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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)
Sponsor: AbbVie
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 70 to 80 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.
Official title: A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-01-20
Completion Date
2028-02
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
Telisotuzumab Vedotin
Intravenous (IV) Infusion
Locations (64)
Ironwood Cancer & Research Center /ID# 276370
Chandler, Arizona, United States
University of Arkansas for Medical Sciences /ID# 272923
Little Rock, Arkansas, United States
Valkyrie Clinical Trials /ID# 271322
Los Angeles, California, United States
Yale New Haven Hospital /ID# 271584
New Haven, Connecticut, United States
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899
Jacksonville, Florida, United States
Ocala Oncology Center /ID# 273697
Ocala, Florida, United States
Comprehensive Hematology Oncology /ID# 270422
St. Petersburg, Florida, United States
Florida Cancer Specialists - North /ID# 271995
St. Petersburg, Florida, United States
Florida Cancer Specialists - East /ID# 271993
West Palm Beach, Florida, United States
University Cancer & Blood Center /ID# 270969
Athens, Georgia, United States
Northwest Georgia Oncology Centers /ID# 275374
Marietta, Georgia, United States
Memorial University Medical Center /ID# 272467
Savannah, Georgia, United States
Kaiser Permanente Moanalua Medical Center /ID# 272916
Honolulu, Hawaii, United States
University of Illinois Hospital and Health Sciences System /ID# 275345
Chicago, Illinois, United States
Illinois Cancer Specialists /ID# 274678
Niles, Illinois, United States
Springfield Clinic - First /ID# 272576
Springfield, Illinois, United States
NHO - Nebraska Hematology-Oncology /ID# 272970
Lincoln, Nebraska, United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527
Omaha, Nebraska, United States
Renown Regional Medical Center /ID# 273535
Reno, Nevada, United States
Astera Cancer Care /ID# 272359
East Brunswick, New Jersey, United States
Montefiore Medical Center /ID# 277169
The Bronx, New York, United States
Clinical Research Alliance - Westbury /ID# 270455
Westbury, New York, United States
FirstHealth of the Carolinas- Speciality Center /ID# 272924
Pinehurst, North Carolina, United States
Mercy Health - Perrysburg Cancer Center /ID# 270536
Perrysburg, Ohio, United States
Genesis Healthcare System /ID# 273361
Zanesville, Ohio, United States
Guthrie Robert Packer Hospital /ID# 270316
Sayre, Pennsylvania, United States
Cancer Care Associates Of York /ID# 270971
York, Pennsylvania, United States
Medical University of South Carolina /ID# 273272
Charleston, South Carolina, United States
Saint Francis Cancer Center - Greenville /ID# 276368
Greenville, South Carolina, United States
SCRI Oncology Partners /ID# 270162
Nashville, Tennessee, United States
Texas Oncology - Northeast Texas /ID# 272000
Tyler, Texas, United States
Community Cancer Trials Of Utah /ID# 276598
Ogden, Utah, United States
Virginia Cancer Specialists - Fairfax /ID# 272004
Fairfax, Virginia, United States
Medical Oncology Associates - Spokane /ID# 277172
Spokane, Washington, United States
Northwest Medical Specialties Tacoma /ID# 270534
Tacoma, Washington, United States
Beijing Chest Tumor Hospital /ID# 271935
Beijing, Beijing Municipality, China
Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931
Nanning, Guangxi, China
Henan Cancer Hospital /ID# 271927
Zhengzhou, Henan, China
Union Hospital - Tongji Medical College /ID# 271668
Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University /ID# 271666
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271928
Xi'an, Shaanxi, China
Linyi Cancer Hospital /ID# 272068
Linyi, Shandong, China
Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933
Ürümqi, Xinjiang, China
Meir Medical Center /ID# 270071
Kfar Saba, Central District, Israel
Rambam Health Care Campus- Haifa /ID# 270078
Haifa, Israel
Shaare Zedek Medical Center /ID# 270095
Jerusalem, Israel
Rabin Medical Center. /ID# 270087
Petah Tikva, Israel
Nagoya University Hospital /ID# 277010
Nagoya, Aichi-ken, Japan
Hokkaido University Hospital /ID# 277014
Sapporo, Hokkaido, Japan
Kobe Minimally Invasive Cancer Center /ID# 277469
Kobe, Hyōgo, Japan
Kitasato University Hospital /ID# 277012
Sagamihara-shi, Kanagawa, Japan
Sendai Kousei Hospital /ID# 277023
Sendai, Miyagi, Japan
University of Miyazaki Hospital /ID# 277020
Miyazaki, Miyazaki, Japan
Kurashiki Central Hospital /ID# 276995
Kurashiki-shi, Okayama-ken, Japan
Fujieda Municipal General Hospital /ID# 277025
Fujieda, Shizuoka, Japan
Wakayama Medical University Hospital /ID# 276997
Wakayama, Wakayama, Japan
Institute for Oncology and Radiology of Serbia /ID# 270561
Belgrade, Beograd, Serbia
University Clinical Center Serbia /ID# 270808
Belgrade, Beograd, Serbia
Clinical Hospital Center - Bežanijska Kosa /ID# 270558
Belgrade, Beograd, Serbia
University Clinical Center Nis /ID# 270557
Niš, Nisavski Okrug, Serbia
Institute For Pulmonary Diseases Of Vojvodina /ID# 270559
Kamenitz, Sremski Okrug, Serbia
University Clinical Center Kragujevac /ID# 275773
Kragujevac, Sumadijski Okrug, Serbia
National Cancer Centre Singapore /ID# 271499
Singapore, Central Singapore, Singapore
National University Hospital /ID# 271700
Singapore, Singapore