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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 ID: NCT03539536
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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of South Alabama /ID# 212939, Mobile, Alabama, United States
Mayo Clinic Arizona /ID# 218550, Phoenix, Arizona, United States
Highlands Oncology Group, PA /ID# 215600, Springdale, Arkansas, United States
University of California, Los Angeles /ID# 203219, Los Angeles, California, United States
LA Hematology-Oncology Med Group /ID# 203338, Orange, California, United States
Sutter Medical Center Sacramen /ID# 203299, Sacramento, California, United States
Icri /Id# 227835, Whittier, California, United States
Univ of Colorado Cancer Center /ID# 203212, Aurora, Colorado, United States
Rocky Mountain Cancer Centers /ID# 215789, Lone Tree, Colorado, United States
Advanced Cancer Treatment Center /ID# 239565, Brooksville, Florida, United States
AdventHealth Celebration /ID# 215649, Celebration, Florida, United States
Mayo Clinic /ID# 218488, Jacksonville, Florida, United States
AdventHealth Cancer Institute - Orlando /ID# 239960, Orlando, Florida, United States
Straub Clinic and Hospital /ID# 217905, Honolulu, Hawaii, United States
Northwestern University Feinberg School of Medicine /ID# 203239, Chicago, Illinois, United States
The University of Chicago Medical Center /ID# 203216, Chicago, Illinois, United States
NorthShore University HealthSystem /ID# 215583, Evanston, Illinois, United States
Ingalls Memorial Hosp /ID# 203228, Harvey, Illinois, United States
Joliet Oncology-Hematology Associates, LTD /ID# 203238, Joliet, Illinois, United States
Goshen Center for Cancer Care /ID# 215584, Goshen, Indiana, United States
Univ Kansas Med Ctr /ID# 216804, Kansas City, Kansas, United States
Cancer Center of Kansas /ID# 203235, Wichita, Kansas, United States
Baptist Health /ID# 203283, Lexington, Kentucky, United States
Norton Cancer Institute - St Matthews /ID# 203284, Louisville, Kentucky, United States
Central Maine Medical Center /ID# 216583, Lewiston, Maine, United States
Massachusetts General Hospital /ID# 203215, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 208124, Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 203248, Boston, Massachusetts, United States
Henry Ford Hospital - West Bloomfield /ID# 203220, West Bloomfield, Michigan, United States
Mayo Clinic - Rochester /ID# 215603, Rochester, Minnesota, United States
Hattiesburg Clinic /ID# 227691, Hattiesburg, Mississippi, United States
St. Lukes Cancer Institute /ID# 227697, Kansas City, Missouri, United States
Washington University-School of Medicine /ID# 203217, Saint Louis, Missouri, United States
St. Vincent Frontier Cancer Center /ID# 203292, Billings, Montana, United States
Dartmouth-Hitchcock Medical Center /ID# 203350, Lebanon, New Hampshire, United States
Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 228868, East Brunswick, New Jersey, United States
Atlantic Health System /ID# 203404, Morristown, New Jersey, United States
Capital Health Medical Center /ID# 203403, Pennington, New Jersey, United States
Overlook Medical Center /ID# 211160, Summit, New Jersey, United States
University of New Mexico /ID# 208339, Albuquerque, New Mexico, United States
Gabrail Cancer Center Research /ID# 216056, Canton, Ohio, United States
Univ Hosp Cleveland /ID# 215648, Cleveland, Ohio, United States
Mercy Cancer Center /ID# 231972, Elyria, Ohio, United States
Mercy Research Mercy Clinic Oklahoma Communities, Inc. / OKC /ID# 230154, Oklahoma City, Oklahoma, United States
Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301, Portland, Oregon, United States
Penn State University and Milton S. Hershey Medical Center /ID# 221844, Hershey, Pennsylvania, United States
Allegheny General Hospital /ID# 215585, Pittsburgh, Pennsylvania, United States
Veterans Healthcare System /ID# 215602, Pittsburgh, Pennsylvania, United States
Thompson Cancer Survival Ctr /ID# 228874, Knoxville, Tennessee, United States
Vanderbilt Ingram Cancer Center /ID# 203281, Nashville, Tennessee, United States
Houston Methodist Hospital - Scurlock Tower /ID# 213268, Houston, Texas, United States
Baylor Scott & White Medical Center- Temple /ID# 216578, Temple, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 203224, Fairfax, Virginia, United States
Valley Medical Center /ID# 231459, Renton, Washington, United States
University of Washington /ID# 206056, Seattle, Washington, United States
Medical College of Wisconsin /ID# 210062, Milwaukee, Wisconsin, United States
The Kinghorn Cancer Centre /ID# 207666, Darlinghurst, New South Wales, Australia
Newcastle Private Hospital /ID# 206600, Lambton Heights, New South Wales, Australia
The Tweed Hospital /ID# 206601, Tweed Heads, New South Wales, Australia
Mater Misericordiae Limited /ID# 229639, South Brisbane, Queensland, Australia
St John Of God Subiaco Hospital /ID# 226943, Subiaco, Western Australia, Australia
Universitair Ziekenhuis Antwerpen /ID# 217430, Edegem, Antwerpen, Belgium
Hospital La Louviere Site Jolimont - Helora /ID# 230586, La Louvière, Hainaut, Belgium
Vitaz /Id# 239966, Sint-Niklaas, Oost-Vlaanderen, Belgium
Institut Jules Bordet /ID# 238614, Anderlecht, , Belgium
AZ Maria Middelares /ID# 233474, Gent, , Belgium
Jessa Ziekenhuis /ID# 234047, Hasselt, , Belgium
AZ Groeninge /ID# 217431, Kortrijk, , Belgium
CHU de Liege /ID# 230589, Liege, , Belgium
CHU UCL Namur - Sainte Elisabeth /ID# 234048, Namur, , Belgium
MHAT Dobrich /ID# 230074, Dobrich, , Bulgaria
UMHAT Dr Georgi Stranski EAD /ID# 232024, Pleven, , Bulgaria
Medical Center Nadezhda /ID# 230473, Sofia, , Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD /ID# 232010, Sofia, , Bulgaria
Cross Cancer Institute /ID# 204540, Edmonton, Alberta, Canada
Ottawa Hospital Research Institute /ID# 205579, Ottawa, Ontario, Canada
Princess Margaret Cancer Centre /ID# 204423, Toronto, Ontario, Canada
CISSS de la Monteregie /ID# 211356, Greenfield Park, Quebec, Canada
Anhui Provincial Hospital /ID# 212096, Hefei, Anhui, China
Anhui Chest Hospital /ID# 239048, Hefei, Anhui, China
Anhui Provincial Cancer Hospital /ID# 239058, Hefei, Anhui, China
Beijing Cancer Hospital /ID# 210133, Beijing, Beijing, China
Fujian Provincial Cancer Hospital /ID# 210808, Fuzhou, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University /ID# 232261, Guangzhou, Guangdong, China
Guangxi Medical University Cancer Center /ID# 231560, Nanning, Guangxi, China
Affiliated Hospital of Hebei University /ID# 227262, Baoding, Hebei, China
Harbin Medical University Cancer Hospital /Id# 231573, Harbin, Heilongjiang, China
Henan Cancer Hospital /ID# 210961, Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211119, Wuhan, Hubei, China
The First People's Hospital of Changzhou /ID# 210787, Changzhou, Jiangsu, China
Jilin Cancer Hospital /ID# 210563, Changchun, Jilin, China
Shandong Cancer Hospital /ID# 231577, Jinan, Shandong, China
Shanghai Chest Hospital /ID# 210930, Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center /Id# 210084, Shanghai, Shanghai, China
West China Hospital, Sichuan University /ID# 210022, Chengdu, Sichuan, China
The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 227244, Urumqi, Xinjiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 211154, Hangzhou, Zhejiang, China
Zhejiang Cancer hospital /ID# 210085, Hangzhou, Zhejiang, China
Vseobecna fakultni nemocnice v Praze /ID# 229797, Praha, , Czechia
Multiscan s.r.o. /ID# 241926, Praha, , Czechia
APHM - Hopital Nord /ID# 209854, Marseille, Bouches-du-Rhone, France
Institut Bergonie /ID# 216207, Bordeaux, Gironde, France
CHU Lille - Hôpital Albert Calmette /ID# 205105, Lille, Hauts-de-France, France
Institut Curie /ID# 207046, Paris CEDEX 05, Paris, France
HCL - Hopital Louis Pradel /ID# 216209, Bron, Rhone, France
Centre Leon Berard /ID# 205107, Lyon CEDEX 08, Rhone, France
Centre Hosp Intercommunal de Creteil /ID# 227108, Creteil, Val-de-Marne, France
Institut Gustave Roussy /ID# 205149, Villejuif Cedex, Val-de-Marne, France
CHU Strasbourg - Hopital Civil /ID# 208080, Strasbourg cedex, , France
CHI Toulon-La Seyne sur Mer /ID# 230545, Toulon, , France
Universitatsklinikum Mannheim /ID# 228798, Mannheim, Baden-Wuerttemberg, Germany
Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 232052, Augsburg, Bayern, Germany
Universitaetsklinikum Giessen /ID# 231856, Gießen, Hessen, Germany
Krankenhaus Martha-Maria Halle-Doelau /ID# 205442, Halle (Saale), Sachsen-Anhalt, Germany
Vivantes Klinikum Neukolln /ID# 205928, Berlin, , Germany
Asklepios Fachkliniken Muenchen-Gauting /ID# 207789, Gauting, , Germany
Evangelisches Krankenhaus Hamm /ID# 208043, Hamm, , Germany
Klinikum Kassel /ID# 205443, Kassel, , Germany
Pius-Hospital Oldenburg /ID# 211615, Oldenburg, , Germany
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 205528, Athens, Attiki, Greece
Metropolitan Hospital /ID# 205529, Piraeus, Attiki, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 205530, Heraklion, Kriti, Greece
Bioclinic Thessaloniki /ID# 227261, Thessaloniki, , Greece
Euromedica General Clinic /ID# 227264, Thessaloniki, , Greece
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 204878, Encs, Borsod-Abauj-Zemplen, Hungary
Torokbalinti Tudogyogyintezet /ID# 204883, Torokbalint, Pest, Hungary
Semmelweis Egyetem /ID# 204434, Budapest, , Hungary
Duplicate_Veszprem Megyei Tudogyogyintez /ID# 213950, Farkasgyepu, , Hungary
Matrai Gyogyintezet /ID# 204432, Matrahaza, , Hungary
Cork University Hospital /ID# 205103, Wilton, Cork, Ireland
Mater Misericordiae Univ Hospital /ID# 231466, Dublin 7, Dublin, Ireland
St James Hospital /ID# 205104, Dublin 8, Dublin, Ireland
St Vincent's University Hospital /ID# 205102, Elm Park, Dublin, Ireland
Rambam Health Care Campus /ID# 204866, Haifa, H_efa, Israel
Rabin Medical Center /ID# 215322, Haifa, H_efa, Israel
Soroka University Medical Center /ID# 204898, Be'er Sheva, HaDarom, Israel
Meir Medical Center /ID# 204255, Kfar Saba, HaMerkaz, Israel
The Chaim Sheba Medical Center /ID# 204254, Ramat Gan, Tel-Aviv, Israel
Ospedale San Raffaele IRCCS /ID# 226973, Milan, Milano, Italy
Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 215918, Rome, Roma, Italy
Azienda Ospedaliera San Camillo Forlanini /ID# 205163, Rome, Roma, Italy
A.O.U. San Luigi Gonzaga /ID# 204706, Orbassano, Torino, Italy
L'Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Mos /ID# 204707, Avellino, , Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 216153, Bologna, , Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 205601, Meldola, , Italy
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 231948, Napoli, , Italy
Azienda Ospedaliero-Universitaria di Parma /ID# 204983, Parma, , Italy
IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 227011, Rome, , Italy
Chukyo Hospital /ID# 244755, Nagoya-shi, Aichi, Japan
Aichi Cancer Center Hospital /ID# 207790, Nagoya-shi, Aichi, Japan
Hirosaki University Hospital /ID# 245023, Hirosaki-shi, Aomori, Japan
Chiba University Hospital /ID# 232204, Chiba-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center /ID# 232252, Matsuyama-shi, Ehime, Japan
National Hospital Organization Kyushu Cancer Center /ID# 206061, Fukuoka-shi, Fukuoka, Japan
Kurume University Hospital /ID# 227776, Kurume-shi, Fukuoka, Japan
Chugoku Central Hospital /ID# 245022, Fukuyama-shi, Hiroshima, Japan
Himeji Medical Center /ID# 227777, Himeji-shi, Hyogo, Japan
Kobe Minimally Invasive Cancer Center /ID# 248590, Kobe-shi, Hyogo, Japan
Takarazuka City Hospital /ID# 245185, Takarazuka-shi, Hyogo, Japan
Yokohama Municipal Citizen's Hospital /ID# 248374, Yokohama-shi, Kanagawa, Japan
Kanagawa Cancer Center /ID# 205068, Yokohama-shi, Kanagawa, Japan
Matsusaka Municipal Hospital /ID# 230219, Matsusaka-shi, Mie, Japan
Sendai Kousei Hospital /ID# 216460, Sendai-shi, Miyagi, Japan
Niigata Cancer Center Hospital /ID# 216462, Niigata-shi, Niigata, Japan
Okayama University Hospital /ID# 227851, Okayama-shi, Okayama, Japan
Osaka City General Hospital /ID# 233172, Osaka-shi, Osaka, Japan
Osaka International Cancer Institute /ID# 210735, Osaka-shi, Osaka, Japan
Kinki-Chuo Chest Medical Center /ID# 216461, Sakai-shi, Osaka, Japan
Saitama Cancer Center /ID# 232508, Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center /ID# 205065, Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital /ID# 205066, Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR /ID# 216463, Koto-ku, Tokyo, Japan
Yamaguchi - Ube Medical Center /ID# 227778, Ube-shi, Yamaguchi, Japan
Fujieda Municipal General Hospital /ID# 248589, Fujieda-shi, , Japan
Hiroshima Citizens Hospital /ID# 218087, Hiroshima-shi, , Japan
National Cancer Center /ID# 204241, Goyang, Gyeonggido, Korea, Republic of
Seoul National University Bundang Hospital /ID# 204237, Seongnam, Gyeonggido, Korea, Republic of
The Catholic University of Korea, ST. Vincent's Hospital /ID# 229647, Suwon, Gyeonggido, Korea, Republic of
Pusan National University Yangsan Hospital /ID# 233871, Yangsan-si, Gyeongsangnamdo, Korea, Republic of
Chungbuk National Univ Hosp /ID# 205680, Cheongju, , Korea, Republic of
Inha University Hospital /ID# 234206, Incheon, , Korea, Republic of
Chonnam National University Hwasun Hospital /ID# 206951, Jeonnam, , Korea, Republic of
Asan Medical Center /ID# 204236, Seoul, , Korea, Republic of
Samsung Medical Center /ID# 227083, Seoul, , Korea, Republic of
Antoni van Leeuwenhoek /ID# 216657, Amsterdam, Noord-Holland, Netherlands
Meander Medisch Centrum /ID# 217756, Amersfoort, , Netherlands
Ziekenhuis St. Jansdal /ID# 216658, Harderwijk, , Netherlands
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej /ID# 231476, Lodz, Lodzkie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 230595, Warsaw, Mazowieckie, Poland
Wojewodzki Szpital im. Sw. Ojca Pio /ID# 231960, Przemysl, Podkarpackie, Poland
Med Polonia Sp. z o. o. /ID# 229908, Poznan, Wielkopolskie, Poland
Dom Lekarski S.A. /ID# 231479, Szczecin, Zachodniopomorskie, Poland
VA Caribbean Healthcare System /ID# 206336, San Juan, , Puerto Rico
Puerto Rico Hematology Oncolog /ID# 206337, San Juan, , Puerto Rico
S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 227623, Craiova, Dolj, Romania
Spitalul Municipal Ploiesti /ID# 229097, Ploiesti, Prahova, Romania
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti /ID# 227216, Bucharest, , Romania
Spitalul Clinic Coltea /ID# 227241, Bucharest, , Romania
S.C. Gral Medical Srl /Id# 227215, Bucharest, , Romania
Institutul Oncologic Prof Dr I Chiricuta /ID# 206320, Cluj Napoca, , Romania
Oncomed SRL /ID# 205616, Timisoara, , Romania
Krasnoyarsk Regional Clinical Oncology Dispensary n.a. A.I. Kryzhanovsky /ID# 232065, Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation
LLC Medical Center /ID# 212397, Novosibirsk, Novosibirskaya Oblast, Russian Federation
St. Petersburg scientific center for specialized medical care (oncological) /ID# 206405, Saint Petersburg, Sankt-Peterburg, Russian Federation
Republican Clinical Oncology Dispensary /ID# 206463, Kazan, Tatarstan, Respublika, Russian Federation
Regional Children's Clinical Hospital of Volgograd /ID# 206520, Volgograd, Volgogradskaya Oblast, Russian Federation
Arkhangelsk Clinical Oncology Dispensary /ID# 216418, Arkhangelsk, , Russian Federation
Evimed Clinic /ID# 216473, Chelyabinsk, , Russian Federation
Kostroma region oncology center /ID# 231317, Kostroma, , Russian Federation
Univercity Headache Clynic,LTD /ID# 212080, Moscow, , Russian Federation
VitaMed LLC /ID# 228957, Moscow, , Russian Federation
National Medical Research Radiological Centre /ID# 231263, Obninsk, , Russian Federation
Clinical Oncology Dispensary of Omsk /ID# 239313, Omsk, , Russian Federation
Euromedservice /ID# 206390, Pushkin, , Russian Federation
Newclinic Medical Center /ID# 216262, Pyatigorsk, , Russian Federation
Center of Palliative Medicine De Vita /ID# 212900, St. Petersburg, , Russian Federation
Hospital Clínico Universitario de Santiago-CHUS /ID# 204367, Santiago de Compostela, A Coruna, Spain
Instituto Catalan de Oncologia (ICO) Badalona /ID# 216106, Badalona, Barcelona, Spain
CHU Insular-Materno Infantil /ID# 232362, Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Fundacion Alcorcon /ID# 232361, Alcorcon, Madrid, Spain
Hospital Nuestra Senora de Sonsoles /ID# 232367, Avila, , Spain
Hospital Universitario Dexeus - Grupo Quironsalud /ID# 232368, Barcelona, , Spain
Hospital Universitario Vall d'Hebron /ID# 206997, Barcelona, , Spain
Hospital Universitario Ramon y Cajal /ID# 203922, Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 203913, Madrid, , Spain
Hospital Regional Universitario de Malaga /ID# 216081, Malaga, , Spain
Hospital Universitario Virgen Macarena /ID# 230998, Sevilla, , Spain
Hospital Universitario Virgen del Rocio /ID# 216058, Sevilla, , Spain
Hospital Universitario y Politecnico La Fe /ID# 203862, Valencia, , Spain
Universitätsspital Basel /ID# 230977, Basel, Basel-Stadt, Switzerland
KSW Kantonsspital Winterthur /ID# 231284, Winterthur, Zuerich, Switzerland
Kaohsiung Chang Gung Memorial Hospital /ID# 205423, Kaohsiung City, Kaohsiung, Taiwan
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 205309, Chia-Yi, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 205831, Kaohsiung, , Taiwan
Taipei Medical University Shuang Ho Hospital /ID# 215356, New Taipei City, , Taiwan
Taichung Veterans General Hospital /ID# 205308, Taichung, , Taiwan
National Cheng Kung University Hospital /ID# 205307, Tainan, , Taiwan
National Taiwan University Hospital /ID# 205100, Taipei City, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center /ID# 227336, Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 205424, Taoyuan City, , Taiwan
Adana Sehir Egitim ve Arastirma Hastanesi /ID# 206000, Adana, , Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi /ID# 205243, Ankara, , Turkey
Gazi University Medical Faculty /ID# 239816, Ankara, , Turkey
Akdeniz Universitesi Tip Fakul /ID# 205238, Antalya, , Turkey
Trakya University Medical Facu /ID# 205242, Edirne, Istanbul, , Turkey
Prof. Dr. Suleyman Yalcın Sehir Hastanesi /ID# 215082, Istanbul, , Turkey
Dr. Suat Seren Gogus Has /ID# 215083, Izmir, , Turkey
Barts Health NHS Trust /ID# 239889, London, London, City Of, United Kingdom
Nottingham University Hospitals NHS Trust /ID# 231224, Nottingham, Nottinghamshire, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 205890, Oxford, Oxfordshire, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 206209, Birmingham, , United Kingdom
University College London Hospitals NHS Foundation Trust /ID# 231467, London, , United Kingdom
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR