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

Primary Purpose

Non-small Cell Lung Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Telisotuzumab vedotin
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small Cell Lung Cancer (NSCLC), Cancer, Telisotuzumab vedotin, ABBV-399, c-Met, c-Met overexpression, metastatic, MET gene amplification, LUMINOSITY

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed non-squamous cell non-small cell lung cancer (NSCLC) with known epidermal growth factor receptor (EGFR) status (wild type or mutant; with site documented status). Of note, participants with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met.
  • Has locally advanced or metastatic NSCLC.
  • Has 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 pre-screening period. If archival tissue is c-Met negative, participant can submit fresh biopsy material for reassessment of c-Met expression.

  • 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 gene alteration count as 1 line of therapy for the purposes of this eligibility criterion.
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Exclusion Criteria:

  • Have received prior c-Met-targeted antibody-based therapies.
  • Has adenosquamous histology.
  • Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy).
  • Has a clinically significant condition(s) described in the protocol.
  • Has unresolved clinically significant adverse events >= grade 2 from prior anticancer therapy, except for alopecia or anemia.
  • Had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
  • Has received live vaccine within 30 days of the first dose of telisotuzumab vedotin.
  • History of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis.
  • Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
  • Participants do not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or interstitial lung disease within 3 months of the planned first dose of the study drug.
  • Participants must not have received radiation therapy to the lung <6 months prior to the first dose of telisotuzumab vedotin.

Sites / Locations

  • University of South Alabama /ID# 212939
  • Mayo Clinic Arizona /ID# 218550
  • Highlands Oncology Group, PA /ID# 215600
  • University of California, Los Angeles /ID# 203219
  • LA Hematology-Oncology Med Group /ID# 203338
  • Sutter Medical Center Sacramen /ID# 203299
  • Icri /Id# 227835
  • Univ of Colorado Cancer Center /ID# 203212
  • Rocky Mountain Cancer Centers /ID# 215789
  • Advanced Cancer Treatment Center /ID# 239565
  • AdventHealth Celebration /ID# 215649
  • Mayo Clinic /ID# 218488
  • AdventHealth Cancer Institute - Orlando /ID# 239960
  • Straub Clinic and Hospital /ID# 217905
  • Northwestern University Feinberg School of Medicine /ID# 203239
  • The University of Chicago Medical Center /ID# 203216
  • NorthShore University HealthSystem /ID# 215583
  • Ingalls Memorial Hosp /ID# 203228
  • Joliet Oncology-Hematology Associates, LTD /ID# 203238
  • Goshen Center for Cancer Care /ID# 215584
  • Univ Kansas Med Ctr /ID# 216804
  • Cancer Center of Kansas /ID# 203235
  • Baptist Health /ID# 203283
  • Norton Cancer Institute - St Matthews /ID# 203284
  • Central Maine Medical Center /ID# 216583
  • Massachusetts General Hospital /ID# 203215
  • Beth Israel Deaconess Medical Center /ID# 208124
  • Dana-Farber Cancer Institute /ID# 203248
  • Henry Ford Hospital - West Bloomfield /ID# 203220
  • Mayo Clinic - Rochester /ID# 215603
  • Hattiesburg Clinic /ID# 227691
  • St. Lukes Cancer Institute /ID# 227697
  • Washington University-School of Medicine /ID# 203217
  • St. Vincent Frontier Cancer Center /ID# 203292
  • Dartmouth-Hitchcock Medical Center /ID# 203350
  • Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 228868
  • Atlantic Health System /ID# 203404
  • Capital Health Medical Center /ID# 203403
  • Overlook Medical Center /ID# 211160
  • University of New Mexico /ID# 208339
  • Gabrail Cancer Center Research /ID# 216056
  • Univ Hosp Cleveland /ID# 215648
  • Mercy Cancer Center /ID# 231972
  • Mercy Research Mercy Clinic Oklahoma Communities, Inc. / OKC OK /ID# 230154
  • Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301
  • Penn State University and Milton S. Hershey Medical Center /ID# 221844
  • Allegheny General Hospital /ID# 215585
  • Veterans Healthcare System /ID# 215602
  • Thompson Cancer Survival Ctr /ID# 228874
  • Vanderbilt Ingram Cancer Center /ID# 203281
  • Houston Methodist Hospital - Scurlock Tower /ID# 213268
  • Baylor Scott & White Medical Center- Temple /ID# 216578
  • Virginia Cancer Specialists - Fairfax /ID# 203224
  • Valley Medical Center /ID# 231459
  • University of Washington /ID# 206056
  • Medical College of Wisconsin /ID# 210062
  • The Kinghorn Cancer Centre /ID# 207666
  • Newcastle Private Hospital /ID# 206600
  • The Tweed Hospital /ID# 206601
  • Mater Misericordiae Limited /ID# 229639
  • St John Of God Subiaco Hospital /ID# 226943
  • Universitair Ziekenhuis Antwerpen /ID# 217430
  • Institut Jules Bordet /ID# 238614
  • AZ Maria Middelares /ID# 233474
  • Jessa Ziekenhuis /ID# 234047
  • AZ Groeninge /ID# 217431
  • Pôle Hospitalier Jolimont /ID# 230586
  • CHU de Liege /ID# 230589
  • CHU UCL Namur - Sainte Elisabeth /ID# 234048
  • Vitaz /Id# 239966
  • MHAT Dobrich /ID# 230074
  • UMHAT Dr Georgi Stranski EAD /ID# 232024
  • Medical Center Nadezhda /ID# 230473
  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 232010
  • Cross Cancer Institute /ID# 204540
  • Ottawa Hospital Research Institute /ID# 205579
  • Princess Margaret Cancer Centre /ID# 204423
  • CISSS de la Monteregie /ID# 211356
  • Anhui Provincial Hospital /ID# 212096
  • Anhui Chest Hospital /ID# 239048
  • Anhui Provincial Cancer Hospital /ID# 239058
  • Beijing Cancer Hospital /ID# 210133
  • Fujian Provincial Cancer Hospital /ID# 210808
  • The First Affiliated Hospital of Guangzhou Medical University /ID# 232261
  • Guangxi Medical University Cancer Center /ID# 231560
  • Affiliated Hospital of Hebei University /ID# 227262
  • Harbin Medical University Cancer Hospital /ID# 231573
  • Henan Cancer Hospital /ID# 210961
  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211119
  • The First People's Hospital of Changzhou /ID# 210787
  • Jilin Cancer Hospital /ID# 210563
  • Shandong Cancer Hospital /ID# 231577
  • Fudan University Shanghai Cancer Center /Id# 210084
  • West China Hospital, Sichuan University /ID# 210022
  • The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 227244
  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 211154
  • Zhejiang Cancer hospital /ID# 210085
  • Shanghai Chest Hospital /ID# 210930
  • Vseobecna fakultni nemocnice v Praze /ID# 229797
  • Multiscan s.r.o. /ID# 241926
  • APHM - Hopital Nord /ID# 209854
  • Institut Bergonie /ID# 216207
  • CHU Lille - Hôpital Albert Calmette /ID# 205105
  • Institut Curie /ID# 207046
  • Centre Leon Berard /ID# 205107
  • Centre Hosp Intercommunal de Creteil /ID# 227108
  • Institut Gustave Roussy /ID# 205149
  • HCL - Hopital Louis Pradel /ID# 216209
  • CHU Strasbourg - Hopital Civil /ID# 208080
  • CHI Toulon-La Seyne sur Mer /ID# 230545
  • Universitatsklinikum Mannheim /ID# 228798
  • Haematologisch-Onkologische Praxis im Zentrum Augsburg /ID# 232052
  • Universitaetsklinikum Giessen /ID# 231856
  • Krankenhaus Martha-Maria Halle-Doelau /ID# 205442
  • Vivantes Klinikum Neukoelln /ID# 205928
  • Asklepios Fachkliniken Muenchen-Gauting /ID# 207789
  • Evangelisches Krankenhaus Hamm /ID# 208043
  • Klinikum Kassel /ID# 205443
  • Pius-Hospital Oldenburg /ID# 211615
  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 205528
  • Metropolitan Hospital /ID# 205529
  • University General Hospital of Heraklion PA.G.N.I /ID# 205530
  • Bioclinic Thessaloniki /ID# 227261
  • Euromedica General Clinic /ID# 227264
  • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 204878
  • Torokbalinti Tudogyogyintezet /ID# 204883
  • Semmelweis Egyetem /ID# 204434
  • Duplicate_Veszprem Megyei Tudogyogyintez /ID# 213950
  • Matrai Gyogyintezet /ID# 204432
  • Cork University Hospital /ID# 205103
  • Mater Misericordiae Univ Hospital /ID# 231466
  • St James Hospital /ID# 205104
  • St Vincent's University Hospital /ID# 205102
  • Soroka University Medical Center /ID# 204898
  • The Chaim Sheba Medical Center /ID# 204254
  • Rambam Health Care Campus /ID# 204866
  • Meir Medical Center /ID# 204255
  • Rabin Medical Center /ID# 215322
  • Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 215918
  • Azienda Ospedaliera San Camillo Forlanini /ID# 205163
  • Ospedale San Raffaele IRCCS /ID# 226973
  • A.O.U. San Luigi Gonzaga /ID# 204706
  • L'Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Mos /ID# 204707
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 216153
  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 205601
  • AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 231948
  • Azienda Ospedaliero-Universitaria di Parma /ID# 204983
  • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 227011
  • Chukyo Hospital /ID# 244755
  • Aichi Cancer Center Hospital /ID# 207790
  • Hirosaki University Hospital /ID# 245023
  • Chiba University Hospital /ID# 232204
  • National Hospital Organization Shikoku Cancer Center /ID# 232252
  • National Hospital Organization Kyushu Cancer Center /ID# 206061
  • Kurume University Hospital /ID# 227776
  • Chugoku Central Hospital /ID# 245022
  • Himeji Medical Center /ID# 227777
  • Kobe Minimally Invasive Cancer Center /ID# 248590
  • Takarazuka City Hospital /ID# 245185
  • Yokohama Municipal Citizen's Hospital /ID# 248374
  • Kanagawa Cancer Center /ID# 205068
  • Matsusaka Municipal Hospital /ID# 230219
  • Sendai Kousei Hospital /ID# 216460
  • Niigata Cancer Center Hospital /ID# 216462
  • Okayama University Hospital /ID# 227851
  • Osaka City General Hospital /ID# 233172
  • Osaka International Cancer Institute /ID# 210735
  • Kinki-Chuo Chest Medical Center /ID# 216461
  • Saitama Cancer Center /ID# 232508
  • Shizuoka Cancer Center /ID# 205065
  • National Cancer Center Hospital /ID# 205066
  • The Cancer Institute Hospital Of JFCR /ID# 216463
  • Yamaguchi - Ube Medical Center /ID# 227778
  • Fujieda Municipal General Hospital /ID# 248589
  • Hiroshima Citizens Hospital /ID# 218087
  • National Cancer Center /ID# 204241
  • Seoul National University Bundang Hospital /ID# 204237
  • The Catholic University of Korea, ST. Vincent's Hospital /ID# 229647
  • Pusan National University Yangsan Hospital /ID# 233871
  • Chungbuk National Univ Hosp /ID# 205680
  • Inha University Hospital /ID# 234206
  • Chonnam National University Hwasun Hospital /ID# 206951
  • Asan Medical Center /ID# 204236
  • Samsung Medical Center /ID# 227083
  • Antoni van Leeuwenhoek /ID# 216657
  • Meander Medisch Centrum /ID# 217756
  • Ziekenhuis St. Jansdal /ID# 216658
  • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej /ID# 231476
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 230595
  • Wojewodzki Szpital im. Sw. Ojca Pio /ID# 231960
  • Med Polonia Sp. z o. o. /ID# 229908
  • Dom Lekarski S.A. /ID# 231479
  • VA Caribbean Healthcare System /ID# 206336
  • Puerto Rico Hematology Oncolog /ID# 206337
  • S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 227623
  • Spitalul Municipal Ploiesti /ID# 229097
  • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti /ID# 227216
  • Spitalul Clinic Coltea /ID# 227241
  • S.C. Gral Medical Srl /Id# 227215
  • Institutul Oncologic Prof Dr I Chiricuta /ID# 206320
  • Oncomed SRL /ID# 205616
  • LLC Medical Center /ID# 212397
  • St. Petersburg scientific center for specialized medical care (oncological) /ID# 206405
  • Republican Clinical Oncology Dispensary /ID# 206463
  • Regional Children's Clinical Hospital of Volgograd /ID# 206520
  • Arkhangelsk Clinical Oncology Dispensary /ID# 216418
  • Evimed Clinic /ID# 216473
  • Kostroma region oncology center /ID# 231317
  • Krasnoyarsk Regional Clinical Oncology Dispensary n.a. A.I. Kryzhanovsky /ID# 232065
  • Univercity Headache Clynic,LTD /ID# 212080
  • VitaMed LLC /ID# 228957
  • National Medical Research Radiological Centre /ID# 231263
  • Clinical Oncology Dispensary of Omsk /ID# 239313
  • Euromedservice /ID# 206390
  • Newclinic Medical Center /ID# 216262
  • Center of Palliative Medicine De Vita /ID# 212900
  • Hospital Clínico Universitario de Santiago-CHUS /ID# 204367
  • Instituto Catalan de Oncologia (ICO) Badalona /ID# 216106
  • CHU Insular-Materno Infantil /ID# 232362
  • Hospital Universitario Fundacion Alcorcon /ID# 232361
  • Hospital Nuestra Senora de Sonsoles /ID# 232367
  • Hospital Universitario Dexeus - Grupo Quironsalud /ID# 232368
  • Hospital Universitario Vall d'Hebron /ID# 206997
  • Hospital Universitario Ramon y Cajal /ID# 203922
  • Hospital Universitario HM Sanchinarro /ID# 203913
  • Hospital Regional Universitario de Malaga /ID# 216081
  • Hospital Universitario Virgen Macarena /ID# 230998
  • Hospital Universitario Virgen del Rocio /ID# 216058
  • Hospital Universitario y Politecnico La Fe /ID# 203862
  • Universitätsspital Basel /ID# 230977
  • KSW Kantonsspital Winterthur /ID# 231284
  • Kaohsiung Chang Gung Memorial Hospital /ID# 205423
  • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 205309
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 205831
  • Taipei Medical University Shuang Ho Hospital /ID# 215356
  • Taichung Veterans General Hospital /ID# 205308
  • National Cheng Kung University Hospital /ID# 205307
  • National Taiwan University Hospital /ID# 205100
  • Koo Foundation Sun Yat-Sen Cancer Center /ID# 227336
  • Linkou Chang Gung Memorial Hospital /ID# 205424
  • Adana Sehir Egitim ve Arastirma Hastanesi /ID# 206000
  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 205243
  • Gazi University Medical Faculty /ID# 239816
  • Akdeniz Universitesi Tip Fakul /ID# 205238
  • Trakya University Medical Facu /ID# 205242
  • Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 215082
  • Dr. Suat Seren Gogus Has /ID# 215083
  • Barts Health NHS Trust /ID# 239889
  • Nottingham University Hospitals NHS Trust /ID# 231224
  • Oxford University Hospitals NHS Foundation Trust /ID# 205890
  • University Hospitals Birmingham NHS Foundation Trust /ID# 206209
  • University College London Hospitals NHS Foundation Trust /ID# 231467

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telisotuzumab vedotin

Arm Description

Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR) (Stage 1 and Stage 2)
ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Number of Participants with Adverse Events (Alternate dose cohort)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Secondary Outcome Measures

Duration of Response (DoR) (Stage 1 and Stage 2)
DoR is defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression determined by an independent central review or death from any cause for the responders.
Disease Control Rate (DCR) (Stage 1 and Stage 2)
DCR is defined as the percentage of participants with best overall response of confirmed CR, confirmed PR, or stable disease (SD) for at least 12 weeks following enrollment, based on RECIST, version 1.1.
Progression-Free Survival (PFS) (Stage 1 and Stage 2)
PFS is defined as the time from the participant's first dose of study drug until the first occurrence of radiographic progression determined by an independent central review or death from any cause.
Overall Survival (OS) (Stage 1 and Stage 2)
OS is defined as the time from the participant's first dose of study drug until death from any cause.

Full Information

First Posted
May 17, 2018
Last Updated
July 12, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03539536
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
September 24, 2025 (Anticipated)
Study Completion Date
September 24, 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telisotuzumab vedotin
Arm Type
Experimental
Arm Description
Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.
Intervention Type
Drug
Intervention Name(s)
Telisotuzumab vedotin
Other Intervention Name(s)
ABBV-399
Intervention Description
Intravenous (IV) infusion
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) (Stage 1 and Stage 2)
Description
ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Time Frame
Up to approximately 3 years
Title
Number of Participants with Adverse Events (Alternate dose cohort)
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time Frame
Up to approximately 3 years
Secondary Outcome Measure Information:
Title
Duration of Response (DoR) (Stage 1 and Stage 2)
Description
DoR is defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression determined by an independent central review or death from any cause for the responders.
Time Frame
Up to approximately 3 years
Title
Disease Control Rate (DCR) (Stage 1 and Stage 2)
Description
DCR is defined as the percentage of participants with best overall response of confirmed CR, confirmed PR, or stable disease (SD) for at least 12 weeks following enrollment, based on RECIST, version 1.1.
Time Frame
Up to approximately 3 years
Title
Progression-Free Survival (PFS) (Stage 1 and Stage 2)
Description
PFS is defined as the time from the participant's first dose of study drug until the first occurrence of radiographic progression determined by an independent central review or death from any cause.
Time Frame
Up to approximately 3 years
Title
Overall Survival (OS) (Stage 1 and Stage 2)
Description
OS is defined as the time from the participant's first dose of study drug until death from any cause.
Time Frame
Up to approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama /ID# 212939
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604-3302
Country
United States
Facility Name
Mayo Clinic Arizona /ID# 218550
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054-4504
Country
United States
Facility Name
Highlands Oncology Group, PA /ID# 215600
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
University of California, Los Angeles /ID# 203219
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
LA Hematology-Oncology Med Group /ID# 203338
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sutter Medical Center Sacramen /ID# 203299
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Icri /Id# 227835
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Univ of Colorado Cancer Center /ID# 203212
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Cancer Centers /ID# 215789
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Advanced Cancer Treatment Center /ID# 239565
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613-6072
Country
United States
Facility Name
AdventHealth Celebration /ID# 215649
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747-4970
Country
United States
Facility Name
Mayo Clinic /ID# 218488
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
AdventHealth Cancer Institute - Orlando /ID# 239960
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Straub Clinic and Hospital /ID# 217905
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813-3097
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine /ID# 203239
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
The University of Chicago Medical Center /ID# 203216
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
NorthShore University HealthSystem /ID# 215583
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ingalls Memorial Hosp /ID# 203228
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, LTD /ID# 203238
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Goshen Center for Cancer Care /ID# 215584
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Univ Kansas Med Ctr /ID# 216804
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Cancer Center of Kansas /ID# 203235
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Baptist Health /ID# 203283
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503-1463
Country
United States
Facility Name
Norton Cancer Institute - St Matthews /ID# 203284
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Central Maine Medical Center /ID# 216583
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
Massachusetts General Hospital /ID# 203215
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 208124
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
Dana-Farber Cancer Institute /ID# 203248
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Hospital - West Bloomfield /ID# 203220
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 215603
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Hattiesburg Clinic /ID# 227691
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
St. Lukes Cancer Institute /ID# 227697
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111-5905
Country
United States
Facility Name
Washington University-School of Medicine /ID# 203217
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Vincent Frontier Cancer Center /ID# 203292
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 203350
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 228868
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
Atlantic Health System /ID# 203404
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960-6136
Country
United States
Facility Name
Capital Health Medical Center /ID# 203403
City
Pennington
State/Province
New Jersey
ZIP/Postal Code
08534-2520
Country
United States
Facility Name
Overlook Medical Center /ID# 211160
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901-3533
Country
United States
Facility Name
University of New Mexico /ID# 208339
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102-4517
Country
United States
Facility Name
Gabrail Cancer Center Research /ID# 216056
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Univ Hosp Cleveland /ID# 215648
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Mercy Cancer Center /ID# 231972
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44024
Country
United States
Facility Name
Mercy Research Mercy Clinic Oklahoma Communities, Inc. / OKC OK /ID# 230154
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Penn State University and Milton S. Hershey Medical Center /ID# 221844
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-2360
Country
United States
Facility Name
Allegheny General Hospital /ID# 215585
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Veterans Healthcare System /ID# 215602
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Thompson Cancer Survival Ctr /ID# 228874
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Vanderbilt Ingram Cancer Center /ID# 203281
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0021
Country
United States
Facility Name
Houston Methodist Hospital - Scurlock Tower /ID# 213268
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Scott & White Medical Center- Temple /ID# 216578
City
Temple
State/Province
Texas
ZIP/Postal Code
76508-0001
Country
United States
Facility Name
Virginia Cancer Specialists - Fairfax /ID# 203224
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Valley Medical Center /ID# 231459
City
Renton
State/Province
Washington
ZIP/Postal Code
98055-5738
Country
United States
Facility Name
University of Washington /ID# 206056
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Medical College of Wisconsin /ID# 210062
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Facility Name
The Kinghorn Cancer Centre /ID# 207666
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Newcastle Private Hospital /ID# 206600
City
Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
The Tweed Hospital /ID# 206601
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
Mater Misericordiae Limited /ID# 229639
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
St John Of God Subiaco Hospital /ID# 226943
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Universitair Ziekenhuis Antwerpen /ID# 217430
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Institut Jules Bordet /ID# 238614
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Facility Name
AZ Maria Middelares /ID# 233474
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Jessa Ziekenhuis /ID# 234047
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
AZ Groeninge /ID# 217431
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Pôle Hospitalier Jolimont /ID# 230586
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
CHU de Liege /ID# 230589
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU UCL Namur - Sainte Elisabeth /ID# 234048
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Vitaz /Id# 239966
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
MHAT Dobrich /ID# 230074
City
Dobrich
ZIP/Postal Code
9300
Country
Bulgaria
Facility Name
UMHAT Dr Georgi Stranski EAD /ID# 232024
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Medical Center Nadezhda /ID# 230473
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
Acibadem City Clinic Tokuda University Hospital EAD /ID# 232010
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Cross Cancer Institute /ID# 204540
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Ottawa Hospital Research Institute /ID# 205579
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Cancer Centre /ID# 204423
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CISSS de la Monteregie /ID# 211356
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Anhui Provincial Hospital /ID# 212096
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Anhui Chest Hospital /ID# 239048
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Anhui Provincial Cancer Hospital /ID# 239058
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Facility Name
Beijing Cancer Hospital /ID# 210133
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Fujian Provincial Cancer Hospital /ID# 210808
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University /ID# 232261
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510163
Country
China
Facility Name
Guangxi Medical University Cancer Center /ID# 231560
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530027
Country
China
Facility Name
Affiliated Hospital of Hebei University /ID# 227262
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Facility Name
Harbin Medical University Cancer Hospital /ID# 231573
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital /ID# 210961
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211119
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
The First People's Hospital of Changzhou /ID# 210787
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Jilin Cancer Hospital /ID# 210563
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Shandong Cancer Hospital /ID# 231577
City
Jinan
State/Province
Shandong
ZIP/Postal Code
251601
Country
China
Facility Name
Fudan University Shanghai Cancer Center /Id# 210084
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
West China Hospital, Sichuan University /ID# 210022
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 227244
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 211154
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Zhejiang Cancer hospital /ID# 210085
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Shanghai Chest Hospital /ID# 210930
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Vseobecna fakultni nemocnice v Praze /ID# 229797
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Multiscan s.r.o. /ID# 241926
City
Praha
ZIP/Postal Code
155 00
Country
Czechia
Facility Name
APHM - Hopital Nord /ID# 209854
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13015
Country
France
Facility Name
Institut Bergonie /ID# 216207
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33000
Country
France
Facility Name
CHU Lille - Hôpital Albert Calmette /ID# 205105
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Facility Name
Institut Curie /ID# 207046
City
Paris CEDEX 05
State/Province
Ile-de-France
ZIP/Postal Code
75248
Country
France
Facility Name
Centre Leon Berard /ID# 205107
City
Lyon CEDEX 08
State/Province
Rhone
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Hosp Intercommunal de Creteil /ID# 227108
City
Creteil
State/Province
Val-de-Marne
ZIP/Postal Code
94000
Country
France
Facility Name
Institut Gustave Roussy /ID# 205149
City
Villejuif Cedex
State/Province
Val-de-Marne
ZIP/Postal Code
94805
Country
France
Facility Name
HCL - Hopital Louis Pradel /ID# 216209
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
CHU Strasbourg - Hopital Civil /ID# 208080
City
Strasbourg cedex
ZIP/Postal Code
67091
Country
France
Facility Name
CHI Toulon-La Seyne sur Mer /ID# 230545
City
Toulon
ZIP/Postal Code
83056
Country
France
Facility Name
Universitatsklinikum Mannheim /ID# 228798
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Haematologisch-Onkologische Praxis im Zentrum Augsburg /ID# 232052
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86150
Country
Germany
Facility Name
Universitaetsklinikum Giessen /ID# 231856
City
Gießen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Krankenhaus Martha-Maria Halle-Doelau /ID# 205442
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
Vivantes Klinikum Neukoelln /ID# 205928
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Asklepios Fachkliniken Muenchen-Gauting /ID# 207789
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Evangelisches Krankenhaus Hamm /ID# 208043
City
Hamm
ZIP/Postal Code
59063
Country
Germany
Facility Name
Klinikum Kassel /ID# 205443
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Pius-Hospital Oldenburg /ID# 211615
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 205528
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
Metropolitan Hospital /ID# 205529
City
Piraeus
State/Province
Attiki
ZIP/Postal Code
18547
Country
Greece
Facility Name
University General Hospital of Heraklion PA.G.N.I /ID# 205530
City
Heraklion
State/Province
Kriti
ZIP/Postal Code
71500
Country
Greece
Facility Name
Bioclinic Thessaloniki /ID# 227261
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Facility Name
Euromedica General Clinic /ID# 227264
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 204878
City
Encs
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3860
Country
Hungary
Facility Name
Torokbalinti Tudogyogyintezet /ID# 204883
City
Torokbalint
State/Province
Pest
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Semmelweis Egyetem /ID# 204434
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Duplicate_Veszprem Megyei Tudogyogyintez /ID# 213950
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Matrai Gyogyintezet /ID# 204432
City
Matrahaza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Cork University Hospital /ID# 205103
City
Wilton
State/Province
Cork
ZIP/Postal Code
T12 E8YV
Country
Ireland
Facility Name
Mater Misericordiae Univ Hospital /ID# 231466
City
Dublin 7
State/Province
Dublin
ZIP/Postal Code
D07 R2WY
Country
Ireland
Facility Name
St James Hospital /ID# 205104
City
Dublin 8
State/Province
Dublin
ZIP/Postal Code
D08 NHY1
Country
Ireland
Facility Name
St Vincent's University Hospital /ID# 205102
City
Elm Park
State/Province
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
Soroka University Medical Center /ID# 204898
City
Be'er Sheva
State/Province
HaDarom
ZIP/Postal Code
8443901
Country
Israel
Facility Name
The Chaim Sheba Medical Center /ID# 204254
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 204866
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Meir Medical Center /ID# 204255
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center /ID# 215322
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 215918
City
Rome
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini /ID# 205163
City
Rome
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Ospedale San Raffaele IRCCS /ID# 226973
City
Milan
State/Province
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
A.O.U. San Luigi Gonzaga /ID# 204706
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
L'Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Mos /ID# 204707
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 216153
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 205601
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 231948
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Parma /ID# 204983
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 227011
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Chukyo Hospital /ID# 244755
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
457-8510
Country
Japan
Facility Name
Aichi Cancer Center Hospital /ID# 207790
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Hirosaki University Hospital /ID# 245023
City
Hirosaki-shi
State/Province
Aomori
ZIP/Postal Code
036-8203
Country
Japan
Facility Name
Chiba University Hospital /ID# 232204
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center /ID# 232252
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center /ID# 206061
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kurume University Hospital /ID# 227776
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Chugoku Central Hospital /ID# 245022
City
Fukuyama-shi
State/Province
Hiroshima
ZIP/Postal Code
720-0001
Country
Japan
Facility Name
Himeji Medical Center /ID# 227777
City
Himeji-shi
State/Province
Hyogo
ZIP/Postal Code
670-8520
Country
Japan
Facility Name
Kobe Minimally Invasive Cancer Center /ID# 248590
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0046
Country
Japan
Facility Name
Takarazuka City Hospital /ID# 245185
City
Takarazuka-shi
State/Province
Hyogo
ZIP/Postal Code
665-0827
Country
Japan
Facility Name
Yokohama Municipal Citizen's Hospital /ID# 248374
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
221-0855
Country
Japan
Facility Name
Kanagawa Cancer Center /ID# 205068
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Matsusaka Municipal Hospital /ID# 230219
City
Matsusaka-shi
State/Province
Mie
ZIP/Postal Code
515-8544
Country
Japan
Facility Name
Sendai Kousei Hospital /ID# 216460
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Niigata Cancer Center Hospital /ID# 216462
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Okayama University Hospital /ID# 227851
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka City General Hospital /ID# 233172
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Osaka International Cancer Institute /ID# 210735
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Kinki-Chuo Chest Medical Center /ID# 216461
City
Sakai-shi
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Saitama Cancer Center /ID# 232508
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center /ID# 205065
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Cancer Center Hospital /ID# 205066
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Cancer Institute Hospital Of JFCR /ID# 216463
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Yamaguchi - Ube Medical Center /ID# 227778
City
Ube-shi
State/Province
Yamaguchi
ZIP/Postal Code
755-0241
Country
Japan
Facility Name
Fujieda Municipal General Hospital /ID# 248589
City
Fujieda-shi
ZIP/Postal Code
426-8677
Country
Japan
Facility Name
Hiroshima Citizens Hospital /ID# 218087
City
Hiroshima-shi
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
National Cancer Center /ID# 204241
City
Goyang
State/Province
Gyeonggido
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital /ID# 204237
City
Seongnam
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, ST. Vincent's Hospital /ID# 229647
City
Suwon
State/Province
Gyeonggido
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital /ID# 233871
City
Yangsan-si
State/Province
Gyeongsangnamdo
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Chungbuk National Univ Hosp /ID# 205680
City
Cheongju
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Inha University Hospital /ID# 234206
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital /ID# 206951
City
Jeonnam
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 204236
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 227083
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Antoni van Leeuwenhoek /ID# 216657
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Meander Medisch Centrum /ID# 217756
City
Amersfoort
ZIP/Postal Code
3813 TZ
Country
Netherlands
Facility Name
Ziekenhuis St. Jansdal /ID# 216658
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej /ID# 231476
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-549
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 230595
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Wojewodzki Szpital im. Sw. Ojca Pio /ID# 231960
City
Przemysl
State/Province
Podkarpackie
ZIP/Postal Code
37-700
Country
Poland
Facility Name
Med Polonia Sp. z o. o. /ID# 229908
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Dom Lekarski S.A. /ID# 231479
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-784
Country
Poland
Facility Name
VA Caribbean Healthcare System /ID# 206336
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico
Facility Name
Puerto Rico Hematology Oncolog /ID# 206337
City
San Juan
ZIP/Postal Code
00959
Country
Puerto Rico
Facility Name
S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 227623
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200347
Country
Romania
Facility Name
Spitalul Municipal Ploiesti /ID# 229097
City
Ploiesti
State/Province
Prahova
ZIP/Postal Code
100337
Country
Romania
Facility Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti /ID# 227216
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Spitalul Clinic Coltea /ID# 227241
City
Bucharest
ZIP/Postal Code
030171
Country
Romania
Facility Name
S.C. Gral Medical Srl /Id# 227215
City
Bucharest
ZIP/Postal Code
031422
Country
Romania
Facility Name
Institutul Oncologic Prof Dr I Chiricuta /ID# 206320
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Oncomed SRL /ID# 205616
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Facility Name
LLC Medical Center /ID# 212397
City
Novosibirsk
State/Province
Novosibirskaya Oblast
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
St. Petersburg scientific center for specialized medical care (oncological) /ID# 206405
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary /ID# 206463
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Regional Children's Clinical Hospital of Volgograd /ID# 206520
City
Volgograd
State/Province
Volgogradskaya Oblast
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Arkhangelsk Clinical Oncology Dispensary /ID# 216418
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Evimed Clinic /ID# 216473
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
Kostroma region oncology center /ID# 231317
City
Kostroma
ZIP/Postal Code
156005
Country
Russian Federation
Facility Name
Krasnoyarsk Regional Clinical Oncology Dispensary n.a. A.I. Kryzhanovsky /ID# 232065
City
Krasnoyarsk
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Univercity Headache Clynic,LTD /ID# 212080
City
Moscow
ZIP/Postal Code
109028
Country
Russian Federation
Facility Name
VitaMed LLC /ID# 228957
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
National Medical Research Radiological Centre /ID# 231263
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Clinical Oncology Dispensary of Omsk /ID# 239313
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Euromedservice /ID# 206390
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Newclinic Medical Center /ID# 216262
City
Pyatigorsk
ZIP/Postal Code
357519
Country
Russian Federation
Facility Name
Center of Palliative Medicine De Vita /ID# 212900
City
St. Petersburg
ZIP/Postal Code
197343
Country
Russian Federation
Facility Name
Hospital Clínico Universitario de Santiago-CHUS /ID# 204367
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Instituto Catalan de Oncologia (ICO) Badalona /ID# 216106
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
CHU Insular-Materno Infantil /ID# 232362
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital Universitario Fundacion Alcorcon /ID# 232361
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Nuestra Senora de Sonsoles /ID# 232367
City
Avila
ZIP/Postal Code
05004
Country
Spain
Facility Name
Hospital Universitario Dexeus - Grupo Quironsalud /ID# 232368
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron /ID# 206997
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal /ID# 203922
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro /ID# 203913
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga /ID# 216081
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena /ID# 230998
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio /ID# 216058
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 203862
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Universitätsspital Basel /ID# 230977
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
KSW Kantonsspital Winterthur /ID# 231284
City
Winterthur
State/Province
Zuerich
ZIP/Postal Code
8400
Country
Switzerland
Facility Name
Kaohsiung Chang Gung Memorial Hospital /ID# 205423
City
Kaohsiung City
State/Province
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 205309
City
Chia-Yi
ZIP/Postal Code
62247
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 205831
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Taipei Medical University Shuang Ho Hospital /ID# 215356
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
Taichung Veterans General Hospital /ID# 205308
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital /ID# 205307
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 205100
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center /ID# 227336
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital /ID# 205424
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Adana Sehir Egitim ve Arastirma Hastanesi /ID# 206000
City
Adana
ZIP/Postal Code
01060
Country
Turkey
Facility Name
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 205243
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Gazi University Medical Faculty /ID# 239816
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Facility Name
Akdeniz Universitesi Tip Fakul /ID# 205238
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Trakya University Medical Facu /ID# 205242
City
Edirne, Istanbul
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 215082
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Dr. Suat Seren Gogus Has /ID# 215083
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
Facility Name
Barts Health NHS Trust /ID# 239889
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust /ID# 231224
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust /ID# 205890
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust /ID# 206209
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust /ID# 231467
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

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

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