AzTrials
AzTrials

Non-small Cell Lung CancerPhase 2NCT03539536

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

A Phase 2 study testing Telisotuzumab vedotin in people with Non-small Cell Lung Cancer, run by AbbVie at 252 sites in 26 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Telisotuzumab vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
252 sitesin 26 countries
Study dates
10 Oct 2018to Aug 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

252 sites in 26 countries.

252 sites in 26 countries

United States56 sites

  • University of New Mexico /ID# 208339

    Albuquerque, New Mexico, 87102-4517

  • Univ of Colorado Cancer Center /ID# 203212

    Aurora, Colorado, 80045

  • Duplicate_Intermountain Health - St Vincent Regional Hospital - Cancer Centers o /ID# 203292

    Billings, Montana, 59102

  • Massachusetts General Hospital /ID# 203215

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center /ID# 208124

    Boston, Massachusetts, 02215-5400

  • Dana-Farber Cancer Institute /ID# 203248

    Boston, Massachusetts, 02215

  • Advanced Cancer Treatment Center /ID# 239565

    Brooksville, Florida, 34613-6072

  • Duplicate_Gabrail Cancer Center Research /ID# 216056

    Canton, Ohio, 44718

  • AdventHealth Celebration /ID# 215649

    Celebration, Florida, 34747-4970

  • Northwestern University Feinberg School of Medicine /ID# 203239

    Chicago, Illinois, 60611-2927

  • The University of Chicago Medical Center /ID# 203216

    Chicago, Illinois, 60637-1443

  • Univ Hosp Cleveland /ID# 215648

    Cleveland, Ohio, 44106

  • Henry Ford Hospital /ID# 203220

    Detroit, Michigan, 48202

  • Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 228868

    East Brunswick, New Jersey, 08816

  • Mercy Cancer Center /ID# 231972

    Elyria, Ohio, 44024

  • Duplicate_NorthShore University HealthSystem /ID# 215583

    Evanston, Illinois, 60201

  • Virginia Cancer Specialists - Fairfax /ID# 203224

    Fairfax, Virginia, 22031

  • Goshen Center for Cancer Care /ID# 215584

    Goshen, Indiana, 46526

  • Ingalls Memorial Hosp /ID# 203228

    Harvey, Illinois, 60426

  • Hattiesburg Clinic /ID# 227691

    Hattiesburg, Mississippi, 39401

  • Penn State University and Milton S. Hershey Medical Center /ID# 221844

    Hershey, Pennsylvania, 17033-2360

  • Straub Clinic and Hospital /ID# 217905

    Honolulu, Hawaii, 96813-3097

  • Houston Methodist Hospital /ID# 213268

    Houston, Texas, 77030

  • Duplicate_Mayo Clinic /ID# 218488

    Jacksonville, Florida, 32224

  • Joliet Oncology-Hematology Associates, LTD /ID# 203238

    Joliet, Illinois, 60435

  • Univ Kansas Med Ctr /ID# 216804

    Kansas City, Kansas, 66160

  • St. Lukes Cancer Institute /ID# 227697

    Kansas City, Missouri, 64111-5905

  • Thompson Cancer Survival Ctr /ID# 228874

    Knoxville, Tennessee, 37916

  • Duplicate_Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 203350

    Lebanon, New Hampshire, 03756

  • Central Maine Medical Center /ID# 216583

    Lewiston, Maine, 04240

  • Duplicate_Baptist Health /ID# 203283

    Lexington, Kentucky, 40503-1463

  • Duplicate_Rocky Mountain Cancer Centers - Lone Tree /ID# 215789

    Lone Tree, Colorado, 80124

  • University of California, Los Angeles /ID# 203219

    Los Angeles, California, 90095

  • Duplicate_Norton Cancer Institute - St Matthews /ID# 203284

    Louisville, Kentucky, 40207

  • Wisconsin Medical Center /ID# 210062

    Milwaukee, Wisconsin, 53226

  • University of South Alabama /ID# 212939

    Mobile, Alabama, 36604-3302

  • Atlantic Health System /ID# 203404

    Morristown, New Jersey, 07960-6136

  • Vanderbilt Ingram Cancer Center /ID# 203281

    Nashville, Tennessee, 37232-0021

  • Mercy Research Mercy Clinic Oklahoma Communities, Inc. / OKC /ID# 230154

    Oklahoma City, Oklahoma, 73120

  • LA Hematology-Oncology Med Group /ID# 203338

    Orange, California, 92868

  • Duplicate_AdventHealth Cancer Institute - Orlando /ID# 239960

    Orlando, Florida, 32804

  • Capital Health Medical Center /ID# 203403

    Pennington, New Jersey, 08534-2520

  • Mayo Clinic Arizona /ID# 218550

    Phoenix, Arizona, 85054-4504

  • Duplicate_Allegheny General Hospital /ID# 215585

    Pittsburgh, Pennsylvania, 15212

  • Veterans Healthcare System /ID# 215602

    Pittsburgh, Pennsylvania, 15240

  • Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301

    Portland, Oregon, 97225

  • Valley Medical Center /ID# 231459

    Renton, Washington, 98055-5738

  • Mayo Clinic - Rochester /ID# 215603

    Rochester, Minnesota, 55905-0001

  • Sutter Medical Center Sacramen /ID# 203299

    Sacramento, California, 95816

  • University of Washington /ID# 206056

    Seattle, Washington, 98109

  • Highlands Oncology Group, PA /ID# 215600

    Springdale, Arkansas, 72762

  • Washington University-School of Medicine /ID# 203217

    St Louis, Missouri, 63110

  • Overlook Medical Center /ID# 211160

    Summit, New Jersey, 07901-3533

  • Baylor Scott & White Medical Center- Temple /ID# 216578

    Temple, Texas, 76508-0001

  • Icri /Id# 227835

    Whittier, California, 90603

  • Cancer Center of Kansas /ID# 203235

    Wichita, Kansas, 67214

Other trials in United States

Japan27 sites

  • Duplicate_Chiba University Hospital /ID# 232204

    Chiba, Chiba, 260-8677

  • National Cancer Center Hospital /ID# 205066

    Chuo-ku, Tokyo, 104-0045

  • Fujieda Municipal General Hospital /ID# 248589

    Fujieda-shi, Shizuoka, 426-8677

  • Duplicate_National Hospital Organization Kyushu Cancer Center /ID# 206061

    Fukuoka, Fukuoka, 811-1395

  • Chugoku Central Hospital /ID# 245022

    Fukuyama, Hiroshima, 720-0001

  • Himeji Medical Center /ID# 227777

    Himeji-shi, Hyōgo, 670-8520

  • Hirosaki University Hospital /ID# 245023

    Hirosaki-shi, Aomori, 036-8203

  • Hiroshima Citizens Hospital /ID# 218087

    Hiroshima, Hiroshima, 730-8518

  • Duplicate_Saitama Cancer Center /ID# 232508

    Kitaadachi-gun, Saitama, 362-0806

  • Kobe Minimally Invasive Cancer Center /ID# 248590

    Kobe, Hyōgo, 650-0046

  • Duplicate_The Cancer Institute Hospital Of JFCR /ID# 216463

    Koto-ku, Tokyo, 135-8550

  • Kurume University Hospital /ID# 227776

    Kurume-shi, Fukuoka, 830-0011

  • Matsusaka Municipal Hospital /ID# 230219

    Matsusaka-shi, Mie-ken, 515-8544

  • Duplicate_National Hospital Organization Shikoku Cancer Center /ID# 232252

    Matsuyama, Ehime, 791-0280

  • Chukyo Hospital /ID# 244755

    Nagoya, Aichi-ken, 457-8510

  • Aichi Cancer Center Hospital /ID# 207790

    Nagoya, Aichi-ken, 464-8681

  • Niigata Cancer Center Hospital /ID# 216462

    Niigata, Niigata, 951-8566

  • Okayama University Hospital /ID# 227851

    Okayama, Okayama-ken, 700-8558

  • Osaka City General Hospital /ID# 233172

    Osaka, Osaka, 534-0021

  • Osaka International Cancer Institute /ID# 210735

    Osaka, Osaka, 5418567

  • NHO Kinki Chuo Chest Medical Center /ID# 216461

    Sakai-shi, Osaka, 591-8555

  • Sendai Kousei Hospital /ID# 216460

    Sendai, Miyagi, 980-0873

  • Duplicate_Duplicate_Duplicate_Shizuoka Cancer Center /ID# 205065

    Sunto-gun, Shizuoka, 411-8777

  • Takarazuka City Hospital /ID# 245185

    Takarazuka-shi, Hyōgo, 665-0827

  • Yamaguchi - Ube Medical Center /ID# 227778

    Ube-shi, Yamaguchi, 755-0241

  • Yokohama Municipal Citizen's Hospital /ID# 248374

    Yokohama, Kanagawa, 221-0855

  • Duplicate_Kanagawa Cancer Center /ID# 205068

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

China20 sites

  • Affiliated Hospital of Hebei University /ID# 227262

    Baoding, Hebei, 071000

  • Beijing Cancer Hospital /ID# 210133

    Beijing, Beijing Municipality, 100142

  • Jilin Cancer Hospital /ID# 210563

    Changchun, Jilin, 130012

  • The First People's Hospital of Changzhou /ID# 210787

    Changzhou, Jiangsu, 213003

  • West China Hospital, Sichuan University /ID# 210022

    Chengdu, Sichuan, 610041

  • Fujian Provincial Cancer Hospital /ID# 210808

    Fuzhou, Fujian, 350014

  • The First Affiliated Hospital Of Guangzhou Medical University /ID# 232261

    Guangzhou, Guangdong, 510163

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 211154

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer hospital /ID# 210085

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital /Id# 231573

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Hospital /ID# 212096

    Hefei, Anhui, 230001

  • Anhui Provincial Cancer Hospital /ID# 239058

    Hefei, Anhui, 230031

  • Anhui Medical University - Anhui Chest Hospital /ID# 239048

    Hefei, Anhui, 230032

  • Shandong Cancer Hospital /ID# 231577

    Jinan, Shandong, 251601

  • Affiliated Cancer Hospital of Guangxi Medical University /ID# 231560

    Nanning, Guangxi, 530021

  • Shanghai Chest Hospital /ID# 210930

    Shanghai, Shanghai Municipality, 200030

  • Fudan University Cancer Hospital /ID# 210084

    Shanghai, Shanghai Municipality, 200032

  • The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 227244

    Ürümqi, Xinjiang, 830000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211119

    Wuhan, Hubei, 430022

  • Henan Cancer Hospital /ID# 210961

    Zhengzhou, Henan, 450008

Other trials in China

Russia15 sites

  • Arkhangelsk Clinical Oncology Dispensary /ID# 216418

    Arkhangelsk, 163045

  • Evimed Clinic /ID# 216473

    Chelyabinsk, 454048

  • Republican Clinical Oncology Dispensary /ID# 206463

    Kazan', Tatarstan, Respublika, 420029

  • Kostroma region oncology center /ID# 231317

    Kostroma, 156005

  • Krasnoyarsk Regional Clinical Oncology Dispensary n.a. A.I. Kryzhanovsky /ID# 232065

    Krasnoyarsk, Krasnoyarsk Krai, 660133

  • Univercity Headache Clynic,LTD /ID# 212080

    Moscow, 109028

  • VitaMed LLC /ID# 228957

    Moscow, 121309

  • LLC Medical Center /ID# 212397

    Novosibirsk, Novosibirsk Oblast, 630099

  • National Medical Research Radiological Centre /ID# 231263

    Obninsk, 249036

  • Clinical Oncology Dispensary of Omsk /ID# 239313

    Omsk, Omsk Oblast, 644013

  • Euromedservice /ID# 206390

    Pushkin, 196603

  • Newclinic Medical Center /ID# 216262

    Pyatigorsk, Stavropol Kray, 357519

  • St. Petersburg scientific center for specialized medical care (oncological) /ID# 206405

    Saint Petersburg, Sankt-Peterburg, 197758

  • Center of Palliative Medicine De Vita /ID# 212900

    Saint Petersburg, 197343

  • Regional Children's Clinical Hospital of Volgograd /ID# 206520

    Volgograd, Volgograd Oblast, 400138

Other trials in Russia

Spain13 sites

  • Hospital Universitario Fundacion Alcorcon /ID# 232361

    Alcorcón, Madrid, 28922

  • Hospital Nuestra Senora de Sonsoles /ID# 232367

    Ávila, 05004

  • Instituto Catalan de Oncologia (ICO) Badalona /ID# 216106

    Badalona, Barcelona, 08916

  • Hospital Universitario Dexeus - Grupo Quironsalud /ID# 232368

    Barcelona, 08028

  • Hospital Universitario Vall de Hebron /ID# 206997

    Barcelona, 08035

  • CHU Insular-Materno Infantil /ID# 232362

    Las Palmas de Gran Canaria, Las Palmas, 35016

  • Hospital Universitario Ramon y Cajal /ID# 203922

    Madrid, 28034

  • Hospital Universitario HM Sanchinarro /ID# 203913

    Madrid, 28050

  • Hospital Regional Universitario de Malaga /ID# 216081

    Málaga, 29011

  • Duplicate_Hospital Clínico Universitario de Santiago-CHUS /ID# 204367

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Virgen Macarena /ID# 230998

    Seville, 41009

  • Hospital Universitario Virgen del Rocio /ID# 216058

    Seville, 41013

  • Hospital Universitario y Politecnico La Fe /ID# 203862

    Valencia, 46026

Other trials in Spain

France10 sites

  • Institut Bergonie /ID# 216207

    Bordeaux, Gironde, 33000

  • Hospices Civils de Lyon (HCL) - Hopital Louis Pradel /ID# 216209

    Bron, Rhone, 69500

  • Centre Hosp Intercommunal de Creteil /ID# 227108

    Créteil, Val-de-Marne, 94000

  • CHU Lille - Hôpital Albert Calmette /ID# 205105

    Lille, Hauts-de-France, 59037

  • Centre Leon Berard /ID# 205107

    Lyon, Rhone, 69373

  • APHM - Hopital Nord /ID# 209854

    Marseille, Bouches-du-Rhone, 13015

  • Institut Curie /ID# 207046

    Paris, Paris, 75248

  • CHU Strasbourg - Hopital Civil /ID# 208080

    Strasbourg, 67091

  • CHI Toulon-La Seyne sur Mer /ID# 230545

    Toulon, Var, 83056

  • Institut Gustave Roussy /ID# 205149

    Villejuif, Val-de-Marne, 94805

Other trials in France

Italy10 sites

  • L'Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Mos /ID# 204707

    Avellino, 83100

  • Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 216153

    Bologna, Emilia-Romagna, 40138

  • Duplicate_Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 205601

    Meldola, Forlì-Cesena, 47014

  • IRCCS Ospedale San Raffaele /ID# 226973

    Milan, Milano, 20132

  • Azienda Ospedaliera Universitaria Federico II /ID# 231948

    Naples, Napoli, 80131

  • Duplicate_A.O.U. San Luigi Gonzaga /ID# 204706

    Orbassano, Torino, 10043

  • Azienda Ospedaliero-Universitaria di Parma /ID# 204983

    Parma, 43126

  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 215918

    Roma, 00128

  • Duplicate_IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Reg /ID# 227011

    Rome, Roma, 00144

  • Azienda Ospedaliera San Camillo Forlanini /ID# 205163

    Rome, Roma, 00149

Other trials in Italy

Belgium9 sites

  • Institut Jules Bordet /ID# 238614

    Anderlecht, 1070

  • Universitair Ziekenhuis Antwerpen /ID# 217430

    Edegem, Antwerpen, 2650

  • AZ Maria Middelares /ID# 233474

    Ghent, 9000

  • Jessa Ziekenhuis /ID# 234047

    Hasselt, Limburg, 3500

  • AZ Groeninge /ID# 217431

    Kortrijk, 8500

  • Hospital La Louviere Site Jolimont - Helora /ID# 230586

    La Louvière, Hainaut, 7100

  • Duplicate_CHU de Liege /ID# 230589

    Liège, 4000

  • UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 234048

    Namur, 5000

  • Vitaz /Id# 239966

    Sint-Niklaas, Oost-Vlaanderen, 9100

Other trials in Belgium

Germany9 sites

  • Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 232052

    Augsburg, Bavaria, 86150

  • Vivantes Klinikum Neukolln /ID# 205928

    Berlin, 12351

  • Asklepios Fachkliniken Muenchen-Gauting /ID# 207789

    Gauting, 82131

  • Universitaetsklinikum Giessen /ID# 231856

    Giessen, Hesse, 35392

  • Krankenhaus Martha-Maria Halle-Doelau /ID# 205442

    Halle, Saxony-Anhalt, 06120

  • Evangelisches Krankenhaus Hamm /ID# 208043

    Hamm, 59063

  • Klinikum Kassel /ID# 205443

    Kassel, Hesse, 34125

  • Universitatsklinikum Mannheim /ID# 228798

    Mannheim, Baden-Wurttemberg, 68167

  • Pius-Hospital Oldenburg /ID# 211615

    Oldenburg, Lower Saxony, 26121

Other trials in Germany

South Korea9 sites

  • Duplicate_Chungbuk National Univ Hosp /ID# 205680

    Cheongju-si, North Chungcheong, 28644

  • National Cancer Center /ID# 204241

    Goyang-si, Gyeonggido, 10408

  • Chonnam National University Hwasun Hospital /ID# 206951

    Hwasun-gun, Jeonranamdo, 58128

  • Inha University Hospital /ID# 234206

    Incheon, Incheon Gwang Yeogsi, 21565

  • Duplicate_Seoul National University Bundang Hospital /ID# 204237

    Seongnam, Gyeonggido, 13620

  • Asan Medical Center /ID# 204236

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center /ID# 227083

    Seoul, Seoul Teugbyeolsi, 06351

  • The Catholic University Of Korea St. Vincent's Hospital /ID# 229647

    Suwon, Gyeonggido, 16247

  • Pusan National University Yangsan Hospital /ID# 233871

    Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

Taiwan9 sites

  • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 205309

    Chiayi City, 62247

  • Duplicate_Kaohsiung Chang Gung Memorial Hospital /ID# 205423

    Kaohsiung City, Kaohsiung, 833

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 205831

    Kaohsiung City, 807

  • Taipei Medical University Shuang Ho Hospital /ID# 215356

    New Taipei City, 23561

  • Taichung Veterans General Hospital /ID# 205308

    Taichung, 40705

  • National Cheng Kung University Hospital /ID# 205307

    Tainan, 704

  • Koo Foundation Sun Yat-Sen Cancer Center /ID# 227336

    Taipei, 112

  • National Taiwan University Hospital /ID# 205100

    Taipei City, Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 205424

    Taoyuan City, 333

Other trials in Taiwan

Romania7 sites

  • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti /ID# 227216

    Bucharest, 022328

  • Spitalul Clinic Coltea /ID# 227241

    Bucharest, 030171

  • S.C. Gral Medical Srl /Id# 227215

    Bucharest, 031422

  • Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca /ID# 206320

    Cluj-Napoca, Cluj, 400015

  • S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 227623

    Craiova, Dolj, 200347

  • Spitalul Municipal Ploiesti /ID# 229097

    Ploieşti, Prahova, 100337

  • Oncomed SRL /ID# 205616

    Timișoara, Timiș County, 300239

Other trials in Romania

Turkey (Türkiye)7 sites

  • Adana Sehir Egitim ve Arastirma Hastanesi /ID# 206000

    Adana, 01060

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 205243

    Ankara, 06200

  • Gazi University Medical Faculty /ID# 239816

    Ankara, 06560

  • Akdeniz Universitesi Tip Fakul /ID# 205238

    Antalya, 07059

  • Trakya University Medical Facu /ID# 205242

    Edirne, Istanbul, 22030

  • Prof. Dr. Suleyman Yalcın Sehir Hastanesi /ID# 215082

    Istanbul, 34722

  • Dr. Suat Seren Gogus Has /ID# 215083

    Izmir, 35110

Other trials in Turkey (Türkiye)

Australia5 sites

  • The Kinghorn Cancer Centre /ID# 207666

    Darlinghurst, New South Wales, 2010

  • Newcastle Private Hospital /ID# 206600

    Lambton Heights, New South Wales, 2305

  • Mater Misericordiae Limited /ID# 229639

    South Brisbane, Queensland, 4101

  • St John Of God Subiaco Hospital /ID# 226943

    Subiaco, Western Australia, 6008

  • The Tweed Hospital /ID# 206601

    Tweed Heads, New South Wales, 2485

Other trials in Australia

Greece5 sites

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 205528

    Athens, Attica, 11527

  • University General Hospital of Heraklion PA.G.N.I /ID# 205530

    Heraklion, Crete, 71500

  • Metropolitan Hospital /ID# 205529

    Piraeus, Attica, 18547

  • Bioclinic Thessaloniki /ID# 227261

    Thessaloniki, 54622

  • Euromedica General Clinic /ID# 227264

    Thessaloniki, 54645

Other trials in Greece

Hungary5 sites

  • Duplicate_Semmelweis Egyetem /ID# 204434

    Budapest, 1085

  • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 204878

    Encs, Borsod-Abauj Zemplen county, 3860

  • Duplicate_Veszprem Megyei Tudogyogyintez /ID# 213950

    Farkasgyepű, 8582

  • Matrai Gyogyintezet /ID# 204432

    Mátraháza, 3233

  • Torokbalinti Tudogyogyintezet /ID# 204883

    Törökbálint, Pest County, 2045

Other trials in Hungary

Israel5 sites

  • Soroka University Medical Center /ID# 204898

    Beersheba, Southern District, 8443901

  • Rambam Health Care Campus /ID# 204866

    Haifa, 3109601

  • Meir Medical Center /ID# 204255

    Kfar Saba, Central District, 4428164

  • Rabin Medical Center /ID# 215322

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 204254

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

Poland5 sites

  • Duplicate_Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej /ID# 231476

    Lodz, Łódź Voivodeship, 90-549

  • Med Polonia Sp. z o. o. /ID# 229908

    Poznan, Greater Poland Voivodeship, 60-693

  • Wojewodzki Szpital im. Sw. Ojca Pio /ID# 231960

    Przemyśl, Podkarpackie Voivodeship, 37-700

  • Dom Lekarski S.A. /ID# 231479

    Szczecin, West Pomeranian Voivodeship, 70-784

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 230595

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

United Kingdom5 sites

  • University Hospitals Birmingham NHS Foundation Trust /ID# 206209

    Birmingham, B15 2TH

  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 239889

    London, Greater London, E1 2ES

  • University College London Hospital /ID# 231467

    London, Greater London, NW1 2BU

  • Nottingham City Hospital /ID# 231224

    Nottingham, Nottinghamshire, NG5 1PB

  • Oxford University Hospitals NHS Foundation Trust /ID# 205890

    Oxford, Oxfordshire, OX3 9DU

Other trials in United Kingdom

Bulgaria4 sites

  • MHAT Dobrich /ID# 230074

    Dobrich, 9300

  • UMHAT Dr Georgi Stranski EAD /ID# 232024

    Pleven, 5800

  • Medical Center Nadezhda /ID# 230473

    Sofia, 1330

  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 232010

    Sofia, 1407

Other trials in Bulgaria

Canada4 sites

  • Duplicate_Cross Cancer Institute /ID# 204540

    Edmonton, Alberta, T6G 1Z2

  • CISSS de la Monteregie /ID# 211356

    Greenfield Park, Quebec, J4V 2H1

  • Ottawa Hospital Research Institute /ID# 205579

    Ottawa, Ontario, K1H 8L6

  • University Health Network_Princess Margaret Cancer Centre /ID# 204423

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Ireland4 sites

  • Mater Misericordiae Univ Hospital /ID# 231466

    Dublin, Dublin, D07 R2WY

  • St James Hospital /ID# 205104

    Dublin, Dublin, D08 NHY1

  • St Vincents University Hospital /ID# 205102

    Elm Park, Dublin, D04 T6F4

  • Cork University Hospital /ID# 205103

    Wilton, Cork, T12 E8YV

Other trials in Ireland

Netherlands3 sites

  • Meander Medisch Centrum /ID# 217756

    Amersfoort, Utrecht, 3813 TZ

  • Antoni van Leeuwenhoek /ID# 216657

    Amsterdam, North Holland, 1066 CX

  • Ziekenhuis St. Jansdal /ID# 216658

    Harderwijk, Gelderland, 3844 DG

Other trials in Netherlands

Czechia2 sites

  • Duplicate_Vseobecna fakultni nemocnice v Praze /ID# 229797

    Prague, Praha 17, 128 08

  • Multiscan s.r.o. /ID# 241926

    Prague, 155 00

Other trials in Czechia

Puerto Rico2 sites

  • VA Caribbean Healthcare System /ID# 206336

    San Juan, 00921-3201

  • Puerto Rico Hematology Oncolog /ID# 206337

    San Juan, 00959

Other trials in Puerto Rico

Switzerland2 sites

  • University Hospital Basel /ID# 230977

    Basel Town, Canton of Basel-City, 4031

  • KSW Kantonsspital Winterthur /ID# 231284

    Winterthur, Canton of Zurich, 8400

Other trials in Switzerland

About this study

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

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).

Being tested
Telisotuzumab vedotin
Keywords
Non-small Cell Lung Cancer (NSCLC), Cancer, Telisotuzumab vedotin, ABBV-399, c-Met, c-Met overexpression, metastatic, MET gene amplification, LUMINOSITY
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telisotuzumab vedotinDrug

    Also called ABBV-399

    Intravenous (IV) infusion

Study groups in NCT03539536
Study groupRoleWhat they receive
Telisotuzumab vedotinExperimentalTelisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.
Receives: Drug: Telisotuzumab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 3 years

  2. 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.

    Measured: Up to approximately 3 years

Secondary outcomes (4)

  1. 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.

    Measured: Up to approximately 3 years

  2. 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.

    Measured: Up to approximately 3 years

  3. 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.

    Measured: Up to approximately 3 years

  4. 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.

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2018
  2. Study start10 Oct 2018
  3. Primary completionJul 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03539536
Sponsor's protocol ID
M14-239
Other IDs
2023-507902-15-00, 2023
Status last verified
Nov 2025
First submitted
17 May 2018
Last updated
5 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Publications

  • Girard N, Goldman J, Lu S, Bar J, Horinouchi H, Daaboul N, Liu C, Cicin I, Katgi N, Zer A, Ciuleanu T, Reinmuth N, Planchard D, Lee SH, Mansfield AS, Moskovitz M, Baijal S, Baik C, Hrom JS, Heist RS, Yazici O, Verma M, Uema D, Patel S, Xia S, Ratajczak C, Camidge DR. Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein Overexpressing, Nonsquamous, EGFR Wild-type Advanced NSCLC: Updated Analysis of the LUMINOSITY Trial. JTO Clin Res Rep. 2026 Mar 16;7(7):100988. doi: 10.1016/j.jtocrr.2026.100988. eCollection 2026 Jul.

    PubMed 42368479

  • 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.

    PubMed 38843488

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telisotuzumab vedotin in people with Non-small Cell Lung Cancer, run by AbbVie at 252 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 252 sites in United States, Japan, China, Russia, Spain and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (Stage 1 and Stage 2) (time frame: Up to approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03539536, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.

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