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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Telisotuzumab vedotin

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • The Kinghorn Cancer Centre /ID# 207666
    • Lambton Heights, New South Wales, Australia, 2305
      • Newcastle Private Hospital /ID# 206600
    • Tweed Heads, New South Wales, Australia, 2485
      • The Tweed Hospital /ID# 206601
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Misericordiae Limited /ID# 229639
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • St John Of God Subiaco Hospital /ID# 226943
• Belgium
  • Anderlecht, Belgium, 1070
    • Institut Jules Bordet /ID# 238614
  • Gent, Belgium, 9000
    • AZ Maria Middelares /ID# 233474
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis /ID# 234047
  • Kortrijk, Belgium, 8500
    • AZ Groeninge /ID# 217431
  • Liege, Belgium, 4000
    • CHU de Liege /ID# 230589
  • Namur, Belgium, 5000
    • CHU UCL Namur - Sainte Elisabeth /ID# 234048
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Universitair Ziekenhuis Antwerpen /ID# 217430
  • Hainaut
    • La Louvière, Hainaut, Belgium, 7100
      • Hospital La Louviere Site Jolimont - Helora /ID# 230586
  • Oost-Vlaanderen
    • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
      • Vitaz /Id# 239966
• Bulgaria
  • Dobrich, Bulgaria, 9300
    • MHAT Dobrich /ID# 230074
  • Pleven, Bulgaria, 5800
    • UMHAT Dr Georgi Stranski EAD /ID# 232024
  • Sofia, Bulgaria, 1330
    • Medical Center Nadezhda /ID# 230473
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda University Hospital EAD /ID# 232010
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute /ID# 204540
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Research Institute /ID# 205579
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre /ID# 204423
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • CISSS de la Monteregie /ID# 211356
• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital /ID# 212096
    • Hefei, Anhui, China, 230022
      • Anhui Chest Hospital /ID# 239048
    • Hefei, Anhui, China, 230031
      • Anhui Provincial Cancer Hospital /ID# 239058
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital /ID# 210133
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Provincial Cancer Hospital /ID# 210808
  • Guangdong
    • Guangzhou, Guangdong, China, 510163
      • The First Affiliated Hospital of Guangzhou Medical University /ID# 232261
  • Guangxi
    • Nanning, Guangxi, China, 530027
      • Guangxi Medical University Cancer Center /ID# 231560
  • Hebei
    • Baoding, Hebei, China, 071000
      • Affiliated Hospital of Hebei University /ID# 227262
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital /Id# 231573
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital /ID# 210961
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211119
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • The First People's Hospital of Changzhou /ID# 210787
  • Jilin
    • Changchun, Jilin, China, 130012
      • Jilin Cancer Hospital /ID# 210563
  • Shandong
    • Jinan, Shandong, China, 251601
      • Shandong Cancer Hospital /ID# 231577
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center /Id# 210084
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital /ID# 210930
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University /ID# 210022
  • Xinjiang
    • Urumqi, Xinjiang, China, 830000
      • The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 227244
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer hospital /ID# 210085
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 211154
• Czechia
  • Praha, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze /ID# 229797
  • Praha, Czechia, 155 00
    • Multiscan s.r.o. /ID# 241926
• France
  • Strasbourg cedex, France, 67091
    • CHU Strasbourg - Hopital Civil /ID# 208080
  • Toulon, France, 83056
    • CHI Toulon-La Seyne sur Mer /ID# 230545
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13015
      • APHM - Hopital Nord /ID# 209854
  • Gironde
    • Bordeaux, Gironde, France, 33000
      • Institut Bergonie /ID# 216207
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59037
      • CHU Lille - Hôpital Albert Calmette /ID# 205105
  • Paris
    • Paris CEDEX 05, Paris, France, 75248
      • Institut Curie /ID# 207046
  • Rhone
    • Bron, Rhone, France, 69500
      • HCL - Hopital Louis Pradel /ID# 216209
    • Lyon CEDEX 08, Rhone, France, 69373
      • Centre Leon Berard /ID# 205107
  • Val-de-Marne
    • Creteil, Val-de-Marne, France, 94000
      • Centre Hosp Intercommunal de Creteil /ID# 227108
    • Villejuif Cedex, Val-de-Marne, France, 94805
      • Institut Gustave Roussy /ID# 205149
• Germany
  • Berlin, Germany, 12351
    • Vivantes Klinikum Neukolln /ID# 205928
  • Gauting, Germany, 82131
    • Asklepios Fachkliniken Muenchen-Gauting /ID# 207789
  • Hamm, Germany, 59063
    • Evangelisches Krankenhaus Hamm /ID# 208043
  • Kassel, Germany, 34125
    • Klinikum Kassel /ID# 205443
  • Oldenburg, Germany, 26121
    • Pius-Hospital Oldenburg /ID# 211615
  • Baden-Wuerttemberg
    • Mannheim, Baden-Wuerttemberg, Germany, 68167
      • Universitatsklinikum Mannheim /ID# 228798
  • Bayern
    • Augsburg, Bayern, Germany, 86150
      • Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 232052
  • Hessen
    • Gießen, Hessen, Germany, 35392
      • Universitaetsklinikum Giessen /ID# 231856
  • Sachsen-Anhalt
    • Halle (Saale), Sachsen-Anhalt, Germany, 06120
      • Krankenhaus Martha-Maria Halle-Doelau /ID# 205442
• Greece
  • Thessaloniki, Greece, 54622
    • Bioclinic Thessaloniki /ID# 227261
  • Thessaloniki, Greece, 54645
    • Euromedica General Clinic /ID# 227264
  • Attiki
    • Athens, Attiki, Greece, 11527
      • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 205528
    • Piraeus, Attiki, Greece, 18547
      • Metropolitan Hospital /ID# 205529
  • Kriti
    • Heraklion, Kriti, Greece, 71500
      • University General Hospital of Heraklion PA.G.N.I /ID# 205530
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 204434
  • Farkasgyepu, Hungary, 8582
    • Duplicate_Veszprem Megyei Tudogyogyintez /ID# 213950
  • Matrahaza, Hungary, 3233
    • Matrai Gyogyintezet /ID# 204432
  • Borsod-Abauj-Zemplen
    • Encs, Borsod-Abauj-Zemplen, Hungary, 3860
      • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 204878
  • Pest
    • Torokbalint, Pest, Hungary, 2045
      • Torokbalinti Tudogyogyintezet /ID# 204883
• Ireland
  • Cork
    • Wilton, Cork, Ireland, T12 E8YV
      • Cork University Hospital /ID# 205103
  • Dublin
    • Dublin 7, Dublin, Ireland, D07 R2WY
      • Mater Misericordiae Univ Hospital /ID# 231466
    • Dublin 8, Dublin, Ireland, D08 NHY1
      • St James Hospital /ID# 205104
    • Elm Park, Dublin, Ireland, D04 T6F4
      • St Vincent's University Hospital /ID# 205102
• Israel
  • H_efa
    • Haifa, H_efa, Israel, 3109601
      • Rambam Health Care Campus /ID# 204866
    • Haifa, H_efa, Israel, 4941492
      • Rabin Medical Center /ID# 215322
  • HaDarom
    • Be'er Sheva, HaDarom, Israel, 8443901
      • Soroka University Medical Center /ID# 204898
  • HaMerkaz
    • Kfar Saba, HaMerkaz, Israel, 4428164
      • Meir Medical Center /ID# 204255
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 204254
• Italy
  • Avellino, Italy, 83100
    • L'Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Mos /ID# 204707
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 216153
  • Meldola, Italy, 47014
    • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 205601
  • Napoli, Italy, 80138
    • AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 231948
  • Parma, Italy, 43126
    • Azienda Ospedaliero-Universitaria di Parma /ID# 204983
  • Rome, Italy, 00144
    • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 227011
  • Milano
    • Milan, Milano, Italy, 20132
      • Ospedale San Raffaele IRCCS /ID# 226973
  • Roma
    • Rome, Roma, Italy, 00128
      • Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 215918
    • Rome, Roma, Italy, 00152
      • Azienda Ospedaliera San Camillo Forlanini /ID# 205163
  • Torino
    • Orbassano, Torino, Italy, 10043
      • A.O.U. San Luigi Gonzaga /ID# 204706
• Japan
  • Fujieda-shi, Japan, 426-8677
    • Fujieda Municipal General Hospital /ID# 248589
  • Hiroshima-shi, Japan, 730-8518
    • Hiroshima Citizens Hospital /ID# 218087
  • Aichi
    • Nagoya-shi, Aichi, Japan, 457-8510
      • Chukyo Hospital /ID# 244755
    • Nagoya-shi, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital /ID# 207790
  • Aomori
    • Hirosaki-shi, Aomori, Japan, 036-8203
      • Hirosaki University Hospital /ID# 245023
  • Chiba
    • Chiba-shi, Chiba, Japan, 260-8677
      • Chiba University Hospital /ID# 232204
  • Ehime
    • Matsuyama-shi, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center /ID# 232252
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 811-1395
      • National Hospital Organization Kyushu Cancer Center /ID# 206061
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Kurume University Hospital /ID# 227776
  • Hiroshima
    • Fukuyama-shi, Hiroshima, Japan, 720-0001
      • Chugoku Central Hospital /ID# 245022
  • Hyogo
    • Himeji-shi, Hyogo, Japan, 670-8520
      • Himeji Medical Center /ID# 227777
    • Kobe-shi, Hyogo, Japan, 650-0046
      • Kobe Minimally Invasive Cancer Center /ID# 248590
    • Takarazuka-shi, Hyogo, Japan, 665-0827
      • Takarazuka City Hospital /ID# 245185
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan, 221-0855
      • Yokohama Municipal Citizen's Hospital /ID# 248374
    • Yokohama-shi, Kanagawa, Japan, 241-8515
      • Kanagawa Cancer Center /ID# 205068
  • Mie
    • Matsusaka-shi, Mie, Japan, 515-8544
      • Matsusaka Municipal Hospital /ID# 230219
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 980-0873
      • Sendai Kousei Hospital /ID# 216460
  • Niigata
    • Niigata-shi, Niigata, Japan, 951-8566
      • Niigata Cancer Center Hospital /ID# 216462
  • Okayama
    • Okayama-shi, Okayama, Japan, 700-8558
      • Okayama University Hospital /ID# 227851
  • Osaka
    • Osaka-shi, Osaka, Japan, 534-0021
      • Osaka City General Hospital /ID# 233172
    • Osaka-shi, Osaka, Japan, 541-8567
      • Osaka International Cancer Institute /ID# 210735
    • Sakai-shi, Osaka, Japan, 591-8555
      • Kinki-Chuo Chest Medical Center /ID# 216461
  • Saitama
    • Kitaadachi-gun, Saitama, Japan, 362-0806
      • Saitama Cancer Center /ID# 232508
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center /ID# 205065
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital /ID# 205066
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital Of JFCR /ID# 216463
  • Yamaguchi
    • Ube-shi, Yamaguchi, Japan, 755-0241
      • Yamaguchi - Ube Medical Center /ID# 227778
• Korea, Republic of
  • Cheongju, Korea, Republic of, 28644
    • Chungbuk National Univ Hosp /ID# 205680
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital /ID# 234206
  • Jeonnam, Korea, Republic of, 58128
    • Chonnam National University Hwasun Hospital /ID# 206951
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center /ID# 204236
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center /ID# 227083
  • Gyeonggido
    • Goyang, Gyeonggido, Korea, Republic of, 10408
      • National Cancer Center /ID# 204241
    • Seongnam, Gyeonggido, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital /ID# 204237
    • Suwon, Gyeonggido, Korea, Republic of, 16247
      • The Catholic University of Korea, ST. Vincent's Hospital /ID# 229647
  • Gyeongsangnamdo
    • Yangsan-si, Gyeongsangnamdo, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital /ID# 233871
• Netherlands
  • Amersfoort, Netherlands, 3813 TZ
    • Meander Medisch Centrum /ID# 217756
  • Harderwijk, Netherlands, 3844 DG
    • Ziekenhuis St. Jansdal /ID# 216658
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1066 CX
      • Antoni van Leeuwenhoek /ID# 216657
• Poland
  • Lodzkie
    • Lodz, Lodzkie, Poland, 90-549
      • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej /ID# 231476
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 230595
  • Podkarpackie
    • Przemysl, Podkarpackie, Poland, 37-700
      • Wojewodzki Szpital im. Sw. Ojca Pio /ID# 231960
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 60-693
      • Med Polonia Sp. z o. o. /ID# 229908
  • Zachodniopomorskie
    • Szczecin, Zachodniopomorskie, Poland, 70-784
      • Dom Lekarski S.A. /ID# 231479
• Puerto Rico
  • San Juan, Puerto Rico, 00921-3201
    • VA Caribbean Healthcare System /ID# 206336
  • San Juan, Puerto Rico, 00959
    • Puerto Rico Hematology Oncolog /ID# 206337
• Romania
  • Bucharest, Romania, 022328
    • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti /ID# 227216
  • Bucharest, Romania, 030171
    • Spitalul Clinic Coltea /ID# 227241
  • Bucharest, Romania, 031422
    • S.C. Gral Medical Srl /Id# 227215
  • Cluj Napoca, Romania, 400015
    • Institutul Oncologic Prof Dr I Chiricuta /ID# 206320
  • Timisoara, Romania, 300239
    • Oncomed SRL /ID# 205616
  • Dolj
    • Craiova, Dolj, Romania, 200347
      • S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 227623
  • Prahova
    • Ploiesti, Prahova, Romania, 100337
      • Spitalul Municipal Ploiesti /ID# 229097
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Arkhangelsk Clinical Oncology Dispensary /ID# 216418
  • Chelyabinsk, Russian Federation, 454048
    • Evimed Clinic /ID# 216473
  • Kostroma, Russian Federation, 156005
    • Kostroma region oncology center /ID# 231317
  • Moscow, Russian Federation, 109028
    • Univercity Headache Clynic,LTD /ID# 212080
  • Moscow, Russian Federation, 121309
    • VitaMed LLC /ID# 228957
  • Obninsk, Russian Federation, 249036
    • National Medical Research Radiological Centre /ID# 231263
  • Omsk, Russian Federation, 644013
    • Clinical Oncology Dispensary of Omsk /ID# 239313
  • Pushkin, Russian Federation, 196603
    • Euromedservice /ID# 206390
  • Pyatigorsk, Russian Federation, 357519
    • Newclinic Medical Center /ID# 216262
  • St. Petersburg, Russian Federation, 197343
    • Center of Palliative Medicine De Vita /ID# 212900
  • Krasnoyarskiy Kray
    • Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation, 660133
      • Krasnoyarsk Regional Clinical Oncology Dispensary n.a. A.I. Kryzhanovsky /ID# 232065
  • Novosibirskaya Oblast
    • Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630099
      • LLC Medical Center /ID# 212397
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758
      • St. Petersburg scientific center for specialized medical care (oncological) /ID# 206405
  • Tatarstan, Respublika
    • Kazan, Tatarstan, Respublika, Russian Federation, 420029
      • Republican Clinical Oncology Dispensary /ID# 206463
  • Volgogradskaya Oblast
    • Volgograd, Volgogradskaya Oblast, Russian Federation, 400138
      • Regional Children's Clinical Hospital of Volgograd /ID# 206520
• Spain
  • Avila, Spain, 05004
    • Hospital Nuestra Senora de Sonsoles /ID# 232367
  • Barcelona, Spain, 08028
    • Hospital Universitario Dexeus - Grupo Quironsalud /ID# 232368
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 206997
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal /ID# 203922
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro /ID# 203913
  • Malaga, Spain, 29011
    • Hospital Regional Universitario de Malaga /ID# 216081
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena /ID# 230998
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 216058
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 203862
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Hospital Clínico Universitario de Santiago-CHUS /ID# 204367
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Instituto Catalan de Oncologia (ICO) Badalona /ID# 216106
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
      • CHU Insular-Materno Infantil /ID# 232362
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon /ID# 232361
• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Universitätsspital Basel /ID# 230977
  • Zuerich
    • Winterthur, Zuerich, Switzerland, 8400
      • KSW Kantonsspital Winterthur /ID# 231284
• Taiwan
  • Chia-Yi, Taiwan, 62247
    • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 205309
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 205831
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University Shuang Ho Hospital /ID# 215356
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital /ID# 205308
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital /ID# 205307
  • Taipei, Taiwan, 112
    • Koo Foundation Sun Yat-Sen Cancer Center /ID# 227336
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital /ID# 205100
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 205424
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 833
      • Kaohsiung Chang Gung Memorial Hospital /ID# 205423
• Turkey
  • Adana, Turkey, 01060
    • Adana Sehir Egitim ve Arastirma Hastanesi /ID# 206000
  • Ankara, Turkey, 06560
    • Gazi University Medical Faculty /ID# 239816
  • Ankara, Turkey, 06200
    • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi /ID# 205243
  • Antalya, Turkey, 07059
    • Akdeniz Universitesi Tip Fakul /ID# 205238
  • Edirne, Istanbul, Turkey, 22030
    • Trakya University Medical Facu /ID# 205242
  • Istanbul, Turkey, 34722
    • Prof. Dr. Suleyman Yalcın Sehir Hastanesi /ID# 215082
  • Izmir, Turkey, 35110
    • Dr. Suat Seren Gogus Has /ID# 215083
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Foundation Trust /ID# 206209
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals NHS Foundation Trust /ID# 231467
  • London, City Of
    • London, London, City Of, United Kingdom, E1 2ES
      • Barts Health NHS Trust /ID# 239889
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Nottingham University Hospitals NHS Trust /ID# 231224
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Oxford University Hospitals NHS Foundation Trust /ID# 205890
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604-3302
      • University of South Alabama /ID# 212939
  • Arizona
    • Phoenix, Arizona, United States, 85054-4504
      • Mayo Clinic Arizona /ID# 218550
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group, PA /ID# 215600
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles /ID# 203219
    • Orange, California, United States, 92868
      • LA Hematology-Oncology Med Group /ID# 203338
    • Sacramento, California, United States, 95816
      • Sutter Medical Center Sacramen /ID# 203299
    • Whittier, California, United States, 90603
      • Icri /Id# 227835
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Univ of Colorado Cancer Center /ID# 203212
    • Lone Tree, Colorado, United States, 80124
      • Rocky Mountain Cancer Centers /ID# 215789
  • Florida
    • Brooksville, Florida, United States, 34613-6072
      • Advanced Cancer Treatment Center /ID# 239565
    • Celebration, Florida, United States, 34747-4970
      • AdventHealth Celebration /ID# 215649
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic /ID# 218488
    • Orlando, Florida, United States, 32804
      • AdventHealth Cancer Institute - Orlando /ID# 239960
  • Hawaii
    • Honolulu, Hawaii, United States, 96813-3097
      • Straub Clinic and Hospital /ID# 217905
  • Illinois
    • Chicago, Illinois, United States, 60611-2927
      • Northwestern University Feinberg School of Medicine /ID# 203239
    • Chicago, Illinois, United States, 60637-1443
      • The University of Chicago Medical Center /ID# 203216
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem /ID# 215583
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hosp /ID# 203228
    • Joliet, Illinois, United States, 60435
      • Joliet Oncology-Hematology Associates, LTD /ID# 203238
  • Indiana
    • Goshen, Indiana, United States, 46526
      • Goshen Center for Cancer Care /ID# 215584
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Univ Kansas Med Ctr /ID# 216804
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas /ID# 203235
  • Kentucky
    • Lexington, Kentucky, United States, 40503-1463
      • Baptist Health /ID# 203283
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute - St Matthews /ID# 203284
  • Maine
    • Lewiston, Maine, United States, 04240
      • Central Maine Medical Center /ID# 216583
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital /ID# 203215
    • Boston, Massachusetts, United States, 02215-5400
      • Beth Israel Deaconess Medical Center /ID# 208124
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute /ID# 203248
  • Michigan
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford Hospital - West Bloomfield /ID# 203220
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 215603
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic /ID# 227691
  • Missouri
    • Kansas City, Missouri, United States, 64111-5905
      • St. Lukes Cancer Institute /ID# 227697
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 203217
  • Montana
    • Billings, Montana, United States, 59102
      • St. Vincent Frontier Cancer Center /ID# 203292
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center /ID# 203350
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 228868
    • Morristown, New Jersey, United States, 07960-6136
      • Atlantic Health System /ID# 203404
    • Pennington, New Jersey, United States, 08534-2520
      • Capital Health Medical Center /ID# 203403
    • Summit, New Jersey, United States, 07901-3533
      • Overlook Medical Center /ID# 211160
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102-4517
      • University of New Mexico /ID# 208339
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research /ID# 216056
    • Cleveland, Ohio, United States, 44106
      • Univ Hosp Cleveland /ID# 215648
    • Elyria, Ohio, United States, 44024
      • Mercy Cancer Center /ID# 231972
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Mercy Research Mercy Clinic Oklahoma Communities, Inc. / OKC /ID# 230154
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-2360
      • Penn State University and Milton S. Hershey Medical Center /ID# 221844
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital /ID# 215585
    • Pittsburgh, Pennsylvania, United States, 15240
      • Veterans Healthcare System /ID# 215602
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Thompson Cancer Survival Ctr /ID# 228874
    • Nashville, Tennessee, United States, 37232-0021
      • Vanderbilt Ingram Cancer Center /ID# 203281
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital - Scurlock Tower /ID# 213268
    • Temple, Texas, United States, 76508-0001
      • Baylor Scott & White Medical Center- Temple /ID# 216578
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists - Fairfax /ID# 203224
  • Washington
    • Renton, Washington, United States, 98055-5738
      • Valley Medical Center /ID# 231459
    • Seattle, Washington, United States, 98109
      • University of Washington /ID# 206056
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Medical College of Wisconsin /ID# 210062

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telisotuzumab vedotin; Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.	Drug: Telisotuzumab vedotin; Intravenous (IV) infusion; Other Names: ABBV-399

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 3 years
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.	Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 3 years
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.	Up to approximately 3 years
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.	Up to approximately 3 years
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.	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Estimated): October 6, 2025
• Study Completion (Estimated): October 6, 2025

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; metastatic; Telisotuzumab vedotin; ABBV-399; Non-small Cell Lung Cancer (NSCLC); c-Met, c-Met overexpression; MET gene amplification; LUMINOSITY
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: M14-239; 2023-507902-15-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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