432

Address:
City: Matrahaza
Zip: 3233
Country: Hungary

Facility:
Name: Cork University Hospital /ID# 205103

Address:
City: Wilton
Zip: T12 E8YV
Country: Ireland

Facility:
Name: Mater Misericordiae Univ Hospital /ID# 231466

Address:
City: Dublin 7
Zip: D07 R2WY
Country: Ireland

Facility:
Name: St James Hospital /ID# 205104

Address:
City: Dublin 8
Zip: D08 NHY1
Country: Ireland

Facility:
Name: St Vincent's University Hospital /ID# 205102

Address:
City: Elm Park
Zip: D04 T6F4
Country: Ireland

Facility:
Name: Rambam Health Care Campus /ID# 204866

Address:
City: Haifa
Zip: 3109601
Country: Israel

Facility:
Name: Rabin Medical Center /ID# 215322

Address:
City: Haifa
Zip: 4941492
Country: Israel

Facility:
Name: Soroka University Medical Center /ID# 204898

Address:
City: Be'er Sheva
Zip: 8443901
Country: Israel

Facility:
Name: Meir Medical Center /ID# 204255

Address:
City: Kfar Saba
Zip: 4428164
Country: Israel

Facility:
Name: The Chaim Sheba Medical Center /ID# 204254

Address:
City: Ramat Gan
Zip: 5265601
Country: Israel

Facility:
Name: Ospedale San Raffaele IRCCS /ID# 226973

Address:
City: Milan
Zip: 20132
Country: Italy

Facility:
Name: Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 215918

Address:
City: Rome
Zip: 00128
Country: Italy

Facility:
Name: Azienda Ospedaliera San Camillo Forlanini /ID# 205163

Address:
City: Rome
Zip: 00152
Country: Italy

Facility:
Name: A.O.U. San Luigi Gonzaga /ID# 204706

Address:
City: Orbassano
Zip: 10043
Country: Italy

Facility:
Name: L'Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Mos /ID# 204707

Address:
City: Avellino
Zip: 83100
Country: Italy

Facility:
Name: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 216153

Address:
City: Bologna
Zip: 40138
Country: Italy

Facility:
Name: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 205601

Address:
City: Meldola
Zip: 47014
Country: Italy

Facility:
Name: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 231948

Address:
City: Napoli
Zip: 80138
Country: Italy

Facility:
Name: Azienda Ospedaliero-Universitaria di Parma /ID# 204983

Address:
City: Parma
Zip: 43126
Country: Italy

Facility:
Name: IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 227011

Address:
City: Rome
Zip: 00144
Country: Italy

Facility:
Name: Chukyo Hospital /ID# 244755

Address:
City: Nagoya-shi
Zip: 457-8510
Country: Japan

Facility:
Name: Aichi Cancer Center Hospital /ID# 207790

Address:
City: Nagoya-shi
Zip: 464-8681
Country: Japan

Facility:
Name: Hirosaki University Hospital /ID# 245023

Address:
City: Hirosaki-shi
Zip: 036-8203
Country: Japan

Facility:
Name: Chiba University Hospital /ID# 232204

Address:
City: Chiba-shi
Zip: 260-8677
Country: Japan

Facility:
Name: National Hospital Organization Shikoku Cancer Center /ID# 232252

Address:
City: Matsuyama-shi
Zip: 791-0280
Country: Japan

Facility:
Name: National Hospital Organization Kyushu Cancer Center /ID# 206061

Address:
City: Fukuoka-shi
Zip: 811-1395
Country: Japan

Facility:
Name: Kurume University Hospital /ID# 227776

Address:
City: Kurume-shi
Zip: 830-0011
Country: Japan

Facility:
Name: Chugoku Central Hospital /ID# 245022

Address:
City: Fukuyama-shi
Zip: 720-0001
Country: Japan

Facility:
Name: Himeji Medical Center /ID# 227777

Address:
City: Himeji-shi
Zip: 670-8520
Country: Japan

Facility:
Name: Kobe Minimally Invasive Cancer Center /ID# 248590

Address:
City: Kobe-shi
Zip: 650-0046
Country: Japan

Facility:
Name: Takarazuka City Hospital /ID# 245185

Address:
City: Takarazuka-shi
Zip: 665-0827
Country: Japan

Facility:
Name: Yokohama Municipal Citizen's Hospital /ID# 248374

Address:
City: Yokohama-shi
Zip: 221-0855
Country: Japan

Facility:
Name: Kanagawa Cancer Center /ID# 205068

Address:
City: Yokohama-shi
Zip: 241-8515
Country: Japan

Facility:
Name: Matsusaka Municipal Hospital /ID# 230219

Address:
City: Matsusaka-shi
Zip: 515-8544
Country: Japan

Facility:
Name: Sendai Kousei Hospital /ID# 216460

Address:
City: Sendai-shi
Zip: 980-0873
Country: Japan

Facility:
Name: Niigata Cancer Center Hospital /ID# 216462

Address:
City: Niigata-shi
Zip: 951-8566
Country: Japan

Facility:
Name: Okayama University Hospital /ID# 227851

Address:
City: Okayama-shi
Zip: 700-8558
Country: Japan

Facility:
Name: Osaka City General Hospital /ID# 233172

Address:
City: Osaka-shi
Zip: 534-0021
Country: Japan

Facility:
Name: Osaka International Cancer Institute /ID# 210735

Address:
City: Osaka-shi
Zip: 541-8567
Country: Japan

Facility:
Name: Kinki-Chuo Chest Medical Center /ID# 216461

Address:
City: Sakai-shi
Zip: 591-8555
Country: Japan

Facility:
Name: Saitama Cancer Center /ID# 232508

Address:
City: Kitaadachi-gun
Zip: 362-0806
Country: Japan

Facility:
Name: Shizuoka Cancer Center /ID# 205065

Address:
City: Sunto-gun
Zip: 411-8777
Country: Japan

Facility:
Name: National Cancer Center Hospital /ID# 205066

Address:
City: Chuo-ku
Zip: 104-0045
Country: Japan

Facility:
Name: The Cancer Institute Hospital Of JFCR /ID# 216463

Address:
City: Koto-ku
Zip: 135-8550
Country: Japan

Facility:
Name: Yamaguchi - Ube Medical Center /ID# 227778

Address:
City: Ube-shi
Zip: 755-0241
Country: Japan

Facility:
Name: Fujieda Municipal General Hospital /ID# 248589

Address:
City: Fujieda-shi
Zip: 426-8677
Country: Japan

Facility:
Name: Hiroshima Citizens Hospital /ID# 218087

Address:
City: Hiroshima-shi
Zip: 730-8518
Country: Japan

Facility:
Name: National Cancer Center /ID# 204241

Address:
City: Goyang
Zip: 10408
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital /ID# 204237

Address:
City: Seongnam
Zip: 13620
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea, ST. Vincent's Hospital /ID# 229647

Address:
City: Suwon
Zip: 16247
Country: Korea, Republic of

Facility:
Name: Pusan National University Yangsan Hospital /ID# 233871

Address:
City: Yangsan-si
Zip: 50612
Country: Korea, Republic of

Facility:
Name: Chungbuk National Univ Hosp /ID# 205680

Address:
City: Cheongju
Zip: 28644
Country: Korea, Republic of

Facility:
Name: Inha University Hospital /ID# 234206

Address:
City: Incheon
Zip: 22332
Country: Korea, Republic of

Facility:
Name: Chonnam National University Hwasun Hospital /ID# 206951

Address:
City: Jeonnam
Zip: 58128
Country: Korea, Republic of

Facility:
Name: Asan Medical Center /ID# 204236

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center /ID# 227083

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Antoni van Leeuwenhoek /ID# 216657

Address:
City: Amsterdam
Zip: 1066 CX
Country: Netherlands

Facility:
Name: Meander Medisch Centrum /ID# 217756

Address:
City: Amersfoort
Zip: 3813 TZ
Country: Netherlands

Facility:
Name: Ziekenhuis St. Jansdal /ID# 216658

Address:
City: Harderwijk
Zip: 3844 DG
Country: Netherlands

Facility:
Name: Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej /ID# 231476

Address:
City: Lodz
Zip: 90-549
Country: Poland

Facility:
Name: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 230595

Address:
City: Warsaw
Zip: 02-781
Country: Poland

Facility:
Name: Wojewodzki Szpital im. Sw. Ojca Pio /ID# 231960

Address:
City: Przemysl
Zip: 37-700
Country: Poland

Facility:
Name: Med Polonia Sp. z o. o. /ID# 229908

Address:
City: Poznan
Zip: 60-693
Country: Poland

Facility:
Name: Dom Lekarski S.A. /ID# 231479

Address:
City: Szczecin
Zip: 70-784
Country: Poland

Facility:
Name: VA Caribbean Healthcare System /ID# 206336

Address:
City: San Juan
Zip: 00921-3201
Country: Puerto Rico

Facility:
Name: Puerto Rico Hematology Oncolog /ID# 206337

Address:
City: San Juan
Zip: 00959
Country: Puerto Rico

Facility:
Name: S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 227623

Address:
City: Craiova
Zip: 200347
Country: Romania

Facility:
Name: Spitalul Municipal Ploiesti /ID# 229097

Address:
City: Ploiesti
Zip: 100337
Country: Romania

Facility:
Name: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti /ID# 227216

Address:
City: Bucharest
Zip: 022328
Country: Romania

Facility:
Name: Spitalul Clinic Coltea /ID# 227241

Address:
City: Bucharest
Zip: 030171
Country: Romania

Facility:
Name: S.C. Gral Medical Srl /Id# 227215

Address:
City: Bucharest
Zip: 031422
Country: Romania

Facility:
Name: Institutul Oncologic Prof Dr I Chiricuta /ID# 206320

Address:
City: Cluj Napoca
Zip: 400015
Country: Romania

Facility:
Name: Oncomed SRL /ID# 205616

Address:
City: Timisoara
Zip: 300239
Country: Romania

Facility:
Name: Krasnoyarsk Regional Clinical Oncology Dispensary n.a. A.I. Kryzhanovsky /ID# 232065

Address:
City: Krasnoyarsk
Zip: 660133
Country: Russian Federation

Facility:
Name: LLC Medical Center /ID# 212397

Address:
City: Novosibirsk
Zip: 630099
Country: Russian Federation

Facility:
Name: St. Petersburg scientific center for specialized medical care (oncological) /ID# 206405

Address:
City: Saint Petersburg
Zip: 197758
Country: Russian Federation

Facility:
Name: Republican Clinical Oncology Dispensary /ID# 206463

Address:
City: Kazan
Zip: 420029
Country: Russian Federation

Facility:
Name: Regional Children's Clinical Hospital of Volgograd /ID# 206520

Address:
City: Volgograd
Zip: 400138
Country: Russian Federation

Facility:
Name: Arkhangelsk Clinical Oncology Dispensary /ID# 216418

Address:
City: Arkhangelsk
Zip: 163045
Country: Russian Federation

Facility:
Name: Evimed Clinic /ID# 216473

Address:
City: Chelyabinsk
Zip: 454048
Country: Russian Federation

Facility:
Name: Kostroma region oncology center /ID# 231317

Address:
City: Kostroma
Zip: 156005
Country: Russian Federation

Facility:
Name: Univercity Headache Clynic,LTD /ID# 212080

Address:
City: Moscow
Zip: 109028
Country: Russian Federation

Facility:
Name: VitaMed LLC /ID# 228957

Address:
City: Moscow
Zip: 121309
Country: Russian Federation

Facility:
Name: National Medical Research Radiological Centre /ID# 231263

Address:
City: Obninsk
Zip: 249036
Country: Russian Federation

Facility:
Name: Clinical Oncology Dispensary of Omsk /ID# 239313

Address:
City: Omsk
Zip: 644013
Country: Russian Federation

Facility:
Name: Euromedservice /ID# 206390

Address:
City: Pushkin
Zip: 196603
Country: Russian Federation

Facility:
Name: Newclinic Medical Center /ID# 216262

Address:
City: Pyatigorsk
Zip: 357519
Country: Russian Federation

Facility:
Name: Center of Palliative Medicine De Vita /ID# 212900

Address:
City: St. Petersburg
Zip: 197343
Country: Russian Federation

Facility:
Name: Hospital Clínico Universitario de Santiago-CHUS /ID# 204367

Address:
City: Santiago de Compostela
Zip: 15706
Country: Spain

Facility:
Name: Instituto Catalan de Oncologia (ICO) Badalona /ID# 216106

Address:
City: Badalona
Zip: 08916
Country: Spain

Facility:
Name: CHU Insular-Materno Infantil /ID# 232362

Address:
City: Las Palmas de Gran Canaria
Zip: 35016
Country: Spain

Facility:
Name: Hospital Universitario Fundacion Alcorcon /ID# 232361

Address:
City: Alcorcon
Zip: 28922
Country: Spain

Facility:
Name: Hospital Nuestra Senora de Sonsoles /ID# 232367

Address:
City: Avila
Zip: 05004
Country: Spain

Facility:
Name: Hospital Universitario Dexeus - Grupo Quironsalud /ID# 232368

Address:
City: Barcelona
Zip: 08028
Country: Spain

Facility:
Name: Hospital Universitario Vall d'Hebron /ID# 206997

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital Universitario Ramon y Cajal /ID# 203922

Address:
City: Madrid
Zip: 28034
Country: Spain

Facility:
Name: Hospital Universitario HM Sanchinarro /ID# 203913

Address:
City: Madrid
Zip: 28050
Country: Spain

Facility:
Name: Hospital Regional Universitario de Malaga /ID# 216081

Address:
City: Malaga
Zip: 29011
Country: Spain

Facility:
Name: Hospital Universitario Virgen Macarena /ID# 230998

Address:
City: Sevilla
Zip: 41009
Country: Spain

Facility:
Name: Hospital Universitario Virgen del Rocio /ID# 216058

Address:
City: Sevilla
Zip: 41013
Country: Spain

Facility:
Name: Hospital Universitario y Politecnico La Fe /ID# 203862

Address:
City: Valencia
Zip: 46026
Country: Spain

Facility:
Name: Universitätsspital Basel /ID# 230977

Address:
City: Basel
Zip: 4031
Country: Switzerland

Facility:
Name: KSW Kantonsspital Winterthur /ID# 231284

Address:
City: Winterthur
Zip: 8400
Country: Switzerland

Facility:
Name: Kaohsiung Chang Gung Memorial Hospital /ID# 205423

Address:
City: Kaohsiung City
Zip: 833
Country: Taiwan

Facility:
Name: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 205309

Address:
City: Chia-Yi
Zip: 62247
Country: Taiwan

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 205831

Address:
City: Kaohsiung
Zip: 807
Country: Taiwan

Facility:
Name: Taipei Medical University Shuang Ho Hospital /ID# 215356

Address:
City: New Taipei City
Zip: 23561
Country: Taiwan

Facility:
Name: Taichung Veterans General Hospital /ID# 205308

Address:
City: Taichung
Zip: 40705
Country: Taiwan

Facility:
Name: National Cheng Kung University Hospital /ID# 205307

Address:
City: Tainan
Zip: 704
Country: Taiwan

Facility:
Name: National Taiwan University Hospital /ID# 205100

Address:
City: Taipei City
Zip: 100
Country: Taiwan

Facility:
Name: Koo Foundation Sun Yat-Sen Cancer Center /ID# 227336

Address:
City: Taipei
Zip: 112
Country: Taiwan

Facility:
Name: Linkou Chang Gung Memorial Hospital /ID# 205424

Address:
City: Taoyuan City
Zip: 333
Country: Taiwan

Facility:
Name: Adana Sehir Egitim ve Arastirma Hastanesi /ID# 206000

Address:
City: Adana
Zip: 01060
Country: Turkey

Facility:
Name: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi /ID# 205243

Address:
City: Ankara
Zip: 06200
Country: Turkey

Facility:
Name: Gazi University Medical Faculty /ID# 239816

Address:
City: Ankara
Zip: 06560
Country: Turkey

Facility:
Name: Akdeniz Universitesi Tip Fakul /ID# 205238

Address:
City: Antalya
Zip: 07059
Country: Turkey

Facility:
Name: Trakya University Medical Facu /ID# 205242

Address:
City: Edirne, Istanbul
Zip: 22030
Country: Turkey

Facility:
Name: Prof. Dr. Suleyman Yalcın Sehir Hastanesi /ID# 215082

Address:
City: Istanbul
Zip: 34722
Country: Turkey

Facility:
Name: Dr. Suat Seren Gogus Has /ID# 215083

Address:
City: Izmir
Zip: 35110
Country: Turkey

Facility:
Name: Barts Health NHS Trust /ID# 239889

Address:
City: London
Zip: E1 2ES
Country: United Kingdom

Facility:
Name: Nottingham University Hospitals NHS Trust /ID# 231224

Address:
City: Nottingham
Zip: NG5 1PB
Country: United Kingdom

Facility:
Name: Oxford University Hospitals NHS Foundation Trust /ID# 205890

Address:
City: Oxford
Zip: OX3 9DU
Country: United Kingdom

Facility:
Name: University Hospitals Birmingham NHS Foundation Trust /ID# 206209

Address:
City: Birmingham
Zip: B15 2TH
Country: United Kingdom

Facility:
Name: University College London Hospitals NHS Foundation Trust /ID# 231467

Address:
City: London
Zip: NW1 2PG
Country: United Kingdom

Start date: October 10, 2018

Completion date: October 6, 2025

Lead sponsor:
Agency: AbbVie
Agency class: Industry

Source: AbbVie

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT03539536