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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
January 20, 2025
Primary Completion Date
February 1, 2028
Completion Date
February 1, 2028
Last Updated
February 23, 2026
150
ESTIMATED participants
Telisotuzumab Vedotin
DRUG
Lead Sponsor
AbbVie
NCT06305754
NCT07190248
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07100080