A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Start Date
1/20/2025
Completion Date
2/1/2028
Summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 80 to 90 sites worldwide. Participants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Telisotuzumab Vedotin
Conditions
Locations
Ironwood Cancer and Research Center /ID# 276370
Chandler, Arizona 85224
United States
University of Arkansas for Medical Sciences /ID# 272923
Little Rock, Arkansas 72205
United States
Valkyrie Clinical Trials /ID# 271322
Los Angeles, California 90067
United States
Yale New Haven Hospital /ID# 271584
New Haven, Connecticut 06510
United States
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899
Jacksonville, Florida 32256
United States
Ocala Oncology Center /ID# 273697
Ocala, Florida 34474
United States
Memorial Hospital West /ID# 270313
Pembroke Pines, Florida 33028
United States
Comprehensive Hematology Oncology /ID# 270422
St. Petersburg, Florida 33701-4732
United States
Florida Cancer Specialists - North /ID# 271995
St. Petersburg, Florida 33705
United States
Florida Cancer Specialists - East /ID# 271993
West Palm Beach, Florida 33401
United States
University Cancer & Blood Center /ID# 270969
Athens, Georgia 30607
United States
Northwest Georgia Oncology Centers /ID# 275374
Marietta, Georgia 30060
United States
Memorial University Medical Center /ID# 272467
Savannah, Georgia 31404
United States
Kaiser Permanente Moanalua Medical Center /ID# 272916
Honolulu, Hawaii 96819
United States
University of Illinois Hospital and Health Sciences System /ID# 275345
Chicago, Illinois 60607
United States
Illinois Cancer Specialists /ID# 274678
Niles, Illinois 60714
United States
Springfield Clinic - First /ID# 272576
Springfield, Illinois 62702
United States
Nebraska Hematology-Oncology /ID# 272970
Lincoln, Nebraska 68506
United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527
Omaha, Nebraska 68130
United States
Renown Regional Medical Center /ID# 273535
Reno, Nevada 89502
United States
Astera Cancer Care /ID# 272359
East Brunswick, New Jersey 08816-4096
United States
Regional Cancer Care Associates /ID# 270783
Teaneck, New Jersey 07666
United States
Montefiore Medical Center - Einstein Campus /ID# 277169
The Bronx, New York 10461
United States
Clinical Research Alliance - Westbury /ID# 270455
Westbury, New York 11590
United States
FirstHealth of the Carolinas- Speciality Center /ID# 272924
Pinehurst, North Carolina 28374
United States
Mercy Health - Perrysburg Cancer Center /ID# 270536
Perrysburg, Ohio 43551
United States
Genesis Healthcare System /ID# 273361
Zanesville, Ohio 43701
United States
Guthrie Robert Packer Hospital /ID# 270316
Sayre, Pennsylvania 18840
United States
Cancer Care Associates Of York /ID# 270971
York, Pennsylvania 17403
United States
Medical University of South Carolina /ID# 273272
Charleston, South Carolina 29425
United States
Saint Francis Cancer Center - Greenville /ID# 276368
Greenville, South Carolina 29607
United States
SCRI Oncology Partners /ID# 270162
Nashville, Tennessee 37203
United States
Texas Oncology - Dallas - Worth Street /ID# 278947
Dallas, Texas 75246
United States
Texas Oncology - Northeast Texas /ID# 272000
Tyler, Texas 75702
United States
Community Cancer Trials Of Utah /ID# 276598
Ogden, Utah 84405
United States
University of Virginia /ID# 284472
Charlottesville, Virginia 22908
United States
Virginia Cancer Specialists - Fairfax /ID# 272004
Fairfax, Virginia 22031
United States
Medical Oncology Associates - Spokane /ID# 277172
Spokane, Washington 99208
United States
Northwest Medical Specialties Tacoma /ID# 270534
Tacoma, Washington 98405
United States
Suporte Nutricional e Quimioterapia LTDA - PRONUTRIR /ID# 273203
Fortaleza, Ceará 60810-180
Brazil
Ictrials Pesquisa E Desenvolvimento /ID# 276681
Curitiba, Paraná 80510-130
Brazil
Hospital De Câncer De Pernambuco /ID# 276104
Recife, Pernambuco 50040-000
Brazil
Liga Norte Riograndense Contra O Cancer /ID# 273183
Natal, Rio Grande do Norte 59075-740
Brazil
Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 272513
Ijuí, Rio Grande do Sul 98700-000
Brazil
Cepen - Centro De Pesquisa E Ensino Em Oncologia De Santa Catarina /ID# 273204
Florianópolis, Santa Catarina 88020-210
Brazil
Hospital Alemao Oswaldo Cruz - Sao Paulo /ID# 272512
São Paulo, 01323-020
Brazil
Beijing Chest Tumor Hospital /ID# 271935
Beijing, Beijing Municipality 101149
China
Fujian Province Cancer Hospital /ID# 276178
Fuzhou, Fujian 350014
China
Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931
Nanning, Guangxi 530021
China
Harbin Medical University Cancer Hospital /ID# 271665
Harbin, Heilongjiang 150081
China
Henan Cancer Hospital /ID# 271927
Zhengzhou, Henan 450008
China
Union Hospital - Tongji Medical College /ID# 271668
Wuhan, Hubei 430022
China
The First Affiliated Hospital of Nanchang University /ID# 271666
Nanchang, Jiangxi 330006
China
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271928
Xi'an, Shaanxi 710061
China
LinYi Cancer Hospital /ID# 272068
Linyi, Shandong 276001
China
Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933
Ürümqi, Xinjiang 830011
China
Meir Medical Center /ID# 270071
Kefar Sava, Central District 4428164
Israel
Rabin Medical Center. /ID# 270087
Petah Tikva, Central District 4941492
Israel
The Chaim Sheba Medical Center /ID# 270068
Ramat Gan, Tel Aviv 5265601
Israel
Rambam Health Care Campus- Haifa /ID# 270078
Haifa, 3109601
Israel
Shaare Zedek Medical Center /ID# 270095
Jerusalem, 9103102
Israel
Nagoya University Hospital /ID# 277010
Nagoya, Aichi-ken 466-8560
Japan
National Cancer Center Hospital East /ID# 277056
Kashiwa-shi, Chiba 277-8577
Japan
Hokkaido University Hospital /ID# 277014
Sapporo, Hokkaido 060-8648
Japan
Kobe Minimally Invasive Cancer Center /ID# 277469
Kobe, Hyōgo 650-0046
Japan
Kitasato University Hospital /ID# 277012
Sagamihara-shi, Kanagawa 252-0375
Japan
Sendai Kousei Hospital /ID# 277023
Sendai, Miyagi 981-0914
Japan
University of Miyazaki Hospital /ID# 277020
Miyazaki, Miyazaki 889-1692
Japan
Kurashiki Central Hospital /ID# 276995
Kurashiki-shi, Okayama-ken 710-8602
Japan
Fujieda Municipal General Hospital /ID# 277025
Fujieda, Shizuoka 426-0077
Japan
Wakayama Medical University Hospital /ID# 276997
Wakayama, Wakayama 641-8510
Japan
Institute for Oncology and Radiology of Serbia /ID# 270561
Belgrade, Beograd 11000
Serbia
Military Medical Academy /ID# 279873
Belgrade, Beograd 11000
Serbia
University Clinical Center Serbia /ID# 270808
Belgrade, Beograd 11000
Serbia
Clinical Hospital Center - Bezanijska Kosa /ID# 270558
Belgrade, Beograd 11080
Serbia
University Clinical Center Nis /ID# 270557
Niš, Nisavski Okrug 18300
Serbia
Institute For Pulmonary Diseases Of Vojvodina /ID# 270559
Kamenitz, Sremski Okrug 21208
Serbia
University Clinical Center Kragujevac /ID# 275773
Kragujevac, Sumadijski Okrug 34000
Serbia
National Cancer Centre Singapore /ID# 271499
Singapore, Central Singapore 169611
Singapore
National University Hospital /ID# 271700
Singapore, 119074
Singapore