Clinical trial NCT04928846: A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Official title: A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Keywords: c-Met Overexpressing Non-Small Cell Lung Cancer
c-Met NSCLC
Telisotuzumab Vedotin
ABBV-399
Docetaxel
Cancer
Non Small Cell Lung Cancer
NSCLC
TeliMET NSCLC-01
Teliso-V
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-06-16
Enrollment: 698
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed.

Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 300 sites worldwide.

Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* Projected life expectancy of at least 12 weeks.
* Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
* Archival or fresh tumor material must be submitted for assessment of c-Met levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.

  * If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
* A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
* A known epidermal growth factor receptor (EGFR) activating mutation status.
* Actionable alterations in genes other than EGFR .
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
* Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.

  * Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
* Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC:

  * Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
  * Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase \[ALK\] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.

    * Participants with actionable gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
* Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
* Participants with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:

  * They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day \[QD\] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.

Exclusion Criteria:

* Evidence of new, untreated CNS metastases.
* Evidence of leptomeningeal disease.
* Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
* Actionable epidermal growth factor receptor (EGFR) activating mutations.
* Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
* Participants who have received prior docetaxel therapy.
* A history of other malignancies except:

  * Malignancy treated with curative intent and with no known active disease present for \>=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator.
  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  * Adequately treated carcinoma in situ without current evidence of disease.
* A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
* Unresolved or neuroendocrine histology, nor sarcomatoid features adverse event (AE) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
* Major surgery within 21 days prior to randomization.
* Clinically significant condition(s) as listed in the protocol.

Primary outcomes:
measure: Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 39 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 39 months
Secondary outcomes:
measure: Objective Response Rate (ORR), per BICR.
timeFrame: Up to approximately 58.25 months
measure: Duration of Response (DoR), per BICR
timeFrame: Up to approximately 58.25 months
measure: PFS per Investigator Assessment
timeFrame: Up to approximately 58.25 months
measure: Change from Baseline of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).
timeFrame: Up to approximately 12 Weeks
measure: Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30.
timeFrame: Up to approximately 12 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Main /ID# 247074
state: Alabama
city: Chandler
country: United States
facility: Ironwood Cancer & Res Ctr /ID# 262446
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Arizona /ID# 255858
state: Arizona
city: Yuma
country: United States
facility: Onvida Health Yuma Medical Center /ID# 253625
state: Arizona
city: Duarte
country: United States
facility: City of Hope /ID# 243157
state: California
city: Huntington Beach
country: United States
facility: City Of Hope - Seacliff /ID# 263143
state: California
city: Irvine
country: United States
facility: City of Hope Orange County Lennar Foundation Cancer Center /ID# 263144
state: California
city: Lancaster
country: United States
facility: City of Hope - Antelope Valley /ID# 263138
state: California
city: Los Angeles
country: United States
facility: The Oncology Institute of Hope and Innovation - DTLA /ID# 239774
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 253954
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center /ID# 233189
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic /ID# 254688
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228
state: Florida
city: Tamarac
country: United States
facility: BRCR Medical Center Inc /ID# 262344
state: Florida
city: Savannah
country: United States
facility: Memorial University Medical Center /ID# 264081
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Moanalua Medical Center /ID# 238363
state: Hawaii
city: Elmhurst
country: United States
facility: Edward-Elmhurst Cancer Center /ID# 238552
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic /ID# 262290
state: Illinois
city: Goshen
country: United States
facility: Goshen Center for Cancer Care /ID# 257734
state: Indiana
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana - Indianapolis /ID# 260468
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexington /ID# 252769
state: Kentucky
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 247132
state: Massachusetts
city: Ypsilanti
country: United States
facility: Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 252052
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic /ID# 248033
state: Mississippi
city: Chesterfield
country: United States
facility: St. Luke's Hospital - Chesterfield /ID# 251688
state: Missouri
city: Kansas City
country: United States
facility: St. Luke's Hosp. of Kansas City /ID# 259940
state: Missouri
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University Cancer Center /ID# 260722
state: Missouri
city: Springfield
country: United States
facility: Hulston Cancer Center /ID# 232226
state: Missouri
city: Billings
country: United States
facility: Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147
state: Montana
city: Lincoln
country: United States
facility: Nebraska Hematology Oncology /ID# 257710
state: Nebraska
city: Reno
country: United States
facility: Renown Medical Group - Oncology/Hematology /ID# 247942
state: Nevada
city: East Brunswick
country: United States
facility: Astera Cancer Care /ID# 257753
state: New Jersey
city: Farmington
country: United States
facility: San Juan Oncology Associates /ID# 244387
state: New Mexico
city: Brooklyn
country: United States
facility: Maimonides Medical Center /ID# 240783
state: New York
city: Lake Success
country: United States
facility: Northwell Health - Monter Cancer Center /ID# 247081
state: New York
city: Hendersonville
country: United States
facility: AdventHealth Hendersonville /ID# 265349
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth of the Carolinas- Speciality Center /ID# 241279
state: North Carolina
city: Zanesville
country: United States
facility: Genesis Cancer Care Center /ID# 239190
state: Ohio
city: York
country: United States
facility: Cancer Care Associates Of York /ID# 266143
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 251383
state: South Carolina
city: Greenville
country: United States
facility: St Francis Cancer Center /ID# 243596
state: South Carolina
city: Aberdeen
country: United States
facility: Avera Cancer Institute - Aberdeen /ID# 257759
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Institute /ID# 239635
state: South Dakota
city: Memphis
country: United States
facility: Memphis VA Medical Center /ID# 263250
state: Tennessee
city: Austin
country: United States
facility: Dell Seton Medical Center /ID# 247016
state: Texas
city: Ogden
country: United States
facility: Community Cancer Trials of Utah - South Ogden /ID# 262829
state: Utah
city: Renton
country: United States
facility: Valley Medical Center /ID# 253950
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates /ID# 247003
state: Washington
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Centro Médico Austral /ID# 239860
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Cenit /Id# 239880
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Hospital Britanico de Buenos Aires /ID# 231495
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Cemic /Id# 231486
state: Ciudad Autonoma De Buenos Aires
city: Viedma
country: Argentina
facility: Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339
state: Rio Negro
city: Geelong
country: Australia
facility: Barwon Health /ID# 241920
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health /ID# 247507
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 240967
state: Oberoesterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH /ID# 249000
state: Oberoesterreich
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck /ID# 240981
state: Tirol
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch /ID# 250333
state: Vorarlberg
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 230615
state: Wien
city: Vienna
country: Austria
facility: Klinik Penzing /ID# 230700
state: Wien
city: Vienna
country: Austria
facility: Klinik Floridsdorf /ID# 230608
state: Wien
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467
city: Brasschaat
country: Belgium
facility: Algemeen Ziekenhuis klina /ID# 239853
state: Antwerpen
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen /ID# 239971
state: Antwerpen
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi - Les Viviers /ID# 234178
state: Hainaut
city: La Louvière
country: Belgium
facility: Hospital La Louviere Site Jolimont - Helora /ID# 246771
state: Hainaut
city: Liège
country: Belgium
facility: CHU de Liège /ID# 246772
state: Liege
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis /ID# 246766
state: Limburg
city: Sint-Niklaas
country: Belgium
facility: Vitaz /Id# 246773
state: Oost-Vlaanderen
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet /ID# 246770
city: Gent
country: Belgium
facility: AZ Maria Middelares /ID# 246768
city: Namur
country: Belgium
facility: UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 246769
city: Salvador
country: Brazil
facility: Ensino e Terapia de Inovacao - Clinica AMO /ID# 231604
state: Bahia
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 233249
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital Sírio Libanês /ID# 261827
state: Sao Paulo
city: São Paulo
country: Brazil
facility: OC Oncoclínicas SP /ID# 261828
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer (INCA) /ID# 231509
city: Rio de Janeiro
country: Brazil
facility: Instituto D'or de Pesquisa e Ensino /ID# 233245
city: Sao Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417
city: Sao Paulo
country: Brazil
facility: Casa de Saúde Santa Marcelina /ID# 231605
city: Sofiya
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sofiamed /ID# 234108
state: Sofia
city: Burgas
country: Bulgaria
facility: Complex Oncology Center - Burgas /ID# 240532
city: Plovdiv
country: Bulgaria
facility: Complex Cancer Center Plovdiv /ID# 234106
city: Varna
country: Bulgaria
facility: UMHAT Sveta Marina /ID# 234112
city: Edmonton
country: Canada
facility: Cross Cancer Institute /ID# 252065
state: Alberta
city: Brampton
country: Canada
facility: William Osler Health System - Brampton Civic Hospital /ID# 254420
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie /ID# 239081
state: Quebec
city: Talca
country: Chile
facility: Clinica Universidad Catolica del Maule /ID# 231294
state: Maule
city: La Florida
country: Chile
facility: Icegclinic /Id# 231212
state: Region Metropolitana De Santiago
city: Providencia
country: Chile
facility: Sociedad Prosalud Montes y Orlandi /ID# 231154
state: Region Metropolitana De Santiago
city: Providencia
country: Chile
facility: Fundacion Arturo Lopez Perez /ID# 231151
state: Region Metropolitana De Santiago
city: Providencia
country: Chile
facility: Sociedad Oncovida /ID# 231152
state: Region Metropolitana De Santiago
city: Hefei
country: China
facility: Anhui Medical University - Anhui Chest Hospital /ID# 231899
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital /ID# 231923
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 233175
state: Beijing
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University /ID# 232202
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University /ID# 251592
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital /ID# 243134
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University /ID# 242381
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital Of Guangzhou Medical University /ID# 238591
state: Guangdong
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College /ID# 242182
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical College /ID# 233317
state: Guangdong
city: Nanning
country: China
facility: Affiliated Cancer Hospital of Guangxi Medical University /ID# 231855
state: Guangxi
city: Guiyang
country: China
facility: People's Hospital of Guizhou Province /ID# 243614
state: Guizhou
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University /ID# 239586
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital /Id# 231941
state: Heilongjiang
city: Nanyang
country: China
facility: The First affiliated Hospital of Nanyang Medical College /ID# 244652
state: Henan
city: Zhengzhou
country: China
facility: People's Hospital of Henan Province /ID# 242187
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital /ID# 239577
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231904
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of HUST /ID# 239575
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital /ID# 240045
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital /ID# 231943
state: Hunan
city: Huhehaote
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University /ID# 242179
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital /ID# 231791
state: Jiangsu
city: Nantong
country: China
facility: Nantong Tumor Hospital /ID# 232424
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University /ID# 231934
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University /ID# 231935
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital /ID# 244702
state: Jilin
city: Dalian
country: China
facility: The Second Affiliated Hospital of Dalian Medical University /ID# 239755
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University /ID# 231924
state: Liaoning
city: Xian
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University /ID# 232023
state: Shaanxi
city: Jinan
country: China
facility: Shandong University - Jinan Central Hospital /ID# 231895
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital /ID# 251506
state: Shandong
city: Linyi
country: China
facility: LinYi Cancer Hospital /ID# 239713
state: Shandong
city: Shanghai
country: China
facility: Shanghai Chest Hospital /ID# 231897
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital /ID# 258674
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Cancer Hospital /ID# 239707
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 233703
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Cancer Hospital /ID# 233176
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital /ID# 231839
state: Tianjin
city: Urumqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 240094
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Cancer Hospital /ID# 251388
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 232032
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer hospital /ID# 242476
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province /ID# 232021
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo No. 2 Hospital /ID# 242478
state: Zhejiang
city: Bogota
country: Colombia
facility: Fundacion CTIC - Centro de tratamiento e investigacion sobre cancer Luis Carlos /ID# 258131
state: Distrito Capital De Bogota
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav /ID# 232426
city: Novy Jicin
country: Czechia
facility: Nemocnice AGEL Novy Jicin, a.s. /ID# 232427
city: Roskilde
country: Denmark
facility: Roskilde Sygehus /ID# 241842
state: Sjælland
city: Odense
country: Denmark
facility: Odense University Hospital /ID# 241663
state: Syddanmark
city: Marseille
country: France
facility: APHM - Hopital Nord /ID# 251935
state: Bouches-du-Rhone
city: Pessac CEDEX
country: France
facility: Centre Hospitalier Universitaire de Bordeaux /ID# 244953
state: Gironde
city: Lille
country: France
facility: CHU Lille - Hôpital Albert Calmette /ID# 251934
state: Hauts-de-France
city: Montpellier Cedex 5
country: France
facility: Hopital Arnaud de Villeneuve /ID# 239404
state: Herault
city: Paris CEDEX 05
country: France
facility: Institut Curie /ID# 240141
state: Paris
city: Paris CEDEX 14
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 239409
state: Paris
city: Bron
country: France
facility: Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 251933
state: Rhone
city: Lyon CEDEX 08
country: France
facility: Centre Leon Berard /ID# 267397
state: Rhone
city: Creteil
country: France
facility: Centre Hosp Intercommunal de Creteil /ID# 251936
state: Val-de-Marne
city: Paris
country: France
facility: AP-HP - Hopital Tenon /ID# 239179
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH /ID# 239656
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim /ID# 238331
state: Baden-Wuerttemberg
city: Gießen
country: Germany
facility: Universitaetsklinikum Giessen /ID# 252973
state: Hessen
city: Kassel
country: Germany
facility: Klinikum Kassel /ID# 240142
state: Hessen
city: Jena
country: Germany
facility: Universitaetsklinikum Jena /ID# 239661
state: Thueringen
city: Berlin
country: Germany
facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 234247
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf /ID# 239658
city: Hamburg
country: Germany
facility: Haemato-Onkologie Hamburg /ID# 241047
city: Athens
country: Greece
facility: Henry Dunnant Hospital Center /ID# 267021
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 230824
state: Attiki
city: Piraeus
country: Greece
facility: Metropolitan Hospital /ID# 232158
state: Attiki
city: Piraeus
country: Greece
facility: Metropolitan Hospital /ID# 239170
state: Attiki
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic /ID# 254407
city: Ashkelon
country: Israel
facility: The Edith Wolfson Medical Center /ID# 233781
state: HaDarom
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center /ID# 252711
state: HaDarom
city: Safed
country: Israel
facility: ZIV Medical Center /ID# 238606
state: HaTsafon
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 260519
state: Tel-Aviv
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele /ID# 254376
state: Milano
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 252942
state: Napoli
city: Rome
country: Italy
facility: Azienda Ospedaliera Complesso Ospedaliero San Giovanni-Addolorata /ID# 238618
state: Roma
city: Bari
country: Italy
facility: I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696
city: Cremona
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Cremona /ID# 238698
city: Messina
country: Italy
facility: Azienda Ospedaliera Papardo /ID# 258038
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 238473
city: Varese
country: Italy
facility: ASST Sette Laghi - Ospedale Di Circolo E Fondazione Macchi Varese /ID# 238536
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center /ID# 246306
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital /ID# 239990
state: Aichi
city: Hirosaki-shi
country: Japan
facility: Hirosaki University Hospital /ID# 242377
state: Aomori
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 233775
state: Chiba
city: Fukuoka shi
country: Japan
facility: National Hospital Organization Kyushu Medical Center /ID# 238533
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan /ID# 241191
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 254900
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital /ID# 249691
state: Fukushima
city: Ota-shi
country: Japan
facility: Gunma Prefectural Cancer Center /ID# 233723
state: Gunma
city: Fukuyama
country: Japan
facility: Chugoku Central Hospital /ID# 242970
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital /ID# 241882
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 241289
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe Minimally Invasive Cancer Center /ID# 254131
state: Hyogo
city: Takarazuka-shi
country: Japan
facility: Takarazuka City Hospital /ID# 240786
state: Hyogo
city: Higashiibaraki-gun
country: Japan
facility: NHO Mito Medical Center /ID# 241709
state: Ibaraki
city: Kasama-shi
country: Japan
facility: Ibaraki Prefectural Central Hospital /ID# 246145
state: Ibaraki
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital /ID# 239027
state: Iwate
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital /ID# 239958
state: Kanagawa
city: Yokohama shi
country: Japan
facility: Yokohama City University Medical Center /ID# 246554
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center /ID# 239052
state: Kanagawa
city: Kumamoto shi
country: Japan
facility: Kumamoto University Hospital /ID# 241039
state: Kumamoto
city: Tsu-shi
country: Japan
facility: National Hospital Organization Mie Chuo Medical Center /ID# 246659
state: Mie
city: Natori-shi
country: Japan
facility: Miyagi Cancer Center /ID# 234198
state: Miyagi
city: Sendai-shi
country: Japan
facility: Sendai Kousei Hospital /ID# 253350
state: Miyagi
city: Miyazaki-shi
country: Japan
facility: University of Miyazaki Hospital /ID# 242161
state: Miyazaki
city: Nagaoka-shi
country: Japan
facility: Nagaoka Red Cross Hospital /ID# 240714
state: Niigata
city: Kurashiki-shi
country: Japan
facility: Kurashiki Central Hospital /ID# 239344
state: Okayama
city: Habikino-shi
country: Japan
facility: Osaka Habikino Medical Center /ID# 239989
state: Osaka
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 233476
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital /ID# 238895
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 239085
state: Osaka
city: Fujieda-shi
country: Japan
facility: Fujieda Municipal General Hospital /ID# 255155
state: Shizuoka
city: Utsunomiya-shi
country: Japan
facility: Tochigi Cancer Center /ID# 240020
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 239932
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 251134
state: Tokyo
city: Meguro-ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center /ID# 246581
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo /ID# 241067
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital /ID# 239506
state: Tokyo
city: Toyama-shi
country: Japan
facility: Toyama University Hospital /ID# 241660
state: Toyama
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital /ID# 234004
state: Wakayama
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital /ID# 240815
state: Yamagata
city: Ube-shi
country: Japan
facility: Yamaguchi - Ube Medical Center /ID# 258779
state: Yamaguchi
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital /ID# 257891
state: Chungcheongbugdo
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center /ID# 260663
state: Gyeonggido
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center /ID# 233318
state: Gyeonggido
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 233319
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital /ID# 256942
state: Gyeonggido
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital /ID# 234244
state: Gyeongsangnamdo
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital /ID# 257836
state: Gyeongsangnamdo
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital /ID# 233711
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 256941
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center /ID# 233710
state: Seoul Teugbyeolsi
city: Guadalajara
country: Mexico
facility: O.P.D. Hospital Civil de Guadalajara /ID# 238488
state: Jalisco
city: Morelia
country: Mexico
facility: Centro de Investigacion Clínica Chapultepec SA de CV /ID# 231928
state: Michoacan
city: Oaxaca
country: Mexico
facility: Clinical Research & Oncology Oaxaca /ID# 231883
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St. Jansdal /ID# 251932
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum /ID# 233932
state: Limburg
city: Zwolle
country: Netherlands
facility: Isala /ID# 238846
state: Overijssel
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis /ID# 243693
state: Zuid-Holland
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki /ID# 239024
state: Lodzkie
city: Warsaw
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 262095
state: Mazowieckie
city: Rzeszow
country: Poland
facility: MRUK-MED I Sp. z o.o. /ID# 239363
state: Podkarpackie
city: Olsztyn
country: Poland
facility: Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 239025
state: Warminsko-mazurskie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 262489
state: Wielkopolskie
city: Lisbon
country: Portugal
facility: Fundacao Champalimaud /ID# 241925
state: Lisboa
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 241572
city: Porto
country: Portugal
facility: Hospital CUF Porto /ID# 241570
city: Porto
country: Portugal
facility: IPO Porto FG, EPE /ID# 241569
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 241930
city: Oradea
country: Romania
facility: Spitalul Pelican /ID# 254066
state: Bihor
city: Cluj-Napoca
country: Romania
facility: Cardiomed Srl /Id# 255320
state: Cluj
city: Craiova
country: Romania
facility: Sc Oncolab Srl /Id# 239105
state: Dolj
city: Jassi
country: Romania
facility: Institutul Regional de Oncologie /ID# 254065
state: Iasi
city: Otopeni
country: Romania
facility: SC RTC Radiology Therapeutic Center SRL /ID# 240744
state: Ilfov
city: Timisoara
country: Romania
facility: Oncocenter - Oncologie Clinica Srl /Id# 239103
state: Timis
city: Brasov
country: Romania
facility: Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 240826
city: Suceava
country: Romania
facility: S.C. Sigmedical Services SRL /ID# 239108
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 230084
state: Banskobystricky Kraj
city: Johannesburg
country: South Africa
facility: Wits Clinical Research /ID# 230841
state: Gauteng
city: Johannesburg
country: South Africa
facility: Sandton Oncology Medical Group PTY Ltd /ID# 230843
state: Gauteng
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital /ID# 230883
state: Gauteng
city: Las Palmas de Gran Canaria
country: Spain
facility: CHU Insular-Materno Infantil /ID# 255094
state: Las Palmas
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon /ID# 255100
state: Madrid
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada /ID# 255093
state: Madrid
city: Avila
country: Spain
facility: Hospital Nuestra Senora de Sonsoles /ID# 255102
city: Barcelona
country: Spain
facility: UOMi Cancer Center - Clinica Tres Torres /ID# 240584
city: Barcelona
country: Spain
facility: Hospital Universitario Dexeus - Grupo Quironsalud /ID# 255105
city: Jaen
country: Spain
facility: Hospital Universitario de Jaen /ID# 240588
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 240176
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia /ID# 240378
city: Solna
country: Sweden
facility: Karolinska University Hospital Solna /ID# 229853
state: Stockholms Lan
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset /ID# 229943
state: Vastra Gotalands Lan
city: Kaohsiung City
country: Taiwan
facility: E-DA Cancer Hospital /ID# 239718
state: Kaohsiung
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 238378
state: Taipei
city: Changhua City, Changhua County
country: Taiwan
facility: Changhua Christian Hospital /ID# 238394
city: Hsinchu City
country: Taiwan
facility: National Taiwan University Hospital - Hsinchu branch /ID# 238393
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital /ID# 238398
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital /ID# 238444
city: Taipei City
country: Taiwan
facility: Mackay Memorial Hospital /ID# 238392
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital /ID# 238380
city: Çankaya
country: Turkey
facility: Memorial Ankara Hastanesi /ID# 234212
state: Ankara
city: Karsiyaka
country: Turkey
facility: Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 234209
state: Izmir
city: Adana
country: Turkey
facility: Adana Sehir Egitim ve Arastirma Hastanesi /ID# 255638
city: Adana
country: Turkey
facility: Adana Acıbadem Hospital /ID# 234208
city: Adana
country: Turkey
facility: Medical Park Seyhan Hastanesi /ID# 255637
city: Ankara
country: Turkey
facility: Ankara City Hospital /ID# 234210
city: Battalgazi/malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal /ID# 234038
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty /ID# 234205
city: Diyarbakir
country: Turkey
facility: Dicle Universitesi Tip /ID# 234036
city: Istanbul
country: Turkey
facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 234211
city: Izmir
country: Turkey
facility: Ege University Medical Faculty /ID# 234039
city: London
country: United Kingdom
facility: Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 254342
state: Greater London
city: London
country: United Kingdom
facility: University College London Hospital /ID# 249407
state: Greater London
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital /ID# 254707
state: Nottinghamshire
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust /ID# 258141
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust /ID# 246974
city: Manchester
country: United Kingdom
facility: The Christie Hospital /ID# 243422
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: