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
2 other identifiers
interventional
270
26 countries
252
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Oct 2018
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
252 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2018
CompletedFirst Posted
Study publicly available on registry
May 29, 2018
CompletedStudy Start
First participant enrolled
October 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
November 5, 2025
November 1, 2025
7.7 years
May 17, 2018
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Duration of Response (DoR) (Stage 1 and Stage 2)
Up to approximately 3 years
Disease Control Rate (DCR) (Stage 1 and Stage 2)
Up to approximately 3 years
Progression-Free Survival (PFS) (Stage 1 and Stage 2)
Up to approximately 3 years
Overall Survival (OS) (Stage 1 and Stage 2)
Up to approximately 3 years
Study Arms (1)
Telisotuzumab vedotin
EXPERIMENTALTelisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (252)
University of South Alabama /ID# 212939
Mobile, Alabama, 36604-3302, United States
Mayo Clinic Arizona /ID# 218550
Phoenix, Arizona, 85054-4504, United States
Highlands Oncology Group, PA /ID# 215600
Springdale, Arkansas, 72762, United States
University of California, Los Angeles /ID# 203219
Los Angeles, California, 90095, United States
LA Hematology-Oncology Med Group /ID# 203338
Orange, California, 92868, United States
Sutter Medical Center Sacramen /ID# 203299
Sacramento, California, 95816, United States
Icri /Id# 227835
Whittier, California, 90603, United States
Univ of Colorado Cancer Center /ID# 203212
Aurora, Colorado, 80045, United States
Duplicate_Rocky Mountain Cancer Centers - Lone Tree /ID# 215789
Lone Tree, Colorado, 80124, United States
Advanced Cancer Treatment Center /ID# 239565
Brooksville, Florida, 34613-6072, United States
AdventHealth Celebration /ID# 215649
Celebration, Florida, 34747-4970, United States
Duplicate_Mayo Clinic /ID# 218488
Jacksonville, Florida, 32224, United States
Duplicate_AdventHealth Cancer Institute - Orlando /ID# 239960
Orlando, Florida, 32804, United States
Straub Clinic and Hospital /ID# 217905
Honolulu, Hawaii, 96813-3097, United States
Northwestern University Feinberg School of Medicine /ID# 203239
Chicago, Illinois, 60611-2927, United States
The University of Chicago Medical Center /ID# 203216
Chicago, Illinois, 60637-1443, United States
Duplicate_NorthShore University HealthSystem /ID# 215583
Evanston, Illinois, 60201, United States
Ingalls Memorial Hosp /ID# 203228
Harvey, Illinois, 60426, United States
Joliet Oncology-Hematology Associates, LTD /ID# 203238
Joliet, Illinois, 60435, United States
Goshen Center for Cancer Care /ID# 215584
Goshen, Indiana, 46526, United States
Univ Kansas Med Ctr /ID# 216804
Kansas City, Kansas, 66160, United States
Cancer Center of Kansas /ID# 203235
Wichita, Kansas, 67214, United States
Duplicate_Baptist Health /ID# 203283
Lexington, Kentucky, 40503-1463, United States
Duplicate_Norton Cancer Institute - St Matthews /ID# 203284
Louisville, Kentucky, 40207, United States
Central Maine Medical Center /ID# 216583
Lewiston, Maine, 04240, United States
Massachusetts General Hospital /ID# 203215
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center /ID# 208124
Boston, Massachusetts, 02215-5400, United States
Dana-Farber Cancer Institute /ID# 203248
Boston, Massachusetts, 02215, United States
Henry Ford Hospital /ID# 203220
Detroit, Michigan, 48202, United States
Mayo Clinic - Rochester /ID# 215603
Rochester, Minnesota, 55905-0001, United States
Hattiesburg Clinic /ID# 227691
Hattiesburg, Mississippi, 39401, United States
St. Lukes Cancer Institute /ID# 227697
Kansas City, Missouri, 64111-5905, United States
Washington University-School of Medicine /ID# 203217
St Louis, Missouri, 63110, United States
Duplicate_Intermountain Health - St Vincent Regional Hospital - Cancer Centers o /ID# 203292
Billings, Montana, 59102, United States
Duplicate_Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 203350
Lebanon, New Hampshire, 03756, United States
Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 228868
East Brunswick, New Jersey, 08816, United States
Atlantic Health System /ID# 203404
Morristown, New Jersey, 07960-6136, United States
Capital Health Medical Center /ID# 203403
Pennington, New Jersey, 08534-2520, United States
Overlook Medical Center /ID# 211160
Summit, New Jersey, 07901-3533, United States
University of New Mexico /ID# 208339
Albuquerque, New Mexico, 87102-4517, United States
Duplicate_Gabrail Cancer Center Research /ID# 216056
Canton, Ohio, 44718, United States
Univ Hosp Cleveland /ID# 215648
Cleveland, Ohio, 44106, United States
Mercy Cancer Center /ID# 231972
Elyria, Ohio, 44024, United States
Mercy Research Mercy Clinic Oklahoma Communities, Inc. / OKC /ID# 230154
Oklahoma City, Oklahoma, 73120, United States
Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301
Portland, Oregon, 97225, United States
Penn State University and Milton S. Hershey Medical Center /ID# 221844
Hershey, Pennsylvania, 17033-2360, United States
Duplicate_Allegheny General Hospital /ID# 215585
Pittsburgh, Pennsylvania, 15212, United States
Veterans Healthcare System /ID# 215602
Pittsburgh, Pennsylvania, 15240, United States
Thompson Cancer Survival Ctr /ID# 228874
Knoxville, Tennessee, 37916, United States
Vanderbilt Ingram Cancer Center /ID# 203281
Nashville, Tennessee, 37232-0021, United States
Houston Methodist Hospital /ID# 213268
Houston, Texas, 77030, United States
Baylor Scott & White Medical Center- Temple /ID# 216578
Temple, Texas, 76508-0001, United States
Virginia Cancer Specialists - Fairfax /ID# 203224
Fairfax, Virginia, 22031, United States
Valley Medical Center /ID# 231459
Renton, Washington, 98055-5738, United States
University of Washington /ID# 206056
Seattle, Washington, 98109, United States
Wisconsin Medical Center /ID# 210062
Milwaukee, Wisconsin, 53226, United States
The Kinghorn Cancer Centre /ID# 207666
Darlinghurst, New South Wales, 2010, Australia
Newcastle Private Hospital /ID# 206600
Lambton Heights, New South Wales, 2305, Australia
The Tweed Hospital /ID# 206601
Tweed Heads, New South Wales, 2485, Australia
Mater Misericordiae Limited /ID# 229639
South Brisbane, Queensland, 4101, Australia
St John Of God Subiaco Hospital /ID# 226943
Subiaco, Western Australia, 6008, Australia
Universitair Ziekenhuis Antwerpen /ID# 217430
Edegem, Antwerpen, 2650, Belgium
Hospital La Louviere Site Jolimont - Helora /ID# 230586
La Louvière, Hainaut, 7100, Belgium
Jessa Ziekenhuis /ID# 234047
Hasselt, Limburg, 3500, Belgium
Vitaz /Id# 239966
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
Institut Jules Bordet /ID# 238614
Anderlecht, 1070, Belgium
AZ Maria Middelares /ID# 233474
Ghent, 9000, Belgium
AZ Groeninge /ID# 217431
Kortrijk, 8500, Belgium
Duplicate_CHU de Liege /ID# 230589
Liège, 4000, Belgium
UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 234048
Namur, 5000, Belgium
MHAT Dobrich /ID# 230074
Dobrich, 9300, Bulgaria
UMHAT Dr Georgi Stranski EAD /ID# 232024
Pleven, 5800, Bulgaria
Medical Center Nadezhda /ID# 230473
Sofia, 1330, Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD /ID# 232010
Sofia, 1407, Bulgaria
Duplicate_Cross Cancer Institute /ID# 204540
Edmonton, Alberta, T6G 1Z2, Canada
Ottawa Hospital Research Institute /ID# 205579
Ottawa, Ontario, K1H 8L6, Canada
University Health Network_Princess Margaret Cancer Centre /ID# 204423
Toronto, Ontario, M5G 2M9, Canada
CISSS de la Monteregie /ID# 211356
Greenfield Park, Quebec, J4V 2H1, Canada
Anhui Provincial Hospital /ID# 212096
Hefei, Anhui, 230001, China
Anhui Provincial Cancer Hospital /ID# 239058
Hefei, Anhui, 230031, China
Anhui Medical University - Anhui Chest Hospital /ID# 239048
Hefei, Anhui, 230032, China
Beijing Cancer Hospital /ID# 210133
Beijing, Beijing Municipality, 100142, China
Fujian Provincial Cancer Hospital /ID# 210808
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital Of Guangzhou Medical University /ID# 232261
Guangzhou, Guangdong, 510163, China
Affiliated Cancer Hospital of Guangxi Medical University /ID# 231560
Nanning, Guangxi, 530021, China
Affiliated Hospital of Hebei University /ID# 227262
Baoding, Hebei, 071000, China
Harbin Medical University Cancer Hospital /Id# 231573
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital /ID# 210961
Zhengzhou, Henan, 450008, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211119
Wuhan, Hubei, 430022, China
The First People's Hospital of Changzhou /ID# 210787
Changzhou, Jiangsu, 213003, China
Jilin Cancer Hospital /ID# 210563
Changchun, Jilin, 130012, China
Shandong Cancer Hospital /ID# 231577
Jinan, Shandong, 251601, China
Shanghai Chest Hospital /ID# 210930
Shanghai, Shanghai Municipality, 200030, China
Fudan University Cancer Hospital /ID# 210084
Shanghai, Shanghai Municipality, 200032, China
West China Hospital, Sichuan University /ID# 210022
Chengdu, Sichuan, 610041, China
The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 227244
Ürümqi, Xinjiang, 830000, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 211154
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer hospital /ID# 210085
Hangzhou, Zhejiang, 310022, China
Duplicate_Vseobecna fakultni nemocnice v Praze /ID# 229797
Prague, Praha 17, 128 08, Czechia
Multiscan s.r.o. /ID# 241926
Prague, 155 00, Czechia
APHM - Hopital Nord /ID# 209854
Marseille, Bouches-du-Rhone, 13015, France
Institut Bergonie /ID# 216207
Bordeaux, Gironde, 33000, France
CHU Lille - Hôpital Albert Calmette /ID# 205105
Lille, Hauts-de-France, 59037, France
Institut Curie /ID# 207046
Paris, Paris, 75248, France
Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 216209
Bron, Rhone, 69500, France
Centre Leon Berard /ID# 205107
Lyon, Rhone, 69373, France
Centre Hosp Intercommunal de Creteil /ID# 227108
Créteil, Val-de-Marne, 94000, France
Institut Gustave Roussy /ID# 205149
Villejuif, Val-de-Marne, 94805, France
CHI Toulon-La Seyne sur Mer /ID# 230545
Toulon, Var, 83056, France
CHU Strasbourg - Hopital Civil /ID# 208080
Strasbourg, 67091, France
Universitatsklinikum Mannheim /ID# 228798
Mannheim, Baden-Wurttemberg, 68167, Germany
Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 232052
Augsburg, Bavaria, 86150, Germany
Universitaetsklinikum Giessen /ID# 231856
Giessen, Hesse, 35392, Germany
Klinikum Kassel /ID# 205443
Kassel, Hesse, 34125, Germany
Pius-Hospital Oldenburg /ID# 211615
Oldenburg, Lower Saxony, 26121, Germany
Krankenhaus Martha-Maria Halle-Doelau /ID# 205442
Halle, Saxony-Anhalt, 06120, Germany
Vivantes Klinikum Neukolln /ID# 205928
Berlin, 12351, Germany
Asklepios Fachkliniken Muenchen-Gauting /ID# 207789
Gauting, 82131, Germany
Evangelisches Krankenhaus Hamm /ID# 208043
Hamm, 59063, Germany
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 205528
Athens, Attica, 11527, Greece
Metropolitan Hospital /ID# 205529
Piraeus, Attica, 18547, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 205530
Heraklion, Crete, 71500, Greece
Bioclinic Thessaloniki /ID# 227261
Thessaloniki, 54622, Greece
Euromedica General Clinic /ID# 227264
Thessaloniki, 54645, Greece
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 204878
Encs, Borsod-Abauj Zemplen county, 3860, Hungary
Torokbalinti Tudogyogyintezet /ID# 204883
Törökbálint, Pest County, 2045, Hungary
Duplicate_Semmelweis Egyetem /ID# 204434
Budapest, 1085, Hungary
Duplicate_Veszprem Megyei Tudogyogyintez /ID# 213950
Farkasgyepű, 8582, Hungary
Matrai Gyogyintezet /ID# 204432
Mátraháza, 3233, Hungary
Cork University Hospital /ID# 205103
Wilton, Cork, T12 E8YV, Ireland
Mater Misericordiae Univ Hospital /ID# 231466
Dublin, Dublin, D07 R2WY, Ireland
St James Hospital /ID# 205104
Dublin, Dublin, D08 NHY1, Ireland
St Vincents University Hospital /ID# 205102
Elm Park, Dublin, D04 T6F4, Ireland
Meir Medical Center /ID# 204255
Kfar Saba, Central District, 4428164, Israel
Soroka University Medical Center /ID# 204898
Beersheba, Southern District, 8443901, Israel
The Chaim Sheba Medical Center /ID# 204254
Ramat Gan, Tel Aviv, 5265601, Israel
Rambam Health Care Campus /ID# 204866
Haifa, 3109601, Israel
Rabin Medical Center /ID# 215322
Petah Tikva, 4941492, Israel
Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 216153
Bologna, Emilia-Romagna, 40138, Italy
Duplicate_Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 205601
Meldola, Forlì-Cesena, 47014, Italy
IRCCS Ospedale San Raffaele /ID# 226973
Milan, Milano, 20132, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 231948
Naples, Napoli, 80131, Italy
Duplicate_IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Reg /ID# 227011
Rome, Roma, 00144, Italy
Azienda Ospedaliera San Camillo Forlanini /ID# 205163
Rome, Roma, 00149, Italy
Duplicate_A.O.U. San Luigi Gonzaga /ID# 204706
Orbassano, Torino, 10043, Italy
L'Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Mos /ID# 204707
Avellino, 83100, Italy
Azienda Ospedaliero-Universitaria di Parma /ID# 204983
Parma, 43126, Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 215918
Roma, 00128, Italy
Chukyo Hospital /ID# 244755
Nagoya, Aichi-ken, 457-8510, Japan
Aichi Cancer Center Hospital /ID# 207790
Nagoya, Aichi-ken, 464-8681, Japan
Hirosaki University Hospital /ID# 245023
Hirosaki-shi, Aomori, 036-8203, Japan
Duplicate_Chiba University Hospital /ID# 232204
Chiba, Chiba, 260-8677, Japan
Duplicate_National Hospital Organization Shikoku Cancer Center /ID# 232252
Matsuyama, Ehime, 791-0280, Japan
Duplicate_National Hospital Organization Kyushu Cancer Center /ID# 206061
Fukuoka, Fukuoka, 811-1395, Japan
Kurume University Hospital /ID# 227776
Kurume-shi, Fukuoka, 830-0011, Japan
Chugoku Central Hospital /ID# 245022
Fukuyama, Hiroshima, 720-0001, Japan
Hiroshima Citizens Hospital /ID# 218087
Hiroshima, Hiroshima, 730-8518, Japan
Himeji Medical Center /ID# 227777
Himeji-shi, Hyōgo, 670-8520, Japan
Kobe Minimally Invasive Cancer Center /ID# 248590
Kobe, Hyōgo, 650-0046, Japan
Takarazuka City Hospital /ID# 245185
Takarazuka-shi, Hyōgo, 665-0827, Japan
Yokohama Municipal Citizen's Hospital /ID# 248374
Yokohama, Kanagawa, 221-0855, Japan
Duplicate_Kanagawa Cancer Center /ID# 205068
Yokohama, Kanagawa, 241-8515, Japan
Matsusaka Municipal Hospital /ID# 230219
Matsusaka-shi, Mie-ken, 515-8544, Japan
Sendai Kousei Hospital /ID# 216460
Sendai, Miyagi, 980-0873, Japan
Niigata Cancer Center Hospital /ID# 216462
Niigata, Niigata, 951-8566, Japan
Okayama University Hospital /ID# 227851
Okayama, Okayama-ken, 700-8558, Japan
Osaka City General Hospital /ID# 233172
Osaka, Osaka, 534-0021, Japan
Osaka International Cancer Institute /ID# 210735
Osaka, Osaka, 5418567, Japan
NHO Kinki Chuo Chest Medical Center /ID# 216461
Sakai-shi, Osaka, 591-8555, Japan
Duplicate_Saitama Cancer Center /ID# 232508
Kitaadachi-gun, Saitama, 362-0806, Japan
Fujieda Municipal General Hospital /ID# 248589
Fujieda-shi, Shizuoka, 426-8677, Japan
Duplicate_Duplicate_Duplicate_Shizuoka Cancer Center /ID# 205065
Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital /ID# 205066
Chuo-ku, Tokyo, 104-0045, Japan
Duplicate_The Cancer Institute Hospital Of JFCR /ID# 216463
Koto-ku, Tokyo, 135-8550, Japan
Yamaguchi - Ube Medical Center /ID# 227778
Ube-shi, Yamaguchi, 755-0241, Japan
Ziekenhuis St. Jansdal /ID# 216658
Harderwijk, Gelderland, 3844 DG, Netherlands
Antoni van Leeuwenhoek /ID# 216657
Amsterdam, North Holland, 1066 CX, Netherlands
Meander Medisch Centrum /ID# 217756
Amersfoort, Utrecht, 3813 TZ, Netherlands
Med Polonia Sp. z o. o. /ID# 229908
Poznan, Greater Poland Voivodeship, 60-693, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 230595
Warsaw, Masovian Voivodeship, 02-781, Poland
Wojewodzki Szpital im. Sw. Ojca Pio /ID# 231960
Przemyśl, Podkarpackie Voivodeship, 37-700, Poland
Dom Lekarski S.A. /ID# 231479
Szczecin, West Pomeranian Voivodeship, 70-784, Poland
Duplicate_Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej /ID# 231476
Lodz, Łódź Voivodeship, 90-549, Poland
VA Caribbean Healthcare System /ID# 206336
San Juan, 00921-3201, Puerto Rico
Puerto Rico Hematology Oncolog /ID# 206337
San Juan, 00959, Puerto Rico
Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca /ID# 206320
Cluj-Napoca, Cluj, 400015, Romania
S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 227623
Craiova, Dolj, 200347, Romania
Spitalul Municipal Ploiesti /ID# 229097
Ploieşti, Prahova, 100337, Romania
Oncomed SRL /ID# 205616
Timișoara, Timiș County, 300239, Romania
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti /ID# 227216
Bucharest, 022328, Romania
Spitalul Clinic Coltea /ID# 227241
Bucharest, 030171, Romania
S.C. Gral Medical Srl /Id# 227215
Bucharest, 031422, Romania
Krasnoyarsk Regional Clinical Oncology Dispensary n.a. A.I. Kryzhanovsky /ID# 232065
Krasnoyarsk, Krasnoyarsk Krai, 660133, Russia
LLC Medical Center /ID# 212397
Novosibirsk, Novosibirsk Oblast, 630099, Russia
Clinical Oncology Dispensary of Omsk /ID# 239313
Omsk, Omsk Oblast, 644013, Russia
St. Petersburg scientific center for specialized medical care (oncological) /ID# 206405
Saint Petersburg, Sankt-Peterburg, 197758, Russia
Newclinic Medical Center /ID# 216262
Pyatigorsk, Stavropol Kray, 357519, Russia
Republican Clinical Oncology Dispensary /ID# 206463
Kazan', Tatarstan, Respublika, 420029, Russia
Regional Children's Clinical Hospital of Volgograd /ID# 206520
Volgograd, Volgograd Oblast, 400138, Russia
Arkhangelsk Clinical Oncology Dispensary /ID# 216418
Arkhangelsk, 163045, Russia
Evimed Clinic /ID# 216473
Chelyabinsk, 454048, Russia
Kostroma region oncology center /ID# 231317
Kostroma, 156005, Russia
Univercity Headache Clynic,LTD /ID# 212080
Moscow, 109028, Russia
VitaMed LLC /ID# 228957
Moscow, 121309, Russia
National Medical Research Radiological Centre /ID# 231263
Obninsk, 249036, Russia
Euromedservice /ID# 206390
Pushkin, 196603, Russia
Center of Palliative Medicine De Vita /ID# 212900
Saint Petersburg, 197343, Russia
National Cancer Center /ID# 204241
Goyang-si, Gyeonggido, 10408, South Korea
Duplicate_Seoul National University Bundang Hospital /ID# 204237
Seongnam, Gyeonggido, 13620, South Korea
The Catholic University Of Korea St. Vincent's Hospital /ID# 229647
Suwon, Gyeonggido, 16247, South Korea
Pusan National University Yangsan Hospital /ID# 233871
Yangsan, Gyeongsangnam-do, 50612, South Korea
Inha University Hospital /ID# 234206
Incheon, Incheon Gwang Yeogsi, 21565, South Korea
Chonnam National University Hwasun Hospital /ID# 206951
Hwasun-gun, Jeonranamdo, 58128, South Korea
Duplicate_Chungbuk National Univ Hosp /ID# 205680
Cheongju-si, North Chungcheong, 28644, South Korea
Asan Medical Center /ID# 204236
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Samsung Medical Center /ID# 227083
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Duplicate_Hospital Clínico Universitario de Santiago-CHUS /ID# 204367
Santiago de Compostela, A Coruna, 15706, Spain
Instituto Catalan de Oncologia (ICO) Badalona /ID# 216106
Badalona, Barcelona, 08916, Spain
CHU Insular-Materno Infantil /ID# 232362
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Hospital Universitario Fundacion Alcorcon /ID# 232361
Alcorcón, Madrid, 28922, Spain
Hospital Nuestra Senora de Sonsoles /ID# 232367
Ávila, 05004, Spain
Hospital Universitario Dexeus - Grupo Quironsalud /ID# 232368
Barcelona, 08028, Spain
Hospital Universitario Vall de Hebron /ID# 206997
Barcelona, 08035, Spain
Hospital Universitario Ramon y Cajal /ID# 203922
Madrid, 28034, Spain
Hospital Universitario HM Sanchinarro /ID# 203913
Madrid, 28050, Spain
Hospital Regional Universitario de Malaga /ID# 216081
Málaga, 29011, Spain
Hospital Universitario Virgen Macarena /ID# 230998
Seville, 41009, Spain
Hospital Universitario Virgen del Rocio /ID# 216058
Seville, 41013, Spain
Hospital Universitario y Politecnico La Fe /ID# 203862
Valencia, 46026, Spain
University Hospital Basel /ID# 230977
Basel Town, Canton of Basel-City, 4031, Switzerland
KSW Kantonsspital Winterthur /ID# 231284
Winterthur, Canton of Zurich, 8400, Switzerland
Duplicate_Kaohsiung Chang Gung Memorial Hospital /ID# 205423
Kaohsiung City, Kaohsiung, 833, Taiwan
National Taiwan University Hospital /ID# 205100
Taipei City, Taipei, 100, Taiwan
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 205309
Chiayi City, 62247, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 205831
Kaohsiung City, 807, Taiwan
Taipei Medical University Shuang Ho Hospital /ID# 215356
New Taipei City, 23561, Taiwan
Taichung Veterans General Hospital /ID# 205308
Taichung, 40705, Taiwan
National Cheng Kung University Hospital /ID# 205307
Tainan, 704, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center /ID# 227336
Taipei, 112, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 205424
Taoyuan, 333, Taiwan
Adana Sehir Egitim ve Arastirma Hastanesi /ID# 206000
Adana, 01060, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 205243
Ankara, 06200, Turkey (Türkiye)
Gazi University Medical Faculty /ID# 239816
Ankara, 06560, Turkey (Türkiye)
Akdeniz Universitesi Tip Fakul /ID# 205238
Antalya, 07059, Turkey (Türkiye)
Trakya University Medical Facu /ID# 205242
Edirne, Istanbul, 22030, Turkey (Türkiye)
Prof. Dr. Suleyman Yalcın Sehir Hastanesi /ID# 215082
Istanbul, 34722, Turkey (Türkiye)
Dr. Suat Seren Gogus Has /ID# 215083
Izmir, 35110, Turkey (Türkiye)
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 239889
London, Greater London, E1 2ES, United Kingdom
University College London Hospital /ID# 231467
London, Greater London, NW1 2BU, United Kingdom
Nottingham City Hospital /ID# 231224
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 205890
Oxford, Oxfordshire, OX3 9DU, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 206209
Birmingham, B15 2TH, United Kingdom
Related Publications (1)
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.
PMID: 38843488DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
May 17, 2018
First Posted
May 29, 2018
Study Start
October 10, 2018
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
November 5, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.