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)
NCT ID: NCT06568939
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2025-01-20
2028-02-29
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Telisotuzumab Vedotin Dose C
Participants will receive telisotuzumab vedotin dose C, as part of the 3 year study duration.
Telisotuzumab Vedotin
Intravenous (IV) Infusion
Telisotuzumab Vedotin Dose A
Participants will receive telisotuzumab vedotin dose A, as part of the 3 year study duration.
Telisotuzumab Vedotin
Intravenous (IV) Infusion
Telisotuzumab Vedotin Dose B
Participants will receive telisotuzumab vedotin dose B, as part of the 3 year study duration.
Telisotuzumab Vedotin
Intravenous (IV) Infusion
Interventions
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Telisotuzumab Vedotin
Intravenous (IV) Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Actionable EGFR activating mutations.
* Received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E.
* Received prior docetaxel therapy.
* Metastases to the central nervous system (CNS). Participants with CNS metastases are eligible only after adequate treatment (such as surgery or, radiotherapy, or drug therapy) is provided, as stated on the protocol.
* History of other malignancies except those stated in the protocol.
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan, as noted in the protocol.
* Unresolved clinically significant adverse event (AE) \>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
* Major surgery within 21 days prior to randomization.
* Clinically significant condition(s) including but not limited to those listed in the protocol.
* Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis.
* Grade \>= 2 edema or lymphedema.
* Grade \>= 2 ascites or pleural effusion.
* Grade \>= 2 neuropathy.
* Active uncontrolled bacterial or viral infection.
* Active corneal disorder.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Ironwood Cancer & Research Center /ID# 276370
Chandler, Arizona, 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
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
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 Hospital, Capital Medical University /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 /ID# 270078
Haifa, , Israel
Shaare Zedek Medical Center /ID# 270095
Jerusalem, , Israel
Rabin Medical Center. /ID# 270087
Petah Tikva, , Israel
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
Fujieda Municipal General Hospital /ID# 277025
Fujieda, Shizuoka, 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
Countries
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Central Contacts
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Related Links
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Other Identifiers
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M25-274
Identifier Type: -
Identifier Source: org_study_id