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
  • Ghent, Belgium, 9000
    • AZ Maria Middelares /ID# 233474
  • Kortrijk, Belgium, 8500
    • AZ Groeninge /ID# 217431
  • Liège, Belgium, 4000
    • Duplicate_CHU de Liege /ID# 230589
  • Namur, Belgium, 5000
    • UCL Namur University Hospital, Site 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
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Jessa Ziekenhuis /ID# 234047
  • 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
      • Duplicate_Cross Cancer Institute /ID# 204540
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Research Institute /ID# 205579
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network_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, 230031
      • Anhui Provincial Cancer Hospital /ID# 239058
    • Hefei, Anhui, China, 230032
      • Anhui Medical University - Anhui Chest Hospital /ID# 239048
  • Beijing Municipality
    • Beijing, Beijing Municipality, 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, 530021
      • Affiliated Cancer Hospital of Guangxi Medical University /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 Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Shanghai Chest Hospital /ID# 210930
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Cancer Hospital /ID# 210084
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University /ID# 210022
  • Xinjiang
    • Ürümqi, 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
  • Prague, Czechia, 155 00
    • Multiscan s.r.o. /ID# 241926
  • Praha 17
    • Prague, Praha 17, Czechia, 128 08
      • Duplicate_Vseobecna fakultni nemocnice v Praze /ID# 229797
• France
  • Strasbourg, France, 67091
    • CHU Strasbourg - Hopital Civil /ID# 208080
  • 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, Paris, France, 75248
      • Institut Curie /ID# 207046
  • Rhone
    • Bron, Rhone, France, 69500
      • Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 216209
    • Lyon, Rhone, France, 69373
      • Centre Leon Berard /ID# 205107
  • Val-de-Marne
    • Créteil, Val-de-Marne, France, 94000
      • Centre Hosp Intercommunal de Creteil /ID# 227108
    • Villejuif, Val-de-Marne, France, 94805
      • Institut Gustave Roussy /ID# 205149
  • Var
    • Toulon, Var, France, 83056
      • CHI Toulon-La Seyne sur Mer /ID# 230545
• 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
  • Baden-Wurttemberg
    • Mannheim, Baden-Wurttemberg, Germany, 68167
      • Universitatsklinikum Mannheim /ID# 228798
  • Bavaria
    • Augsburg, Bavaria, Germany, 86150
      • Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 232052
  • Hesse
    • Giessen, Hesse, Germany, 35392
      • Universitaetsklinikum Giessen /ID# 231856
    • Kassel, Hesse, Germany, 34125
      • Klinikum Kassel /ID# 205443
  • Lower Saxony
    • Oldenburg, Lower Saxony, Germany, 26121
      • Pius-Hospital Oldenburg /ID# 211615
  • Saxony-Anhalt
    • Halle, Saxony-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
  • Attica
    • Athens, Attica, Greece, 11527
      • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 205528
    • Piraeus, Attica, Greece, 18547
      • Metropolitan Hospital /ID# 205529
  • Crete
    • Heraklion, Crete, Greece, 71500
      • University General Hospital of Heraklion PA.G.N.I /ID# 205530
• Hungary
  • Budapest, Hungary, 1085
    • Duplicate_Semmelweis Egyetem /ID# 204434
  • Farkasgyepű, Hungary, 8582
    • Duplicate_Veszprem Megyei Tudogyogyintez /ID# 213950
  • Mátraháza, Hungary, 3233
    • Matrai Gyogyintezet /ID# 204432
  • Borsod-Abauj Zemplen county
    • Encs, Borsod-Abauj Zemplen county, Hungary, 3860
      • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 204878
  • Pest County
    • Törökbálint, Pest County, Hungary, 2045
      • Torokbalinti Tudogyogyintezet /ID# 204883
• Ireland
  • Cork
    • Wilton, Cork, Ireland, T12 E8YV
      • Cork University Hospital /ID# 205103
  • Dublin
    • Dublin, Dublin, Ireland, D07 R2WY
      • Mater Misericordiae Univ Hospital /ID# 231466
    • Dublin, Dublin, Ireland, D08 NHY1
      • St James Hospital /ID# 205104
    • Elm Park, Dublin, Ireland, D04 T6F4
      • St Vincents University Hospital /ID# 205102
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 204866
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 215322
  • Central District
    • Kfar Saba, Central District, Israel, 4428164
      • Meir Medical Center /ID# 204255
  • Southern District
    • Beersheba, Southern District, Israel, 8443901
      • Soroka University Medical Center /ID# 204898
  • 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
  • Parma, Italy, 43126
    • Azienda Ospedaliero-Universitaria di Parma /ID# 204983
  • Roma, Italy, 00128
    • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 215918
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 216153
  • Forlì-Cesena
    • Meldola, Forlì-Cesena, Italy, 47014
      • Duplicate_Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 205601
  • Milano
    • Milan, Milano, Italy, 20132
      • IRCCS Ospedale San Raffaele /ID# 226973
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Azienda Ospedaliera Universitaria Federico II /ID# 231948
  • Roma
    • Rome, Roma, Italy, 00144
      • Duplicate_IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Reg /ID# 227011
    • Rome, Roma, Italy, 00149
      • Azienda Ospedaliera San Camillo Forlanini /ID# 205163
  • Torino
    • Orbassano, Torino, Italy, 10043
      • Duplicate_A.O.U. San Luigi Gonzaga /ID# 204706
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 457-8510
      • Chukyo Hospital /ID# 244755
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center Hospital /ID# 207790
  • Aomori
    • Hirosaki-shi, Aomori, Japan, 036-8203
      • Hirosaki University Hospital /ID# 245023
  • Chiba
    • Chiba, Chiba, Japan, 260-8677
      • Duplicate_Chiba University Hospital /ID# 232204
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Duplicate_National Hospital Organization Shikoku Cancer Center /ID# 232252
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 811-1395
      • Duplicate_National Hospital Organization Kyushu Cancer Center /ID# 206061
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Kurume University Hospital /ID# 227776
  • Hiroshima
    • Fukuyama, Hiroshima, Japan, 720-0001
      • Chugoku Central Hospital /ID# 245022
    • Hiroshima, Hiroshima, Japan, 730-8518
      • Hiroshima Citizens Hospital /ID# 218087
  • Hyōgo
    • Himeji-shi, Hyōgo, Japan, 670-8520
      • Himeji Medical Center /ID# 227777
    • Kobe, Hyōgo, Japan, 650-0046
      • Kobe Minimally Invasive Cancer Center /ID# 248590
    • Takarazuka-shi, Hyōgo, Japan, 665-0827
      • Takarazuka City Hospital /ID# 245185
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 221-0855
      • Yokohama Municipal Citizen's Hospital /ID# 248374
    • Yokohama, Kanagawa, Japan, 241-8515
      • Duplicate_Kanagawa Cancer Center /ID# 205068
  • Mie-ken
    • Matsusaka-shi, Mie-ken, Japan, 515-8544
      • Matsusaka Municipal Hospital /ID# 230219
  • Miyagi
    • Sendai, Miyagi, Japan, 980-0873
      • Sendai Kousei Hospital /ID# 216460
  • Niigata
    • Niigata, Niigata, Japan, 951-8566
      • Niigata Cancer Center Hospital /ID# 216462
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 700-8558
      • Okayama University Hospital /ID# 227851
  • Osaka
    • Osaka, Osaka, Japan, 534-0021
      • Osaka City General Hospital /ID# 233172
    • Osaka, Osaka, Japan, 5418567
      • Osaka International Cancer Institute /ID# 210735
    • Sakai-shi, Osaka, Japan, 591-8555
      • NHO Kinki Chuo Chest Medical Center /ID# 216461
  • Saitama
    • Kitaadachi-gun, Saitama, Japan, 362-0806
      • Duplicate_Saitama Cancer Center /ID# 232508
  • Shizuoka
    • Fujieda-shi, Shizuoka, Japan, 426-8677
      • Fujieda Municipal General Hospital /ID# 248589
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Duplicate_Duplicate_Duplicate_Shizuoka Cancer Center /ID# 205065
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital /ID# 205066
    • Koto-ku, Tokyo, Japan, 135-8550
      • Duplicate_The Cancer Institute Hospital Of JFCR /ID# 216463
  • Yamaguchi
    • Ube-shi, Yamaguchi, Japan, 755-0241
      • Yamaguchi - Ube Medical Center /ID# 227778
• Netherlands
  • Gelderland
    • Harderwijk, Gelderland, Netherlands, 3844 DG
      • Ziekenhuis St. Jansdal /ID# 216658
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1066 CX
      • Antoni van Leeuwenhoek /ID# 216657
  • Utrecht
    • Amersfoort, Utrecht, Netherlands, 3813 TZ
      • Meander Medisch Centrum /ID# 217756
• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-693
      • Med Polonia Sp. z o. o. /ID# 229908
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 230595
  • Podkarpackie Voivodeship
    • Przemyśl, Podkarpackie Voivodeship, Poland, 37-700
      • Wojewodzki Szpital im. Sw. Ojca Pio /ID# 231960
  • West Pomeranian Voivodeship
    • Szczecin, West Pomeranian Voivodeship, Poland, 70-784
      • Dom Lekarski S.A. /ID# 231479
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 90-549
      • Duplicate_Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej /ID# 231476
• 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
    • Cluj-Napoca, Cluj, Romania, 400015
      • Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca /ID# 206320
  • Dolj
    • Craiova, Dolj, Romania, 200347
      • S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 227623
  • Prahova
    • Ploieşti, Prahova, Romania, 100337
      • Spitalul Municipal Ploiesti /ID# 229097
  • Timiș County
    • Timișoara, Timiș County, Romania, 300239
      • Oncomed SRL /ID# 205616
• Russia
  • Arkhangelsk, Russia, 163045
    • Arkhangelsk Clinical Oncology Dispensary /ID# 216418
  • Chelyabinsk, Russia, 454048
    • Evimed Clinic /ID# 216473
  • Kostroma, Russia, 156005
    • Kostroma region oncology center /ID# 231317
  • Moscow, Russia, 109028
    • Univercity Headache Clynic,LTD /ID# 212080
  • Moscow, Russia, 121309
    • VitaMed LLC /ID# 228957
  • Obninsk, Russia, 249036
    • National Medical Research Radiological Centre /ID# 231263
  • Pushkin, Russia, 196603
    • Euromedservice /ID# 206390
  • Saint Petersburg, Russia, 197343
    • Center of Palliative Medicine De Vita /ID# 212900
  • Krasnoyarsk Krai
    • Krasnoyarsk, Krasnoyarsk Krai, Russia, 660133
      • Krasnoyarsk Regional Clinical Oncology Dispensary n.a. A.I. Kryzhanovsky /ID# 232065
  • Novosibirsk Oblast
    • Novosibirsk, Novosibirsk Oblast, Russia, 630099
      • LLC Medical Center /ID# 212397
  • Omsk Oblast
    • Omsk, Omsk Oblast, Russia, 644013
      • Clinical Oncology Dispensary of Omsk /ID# 239313
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 197758
      • St. Petersburg scientific center for specialized medical care (oncological) /ID# 206405
  • Stavropol Kray
    • Pyatigorsk, Stavropol Kray, Russia, 357519
      • Newclinic Medical Center /ID# 216262
  • Tatarstan, Respublika
    • Kazan', Tatarstan, Respublika, Russia, 420029
      • Republican Clinical Oncology Dispensary /ID# 206463
  • Volgograd Oblast
    • Volgograd, Volgograd Oblast, Russia, 400138
      • Regional Children's Clinical Hospital of Volgograd /ID# 206520
• South Korea
  • Gyeonggido
    • Goyang-si, Gyeonggido, South Korea, 10408
      • National Cancer Center /ID# 204241
    • Seongnam, Gyeonggido, South Korea, 13620
      • Duplicate_Seoul National University Bundang Hospital /ID# 204237
    • Suwon, Gyeonggido, South Korea, 16247
      • The Catholic University Of Korea St. Vincent's Hospital /ID# 229647
  • Gyeongsangnam-do
    • Yangsan, Gyeongsangnam-do, South Korea, 50612
      • Pusan National University Yangsan Hospital /ID# 233871
  • Incheon Gwang Yeogsi
    • Incheon, Incheon Gwang Yeogsi, South Korea, 21565
      • Inha University Hospital /ID# 234206
  • Jeonranamdo
    • Hwasun-gun, Jeonranamdo, South Korea, 58128
      • Chonnam National University Hwasun Hospital /ID# 206951
  • North Chungcheong
    • Cheongju-si, North Chungcheong, South Korea, 28644
      • Duplicate_Chungbuk National Univ Hosp /ID# 205680
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 05505
      • Asan Medical Center /ID# 204236
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Samsung Medical Center /ID# 227083
• Spain
  • Barcelona, Spain, 08028
    • Hospital Universitario Dexeus - Grupo Quironsalud /ID# 232368
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall de Hebron /ID# 206997
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal /ID# 203922
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro /ID# 203913
  • Málaga, Spain, 29011
    • Hospital Regional Universitario de Malaga /ID# 216081
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena /ID# 230998
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 216058
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 203862
  • Ávila, Spain, 05004
    • Hospital Nuestra Senora de Sonsoles /ID# 232367
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Duplicate_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
    • Alcorcón, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon /ID# 232361
• Switzerland
  • Canton of Basel-City
    • Basel Town, Canton of Basel-City, Switzerland, 4031
      • University Hospital Basel /ID# 230977
  • Canton of Zurich
    • Winterthur, Canton of Zurich, Switzerland, 8400
      • KSW Kantonsspital Winterthur /ID# 231284
• Taiwan
  • Chiayi City, Taiwan, 62247
    • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 205309
  • Kaohsiung City, 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 City, Taiwan, 704
    • National Cheng Kung University Hospital /ID# 205307
  • Taipei, Taiwan, 112
    • Koo Foundation Sun Yat-Sen Cancer Center /ID# 227336
  • Taoyuan, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 205424
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 833
      • Duplicate_Kaohsiung Chang Gung Memorial Hospital /ID# 205423
  • Taipei
    • Taipei City, Taipei, Taiwan, 100
      • National Taiwan University Hospital /ID# 205100
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01060
    • Adana Sehir Egitim ve Arastirma Hastanesi /ID# 206000
  • Ankara, Turkey (Türkiye), 06200
    • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 205243
  • Ankara, Turkey (Türkiye), 06560
    • Gazi University Medical Faculty /ID# 239816
  • Antalya, Turkey (Türkiye), 07059
    • Akdeniz Universitesi Tip Fakul /ID# 205238
  • Edirne, Istanbul, Turkey (Türkiye), 22030
    • Trakya University Medical Facu /ID# 205242
  • Istanbul, Turkey (Türkiye), 34722
    • Prof. Dr. Suleyman Yalcın Sehir Hastanesi /ID# 215082
  • Izmir, Turkey (Türkiye), 35110
    • Dr. Suat Seren Gogus Has /ID# 215083
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Foundation Trust /ID# 206209
  • Greater London
    • London, Greater London, United Kingdom, E1 2ES
      • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 239889
    • London, Greater London, United Kingdom, NW1 2BU
      • University College London Hospital /ID# 231467
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Nottingham City Hospital /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
      • Duplicate_Rocky Mountain Cancer Centers - Lone Tree /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
      • Duplicate_Mayo Clinic /ID# 218488
    • Orlando, Florida, United States, 32804
      • Duplicate_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
      • Duplicate_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
      • Duplicate_Baptist Health /ID# 203283
    • Louisville, Kentucky, United States, 40207
      • Duplicate_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
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital /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
    • St Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 203217
  • Montana
    • Billings, Montana, United States, 59102
      • Duplicate_Intermountain Health - St Vincent Regional Hospital - Cancer Centers o /ID# 203292
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Duplicate_Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /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
      • Duplicate_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, 15240
      • Veterans Healthcare System /ID# 215602
    • Pittsburgh, Pennsylvania, United States, 15212
      • Duplicate_Allegheny General Hospital /ID# 215585
  • 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 /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
      • Wisconsin Medical Center /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

Publications and helpful links

General Publications

• Camidge DR, Bar J, Horinouchi H, Goldman J, Moiseenko F, Filippova E, Cicin I, Ciuleanu T, Daaboul N, Liu C, Bradbury P, Moskovitz M, Katgi N, Tomasini P, Zer A, Girard N, Cuppens K, Han JY, Wu SY, Baijal S, Mansfield AS, Kuo CH, Nishino K, Lee SH, Planchard D, Baik C, Li M, Ansell P, Xia S, Bolotin E, Looman J, Ratajczak C, Lu S. Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein-Overexpressing Advanced Nonsquamous EGFR-Wildtype Non-Small Cell Lung Cancer in the Phase II LUMINOSITY Trial. J Clin Oncol. 2024 Sep 1;42(25):3000-3011. doi: 10.1200/JCO.24.00720. Epub 2024 Jun 6.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

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): November 5, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

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: Pathologic Processes; Neoplasms by Site; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathological Conditions, Signs and Symptoms; Neoplasms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; telisotuzumab vedotin
• 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 clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about 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

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