Clinical Trial - NCT03539536

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

Recruiting

Sponsor: AbbVie

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03539536

Protocol Info

Short Description: Phase 2 Telisotuzumab Vedotin in Previously Treated C-MET+ NSCLC
Long Description: 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
MGH Status: Open
Sponsor: AbbVie
Disease Program: Thoracic

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express 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).
Condition Title Intervention Phase
Non-small Cell Lung Cancer Telisotuzumab vedotin Phase 2
Study Type Interventional
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

Primary Outcome Measures

Overall Response Rate (ORR) [Time Frame: Up to approximately 3 years] [Designated as safety issue: ]


Secondary Outcome Measures

Duration of Response (DoR) [Time Frame: Up to approximately 3 years] [Designated as safety issue: ]

Disease Control Rate (DCR) [Time Frame: Up to approximately 3 years] [Designated as safety issue: ]

Duration of Disease Control (DDC) [Time Frame: Up to approximately 3 years] [Designated as safety issue: ]

Progression-Free Survival (PFS) [Time Frame: Up to approximately 3 years] [Designated as safety issue: ]

Overall Survival (OS) [Time Frame: Up to approximately 3 years] [Designated as safety issue: ]

Estimated Enrollment: 310
Study Start Date: October 2018
Estimated Study Completion Date: August 2023
Estimated Primary Completion Date: October 2021
Arms Assigned Interventions

Experimental:Telisotuzumab vedotin

Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.
Drug:Telisotuzumab vedotin
intravenous

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Histologically confirmed non-squamous cell non-small cell lung cancer (NSCLC) with known epidermal growth factor receptor (EGFR) status (wild type or mutant; with site documented status), or histologically documented squamous cell NSCLC. Of note, subjects with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met.
  • Has locally advanced or metastatic NSCLC.
  • Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory or known documented MET gene amplification.
  • If a subject meets eligibility criteria for c-Met protein expression level based on archival tissue material, or MET amplification status, subject must agree to submit tumor material for assessment of c-Met protein expression level prior to enrollment.
  • Has progressed on systemic cytotoxic therapy (or ineligible), and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible) and prior anti-cancer therapies targeting driver gene alterations (if applicable).
  • Have received no more than 2 lines of prior systemic chemotherapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the metastatic setting.
  • Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same gene alteration count as 1 line of therapy for the purposes of this eligibility criterion.
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Exclusion Criteria:

  • Has adenosquamous histology.
  • Subjects with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy).
  • Has a clinically significant condition(s) described in the protocol.
  • Has unresolved clinically significant adverse events >= grade 2 from prior anticancer therapy, except for alopecia or anemia.
  • Had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
  • Has received live vaccine within 30 days of the first dose of telisotuzumab vedotin.
  • Subjects do not have a history of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03539536

Locations

  • United States, Alabama
    • University of South Alabama /ID# 212939 Mobile, Alabama, United States, 36604-3302
  • United States, Arizona
    • Mayo Clinic Arizona /ID# 218550 Phoenix, Arizona, United States, 85054-4504
  • United States, Arkansas
    • Highlands Oncology Group /ID# 215600 Fayetteville, Arkansas, United States, 72703-4005
  • United States, California
    • UCSD Moores Cancer Center - LaJolla /ID# 218258 La Jolla, California, United States, 92093
    • University of California, Los Angeles /ID# 203219 Los Angeles, California, United States, 90095
    • Sutter Medical Center Sacramen /ID# 203299 Sacramento, California, United States, 95816
  • United States, Colorado
    • Univ of Colorado Cancer Center /ID# 203212 Aurora, Colorado, United States, 80045
    • Rocky Mountain Cancer Centers - Denver Midtown /ID# 215789 Denver, Colorado, United States, 80218
  • United States, Florida
    • Mayo Clinic /ID# 218488 Jacksonville, Florida, United States, 32224
  • United States, Hawaii
    • Straub Clinic and Hospital /ID# 217905 Honolulu, Hawaii, United States, 96813-3097
  • United States, Illinois
    • Northwestern University Feinberg School of Medicine /ID# 203239 Chicago, Illinois, United States, 60611-2927
    • University of Chicago /ID# 203216 Chicago, Illinois, United States, 60637-1443
    • NorthShore University HealthSystem - Evanston Hospital /ID# 215583 Evanston, Illinois, United States, 60201
    • Ingalls Memorial Hosp /ID# 203228 Harvey, Illinois, United States, 60426
    • Joliet Oncology-Hematology Associates, LTD /ID# 203238 Joliet, Illinois, United States, 60435
  • United States, Indiana
    • Goshen Center for Cancer Care /ID# 215584 Goshen, Indiana, United States, 46526
  • United States, Kansas
    • Univ Kansas Med Ctr /ID# 216804 Kansas City, Kansas, United States, 66160
    • Cancer Center of Kansas /ID# 203235 Wichita, Kansas, United States, 67214
  • United States, Kentucky
    • Baptist Health /ID# 203283 Lexington, Kentucky, United States, 40503-1463
    • Norton Cancer Institute /ID# 203284 Louisville, Kentucky, United States, 40207
  • United States, Maine
    • Central Maine Medical Center /ID# 216583 Lewiston, Maine, United States, 04240
  • United States, Massachusetts
    • Massachusetts General Hospital /ID# 203215 Boston, Massachusetts, United States, 02114
    • Beth Israel Deaconess Medical Center /ID# 208124 Boston, Massachusetts, United States, 02215-5400
    • Dana-Farber Cancer Institute /ID# 203248 Boston, Massachusetts, United States, 02215
  • United States, Michigan
    • University of Michigan Hospitals /ID# 215646 Ann Arbor, Michigan, United States, 48109
    • Henry Ford Hospital - West Bloomfield /ID# 203220 West Bloomfield, Michigan, United States, 48322
  • United States, Minnesota
    • Mayo Clinic - Rochester /ID# 215603 Rochester, Minnesota, United States, 55905-0001
  • United States, Missouri
    • Washington University-School of Medicine /ID# 203217 Saint Louis, Missouri, United States, 63110
  • United States, Montana
    • St. Vincent Frontier Cancer Center /ID# 203292 Billings, Montana, United States, 59102
  • United States, Nebraska
    • Univ Nebraska Med Ctr /ID# 203388 Omaha, Nebraska, United States, 68198
  • United States, New Hampshire
    • Dartmouth-Hitchcock Medical Center /ID# 203350 Lebanon, New Hampshire, United States, 03756
  • United States, New Jersey
    • Atlantic Health System /ID# 203404 Morristown, New Jersey, United States, 07960-6136
    • Overlook Medical Center /ID# 211160 Summit, New Jersey, United States, 07901-3533
  • United States, New Mexico
    • University of New Mexico /ID# 208339 Albuquerque, New Mexico, United States, 87102
  • United States, Ohio
    • Univ Hosp Cleveland /ID# 215648 Cleveland, Ohio, United States, 44106
  • United States, Oregon
    • Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301 Portland, Oregon, United States, 97225
  • United States, Pennsylvania
    • Penn State University and Milton S. Hershey Medical Center /ID# 221844 Hershey, Pennsylvania, United States, 17033-2360
    • Allegheny General Hospital /ID# 215585 Pittsburgh, Pennsylvania, United States, 15212
    • Veterans Healthcare System /ID# 215602 Pittsburgh, Pennsylvania, United States, 15240
  • United States, Tennessee
    • Vanderbilt University Med Ctr /ID# 203281 Nashville, Tennessee, United States, 37232-6307
  • United States, Texas
    • Houston Methodist Hospital - Scurlock Tower /ID# 213268 Houston, Texas, United States, 77030
    • Baylor Scott & White Medical Center- Temple /ID# 216578 Temple, Texas, United States, 76508-0001
  • United States, Virginia
    • Virginia Cancer Specialists /ID# 203224 Fairfax, Virginia, United States, 22031
  • United States, Washington
    • University of Washington /ID# 206056 Seattle, Washington, United States, 98109-1024
  • United States, Wisconsin
    • Medical College of Wisconsin /ID# 210062 Milwaukee, Wisconsin, United States, 53226-3522
  • Australia, New South Wales
    • The Kinghorn Cancer Centre /ID# 207666 Darlinghurst, New South Wales, Australia, 2010
    • Newcastle Private Hospital /ID# 206600 Lambton Heights, New South Wales, Australia, 2305
    • The Tweed Hospital /ID# 206601 Tweed Heads, New South Wales, Australia, 2485
  • Belgium,
    • UZ Antwerp /ID# 217430 Edegem, , Belgium, 2650
    • AZ Groeninge /ID# 217431 Kortrijk, , Belgium, 8500
  • Canada, Alberta
    • Cross Cancer Institute /ID# 204540 Edmonton, Alberta, Canada, T6G 1Z2
  • Canada, Ontario
    • The Ottawa Hospital /ID# 205579 Ottawa, Ontario, Canada, K1H 8L6
    • Princess Margaret Cancer Centre /ID# 204423 Toronto, Ontario, Canada, M5G 2M9
  • Canada, Quebec
    • CISSS de la Monteregie /ID# 211356 Greenfield Park, Quebec, Canada, J4V 2H1
  • China, Anhui
    • Anhui Provincial Hospital /ID# 212096 Hefei, Anhui, China, 230001
  • China, Fujian
    • Fujian Provincial Cancer Hospital /ID# 210808 Fuzhou, Fujian, China, 350014
  • China, Jilin
    • Jilin Cancer Hosptial /ID# 210563 Changchun, Jilin, China, 130000
  • China, Shanghai
    • Fudan University Shanghai Cancer Center /Id# 210084 Shanghai, Shanghai, China, 200032
  • China, Zhejiang
    • The First Affiliated Hospital,College of Medicine, Zhejiang University /ID# 211154 Hangzhou, Zhejiang, China, 310003
    • Zhejiang Cancer hospital /ID# 210085 Hangzhou, Zhejiang, China, 310022
  • China,
    • Beijing Cancer Hospital /ID# 210133 Beijing, , China, 100142
    • West China Hospital, Sichuan University /ID# 210022 Chengdu, , China, 610041
    • Shanghai Chest Hospital /ID# 210930 Shanghai, , China, 200030
    • Henan Cancer Hospital /ID# 210961 Zhengzhou Henan, , China, 450008
  • France, Bouches-du-Rhone
    • CHU Hopital Nord /ID# 209854 Marseille, Bouches-du-Rhone, France, 13915
  • France, Gironde
    • Institut Bergonie /ID# 216207 Bordeaux, Gironde, France, 33000
  • France, Ile-de-France
    • Institut Curie /ID# 207046 Paris CEDEX 05, Ile-de-France, France, 75248
  • France, Rhone
    • Centre Leon Berard /ID# 205107 Lyon CEDEX 08, Rhone, France, 69373
  • France, Val-de-Marne
    • Institut Gustave Roussy /ID# 205149 Villejuif, Val-de-Marne, France, 94800
  • France,
    • Hopital Louis Pradel /ID# 216209 Bron, , France, 69500
    • CHRU de Lille - Hopital Albert Calmette /ID# 205105 Lille, , France, 59037
    • Nouvel Hopital Civil (NHC) /ID# 208080 Strasbourg, , France, 67091
  • Germany, Sachsen-Anhalt
    • KH Martha-Maria Halle Dolau /ID# 205442 Halle (Saale), Sachsen-Anhalt, Germany, 06120
  • Germany,
    • Vivantes Klinikum Neukolln /ID# 205928 Berlin, , Germany, 12351
    • Asklepios Fachkliniken M. Gaut /ID# 207789 Gauting, , Germany, 82131
    • Evangelisches Krankenhaus Hamm /ID# 208043 Hamm, , Germany, 59063
    • Klinikum Kassel /ID# 205443 Kassel, , Germany, 34125
    • Pius Hospital Oldenburg /ID# 211615 Oldenburg, , Germany, 26121
  • Greece,
    • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 205528 Athens, , Greece, 11527
    • Metropolitan Hospital /ID# 205529 Athens, , Greece, 18547
    • University General Hospital of Heraklion PA.G.N.I /ID# 205530 Heraklion, , Greece, 71110
  • Hungary, Borsod-Abauj-Zemplen
    • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 204878 Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
  • Hungary, Pest
    • Torokbalinti Tudogyogyintezet /ID# 204883 Budapest, Pest, Hungary, 2045
  • Hungary,
    • Semmelweis Egyetem /ID# 204434 Budapest, , Hungary, 1085
    • Veszprem Megyei Tudogyogyintez /ID# 213950 Farkasgyepu, , Hungary, 8582
    • Matrahaza Gyogyintezet /ID# 204432 Kékesteto, , Hungary, 3233
  • Ireland, Dublin
    • St. James's Hospital /ID# 205104 Dublin 8, Dublin, Ireland, D08 E9P6
  • Ireland,
    • Cork University Hospital /ID# 205103 Cork, , Ireland, T12 E8YV
    • St Vincent's University Hosp /ID# 205102 Dublin, , Ireland, D04 T6F4
  • Israel, HaDarom
    • Soroka Medical Center /ID# 204898 Be'er Sheva, HaDarom, Israel, 84101
  • Israel, Tel-Aviv
    • Rabin Medical Center /ID# 215322 Petakh Tikva, Tel-Aviv, Israel, 4941492
  • Israel,
    • Rambam Health Care Campus /ID# 204866 Haifa, , Israel, 3109601
    • Meir Medical Center /ID# 204255 Kfar Saba, , Israel, 4428164
    • Sheba Medical Center /ID# 204254 Ramat Gan, , Israel, 5239424
  • Italy, Emilia-Romagna
    • IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 205601 Meldola, Emilia-Romagna, Italy, 47014
  • Italy, Lazio
    • Policlinico Universitario Campus Bio-Medico /ID# 215918 Rome, Lazio, Italy, 00128
    • Azienda Ospedaliera San Camillo Forlanini /ID# 205163 Rome, Lazio, Italy, 00152
  • Italy,
    • AO San Giuseppe Moscati /ID# 204707 Avellino, , Italy, 83100
    • A.O.U. San Luigi Gonzaga /ID# 204706 Orbassano, , Italy, 10043
    • Azienda Ospedaliero Uni Parma /ID# 204983 Parma, , Italy, 43100
  • Japan, Fukuoka
    • National Hospital Organization Kyushu Cancer Center /ID# 206061 Fukuoka-shi, Fukuoka, Japan, 811-1395
  • Japan, Osaka
    • Kinki-Chuo Chest Medical Center /ID# 216461 Kita-ku, Osaka, Japan, 591-8555
  • Japan, Shizuoka
    • Shizuoka Cancer Center /ID# 205065 Sunto-gun, Shizuoka, Japan, 411-8777
  • Japan, Tokyo
    • National Cancer Center Hospital /ID# 205066 Chuo-ku, Tokyo, Japan, 104-0045
    • The Cancer Institute Hospital Of JFCR /ID# 216463 Koto-ku, Tokyo, Japan, 135-8550
  • Japan,
    • Hiroshima Citizens Hospital /ID# 218087 Hiroshima, , Japan, 730-8518
    • Niigata Cancer Center Hospital /ID# 216462 Niigata-shi, , Japan, 951-8566
    • Osaka Inter. Cancer Institute /ID# 210735 Osaka, , Japan, 541-8567
    • Sendai Kousei Hospital /ID# 216460 Sendai, , Japan, 980-0873
    • Kanagawa Cancer Center /ID# 205068 Yokohama, , Japan, 241-0815
  • Korea, Republic of, Gyeonggido
    • National Cancer Center /ID# 204241 Goyang, Gyeonggido, Korea, Republic of, 10408
    • Seoul National Univ Bundang ho /ID# 204237 Seongnam, Gyeonggido, Korea, Republic of, 13620
  • Korea, Republic of,
    • Chungbuk National Univ Hosp /ID# 205680 Cheongju, , Korea, Republic of, 28644
    • Chonnam National University Hwasun Hospital /ID# 206951 Jeonnam, , Korea, Republic of, 58128
    • Asan Medical Center /ID# 204236 Seoul, , Korea, Republic of, 05505
  • Netherlands, Noord-Holland
    • Antoni van Leeuwenhoek /ID# 216657 Amsterdam, Noord-Holland, Netherlands, 1066 CX
  • Netherlands,
    • Meander Medisch Centrum /ID# 217756 Amersfoort, , Netherlands, 3813 TZ
    • Ziekenhuis St. Jansdal /ID# 216658 Harderwijk, , Netherlands, 3844 DG
  • Puerto Rico,
    • VA Caribbean Healthcare System /ID# 206336 San Juan, , Puerto Rico, 00921-3201
    • Puerto Rico Hematology Oncolog /ID# 206337 San Juan, , Puerto Rico, 00959
  • Romania,
    • Institutul Oncologic /ID# 206320 Cluj Napoca, , Romania, 400015
    • Oncomed SRL /ID# 205616 Timisoara, , Romania, 300239
  • Russian Federation, Novosibirskaya Oblast
    • "Avicenna" medical center /ID# 212397 Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630099
  • Russian Federation, Tatarstan, Respublika
    • Tatarstan Cancer Center /ID# 206463 Kazan, Tatarstan, Respublika, Russian Federation, 420029
  • Russian Federation, Volgogradskaya Oblast
    • Volgograd Regional Clinical Oncology Dispensary /ID# 206520 Volgograd, Volgogradskaya Oblast, Russian Federation, 400138
  • Russian Federation,
    • Arkhangelsk clinical oncology /ID# 216418 Arkhangelsk, , Russian Federation, 163045
    • LLC Evimed /ID# 216473 Chelyabinsk, , Russian Federation, 454048
    • Univercity Headache Clynic,LTD /ID# 212080 Moscow, , Russian Federation, 109028
    • PMI Euromedservice /ID# 206390 Pushkin, , Russian Federation, 196603
    • LLC Novaya Clinica /ID# 216262 Pyatigorsk, , Russian Federation, 357502
    • OOO Centre of Palliative Medicine De Vita /ID# 212900 Saint Petersburg, , Russian Federation, 197343
    • St.Petersburg City Cancer Center /ID# 206405 Sankt-Peterburg, , Russian Federation, 198218
  • Spain, A Coruna
    • Hospital Clínico Universitario de Santiago /ID# 204367 Santiago de Compostela, A Coruna, Spain, 15706
  • Spain, Barcelona
    • Instituto Catalan de Oncologia (ICO) Badalona /ID# 216106 Badalona, Barcelona, Spain, 08916
  • Spain, Malaga
    • Hospital Regional Universitario de Malaga /ID# 216081 Málaga, Malaga, Spain, 29010
  • Spain, Valenciana
    • Hospital Universitario y Politecnico La Fe /ID# 203862 Valencia, Valenciana, Spain, 46026
  • Spain,
    • Hospital Vall d'Hebron /ID# 206997 Barcelona, , Spain, 8035
    • Hospital Univ Ramon y Cajal /ID# 203922 Madrid, , Spain, 28034
    • Hosp Univ Madrid Sanchinarro /ID# 203913 Madrid, , Spain, 28050
    • Hosp Univ Virgen del Rocio /ID# 216058 Sevilla, , Spain, 41001
  • Taiwan, Tainan
    • National Cheng Kung University Hospital /ID# 205307 Tainan City, Tainan, Taiwan, 70403
  • Taiwan, Taipei
    • National Taiwan University Hospital /ID# 205100 Taipei City, Taipei, Taiwan, 100
  • Taiwan,
    • Dalin Tzu Chi General Hospital /ID# 205309 Dalin Township, , Taiwan, 622
    • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 205831 Kaohsiung, , Taiwan, 80708
    • Taipei Med Univ Shuang Ho Hosp /ID# 215356 New Taipei City, , Taiwan, 23561
    • Taichung Veterans General Hosp /ID# 205308 Taichung City, , Taiwan, 40705
    • Linkou Chang Gung Memorial Ho /ID# 205424 Taoyuan City, , Taiwan, 33305
  • Turkey,
    • Adana Sehir Egitim ve Arastirma Hastanesi /ID# 206000 Adana, , Turkey, 01060
    • Dr. Abdurrahman Yurtaslan Ankara Onkoloji EÄŸitim ve AraÅŸtırma Hastanesi /ID# 205243 Ankara, , Turkey, 06200
    • Akdeniz Universitesi Tip Fakul /ID# 205238 Antalya, , Turkey, 07059
    • Trakya University Medical Facu /ID# 205242 Edirne, Istanbul, , Turkey, 22030
    • Istanbul Medeniyet Universites /ID# 215082 Istanbul, , Turkey, 34722
    • Dr. Suat Seren Gogus Has /ID# 215083 Izmir, , Turkey, 35110
  • United Kingdom,
    • Heart of England NHS Foundation Trust /ID# 206209 Birmingham, , United Kingdom, B9 5SS
    • Oxford Univ Hosp NHS Trust /ID# 205890 Oxford, , United Kingdom, OX3 7LE

Sponsors and Collaborators

AbbVie

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03539536
Other Study ID Numbers: 2018-001772-38
Study First Received:
Last Updated:
Health Authority:

Keywords provided by AbbVie:

Non-small Cell Lung Cancer (NSCLC)

Cancer

Telisotuzumab vedotin

ABBV-399

c-Met, c-Met overexpression

metastatic

MET gene amplification

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on September 03, 2020