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
Status: Recruiting
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Projected life expectancy of at least 12 weeks.
• Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory
• Must have histologically or cytologically documented NSCLC that is locally advanced or metastatic.
• Must have a known epidermal growth factor receptor (EGFR) activating mutation status.
• Actionable alterations in genes other than EGFR are permitted.
• Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
• Must have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting, as stated in the protocol.
• Must have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC, as stated in the protocol.
Locations
United States
Arizona
Ironwood Cancer & Research Center /ID# 276370
RECRUITING
Chandler
California
Valkyrie Clinical Trials /ID# 271322
RECRUITING
Los Angeles
Connecticut
Yale New Haven Hospital /ID# 271584
RECRUITING
New Haven
Florida
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899
RECRUITING
Jacksonville
Ocala Oncology Center /ID# 273697
RECRUITING
Ocala
Comprehensive Hematology Oncology /ID# 270422
RECRUITING
St. Petersburg
Florida Cancer Specialists - North /ID# 271995
RECRUITING
St. Petersburg
Florida Cancer Specialists - East /ID# 271993
RECRUITING
West Palm Beach
Georgia
University Cancer & Blood Center /ID# 270969
RECRUITING
Athens
Memorial University Medical Center /ID# 272467
RECRUITING
Savannah
Illinois
Springfield Clinic - First /ID# 272576
RECRUITING
Springfield
North Carolina
FirstHealth of the Carolinas- Speciality Center /ID# 272924
RECRUITING
Pinehurst
Nebraska
NHO - Nebraska Hematology-Oncology /ID# 272970
RECRUITING
Lincoln
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527
RECRUITING
Omaha
New Jersey
Astera Cancer Care /ID# 272359
RECRUITING
East Brunswick
Nevada
Renown Regional Medical Center /ID# 273535
RECRUITING
Reno
New York
Clinical Research Alliance - Westbury /ID# 270455
RECRUITING
Westbury
Ohio
Mercy Health - Perrysburg Cancer Center /ID# 270536
RECRUITING
Perrysburg
Genesis Healthcare System /ID# 273361
RECRUITING
Zanesville
Pennsylvania
Guthrie Robert Packer Hospital /ID# 270316
RECRUITING
Sayre
Cancer Care Associates Of York /ID# 270971
RECRUITING
York
Tennessee
SCRI Oncology Partners /ID# 270162
RECRUITING
Nashville
Texas
Texas Oncology - Northeast Texas /ID# 272000
RECRUITING
Tyler
Virginia
Virginia Cancer Specialists - Fairfax /ID# 272004
RECRUITING
Fairfax
Washington
Northwest Medical Specialties Tacoma /ID# 270534
RECRUITING
Tacoma
Other Locations
China
Beijing Chest Hospital, Capital Medical University /ID# 271935
RECRUITING
Beijing
Linyi Cancer Hospital /ID# 272068
RECRUITING
Linyi
The First Affiliated Hospital of Nanchang University /ID# 271666
RECRUITING
Nanchang
Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931
RECRUITING
Nanning
Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933
RECRUITING
Ürümqi
Union Hospital - Tongji Medical College /ID# 271668
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271928
RECRUITING
Xi'an
Israel
Rambam Health Care Campus /ID# 270078
RECRUITING
Haifa
Shaare Zedek Medical Center /ID# 270095
RECRUITING
Jerusalem
Meir Medical Center /ID# 270071
RECRUITING
Kfar Saba
Rabin Medical Center /ID# 270087
RECRUITING
Petah Tikva
Serbia
Clinical Hospital Center - Bežanijska Kosa /ID# 270558
RECRUITING
Belgrade
Institute for Oncology and Radiology of Serbia /ID# 270561
RECRUITING
Belgrade
University Clinical Center Serbia /ID# 270808
RECRUITING
Belgrade
Institute For Pulmonary Diseases Of Vojvodina /ID# 270559
RECRUITING
Kamenitz
University Clinical Center Kragujevac /ID# 275773
RECRUITING
Kragujevac
Singapore
National Cancer Centre Singapore /ID# 271499
RECRUITING
Singapore
National University Hospital /ID# 271700
RECRUITING
Singapore
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date:2025-01-20
Estimated Completion Date:2028-02
Participants
Target number of participants:150
Treatments
Experimental: Telisotuzumab Vedotin Dose A
Participants will receive telisotuzumab vedotin dose A, as part of the 3 year study duration.
Experimental: Telisotuzumab Vedotin Dose B
Participants will receive telisotuzumab vedotin dose B, as part of the 3 year study duration.
Experimental: Telisotuzumab Vedotin Dose C
Participants will receive telisotuzumab vedotin dose C, as part of the 3 year study duration.
Who is this study for: Patients with previously treated c-met overexpressing, EGFR wildtype, locally advanced/metastatic non-squamous non-small cell lung cancer