Actively Recruiting
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)
Led by AbbVie · Updated on 2026-02-23
150
Participants Needed
64
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Projected life expectancy of at least 12 weeks
- Confirmed c-Met overexpressing non-small cell lung cancer (NSCLC) by designated laboratory
- Histologically or cytologically documented locally advanced or metastatic NSCLC
- Known epidermal growth factor receptor (EGFR) activating mutation status
- Actionable gene alterations other than EGFR allowed
- Measurable disease per RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Received no more than 1 prior line of systemic cytotoxic chemotherapy for advanced disease
- Progressed on at least 1 prior therapy for locally advanced/metastatic NSCLC
You will not qualify if you...
- Adenosquamous or neuroendocrine histology, or sarcomatoid features
- Presence of actionable EGFR activating mutations
- Prior treatment with c-Met-targeted antibodies or telisotuzumab vedotin or related antibody-drug conjugates
- Prior docetaxel therapy
- Metastases to the central nervous system unless adequately treated
- History of other malignancies except as specified in protocol
- History or presence of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or active pneumonitis
- Unresolved clinically significant adverse events Grade 2 or higher from prior cancer therapy except alopecia or anemia
- Major surgery within 21 days before randomization
- Clinically significant conditions including severe liver disease, active infections, Grade 2 or higher edema, ascites, neuropathy, or active corneal disorder
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Trial Site Locations
Total: 64 locations
1
Ironwood Cancer & Research Center /ID# 276370
Chandler, Arizona, United States, 85224
Actively Recruiting
2
University of Arkansas for Medical Sciences /ID# 272923
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Valkyrie Clinical Trials /ID# 271322
Los Angeles, California, United States, 90067
Actively Recruiting
4
Yale New Haven Hospital /ID# 271584
New Haven, Connecticut, United States, 06510
Actively Recruiting
5
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899
Jacksonville, Florida, United States, 32256
Actively Recruiting
6
Ocala Oncology Center /ID# 273697
Ocala, Florida, United States, 34474
Actively Recruiting
7
Comprehensive Hematology Oncology /ID# 270422
St. Petersburg, Florida, United States, 33701-4732
Actively Recruiting
8
Florida Cancer Specialists - North /ID# 271995
St. Petersburg, Florida, United States, 33705
Actively Recruiting
9
Florida Cancer Specialists - East /ID# 271993
West Palm Beach, Florida, United States, 33401
Actively Recruiting
10
University Cancer & Blood Center /ID# 270969
Athens, Georgia, United States, 30607
Actively Recruiting
11
Northwest Georgia Oncology Centers /ID# 275374
Marietta, Georgia, United States, 30060
Actively Recruiting
12
Memorial University Medical Center /ID# 272467
Savannah, Georgia, United States, 31404
Actively Recruiting
13
Kaiser Permanente Moanalua Medical Center /ID# 272916
Honolulu, Hawaii, United States, 96819
Actively Recruiting
14
University of Illinois Hospital and Health Sciences System /ID# 275345
Chicago, Illinois, United States, 60607
Actively Recruiting
15
Illinois Cancer Specialists /ID# 274678
Niles, Illinois, United States, 60714
Actively Recruiting
16
Springfield Clinic - First /ID# 272576
Springfield, Illinois, United States, 62702
Actively Recruiting
17
NHO - Nebraska Hematology-Oncology /ID# 272970
Lincoln, Nebraska, United States, 68506
Actively Recruiting
18
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527
Omaha, Nebraska, United States, 68130
Actively Recruiting
19
Renown Regional Medical Center /ID# 273535
Reno, Nevada, United States, 89502
Actively Recruiting
20
Astera Cancer Care /ID# 272359
East Brunswick, New Jersey, United States, 08816-4096
Actively Recruiting
21
Montefiore Medical Center /ID# 277169
The Bronx, New York, United States, 10461
Actively Recruiting
22
Clinical Research Alliance - Westbury /ID# 270455
Westbury, New York, United States, 11590
Actively Recruiting
23
FirstHealth of the Carolinas- Speciality Center /ID# 272924
Pinehurst, North Carolina, United States, 28374
Actively Recruiting
24
Mercy Health - Perrysburg Cancer Center /ID# 270536
Perrysburg, Ohio, United States, 43551
Actively Recruiting
25
Genesis Healthcare System /ID# 273361
Zanesville, Ohio, United States, 43701
Actively Recruiting
26
Guthrie Robert Packer Hospital /ID# 270316
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
27
Cancer Care Associates Of York /ID# 270971
York, Pennsylvania, United States, 17403
Actively Recruiting
28
Medical University of South Carolina /ID# 273272
Charleston, South Carolina, United States, 29425
Actively Recruiting
29
Saint Francis Cancer Center - Greenville /ID# 276368
Greenville, South Carolina, United States, 29607
Actively Recruiting
30
SCRI Oncology Partners /ID# 270162
Nashville, Tennessee, United States, 37203
Actively Recruiting
31
Texas Oncology - Northeast Texas /ID# 272000
Tyler, Texas, United States, 75702
Actively Recruiting
32
Community Cancer Trials Of Utah /ID# 276598
Ogden, Utah, United States, 84405
Actively Recruiting
33
Virginia Cancer Specialists - Fairfax /ID# 272004
Fairfax, Virginia, United States, 22031
Actively Recruiting
34
Medical Oncology Associates - Spokane /ID# 277172
Spokane, Washington, United States, 99208
Actively Recruiting
35
Northwest Medical Specialties Tacoma /ID# 270534
Tacoma, Washington, United States, 98405
Actively Recruiting
36
Beijing Chest Tumor Hospital /ID# 271935
Beijing, Beijing Municipality, China, 101149
Actively Recruiting
37
Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931
Nanning, Guangxi, China, 530021
Actively Recruiting
38
Henan Cancer Hospital /ID# 271927
Zhengzhou, Henan, China, 450008
Actively Recruiting
39
Union Hospital - Tongji Medical College /ID# 271668
Wuhan, Hubei, China, 430022
Actively Recruiting
40
The First Affiliated Hospital of Nanchang University /ID# 271666
Nanchang, Jiangxi, China, 330006
Actively Recruiting
41
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271928
Xi'an, Shaanxi, China, 710061
Actively Recruiting
42
Linyi Cancer Hospital /ID# 272068
Linyi, Shandong, China, 276034
Actively Recruiting
43
Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933
Ürümqi, Xinjiang, China, 830011
Actively Recruiting
44
Meir Medical Center /ID# 270071
Kfar Saba, Central District, Israel, 4428164
Actively Recruiting
45
Rambam Health Care Campus- Haifa /ID# 270078
Haifa, Israel, 3525408
Actively Recruiting
46
Shaare Zedek Medical Center /ID# 270095
Jerusalem, Israel, 9103102
Completed
47
Rabin Medical Center. /ID# 270087
Petah Tikva, Israel, 4941492
Actively Recruiting
48
Nagoya University Hospital /ID# 277010
Nagoya, Aichi-ken, Japan, 466-8560
Actively Recruiting
49
Hokkaido University Hospital /ID# 277014
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
50
Kobe Minimally Invasive Cancer Center /ID# 277469
Kobe, Hyōgo, Japan, 650-0046
Actively Recruiting
51
Kitasato University Hospital /ID# 277012
Sagamihara-shi, Kanagawa, Japan, 252-0375
Actively Recruiting
52
Sendai Kousei Hospital /ID# 277023
Sendai, Miyagi, Japan, 981-0914
Actively Recruiting
53
University of Miyazaki Hospital /ID# 277020
Miyazaki, Miyazaki, Japan, 889-1692
Actively Recruiting
54
Kurashiki Central Hospital /ID# 276995
Kurashiki-shi, Okayama-ken, Japan, 710-8602
Actively Recruiting
55
Fujieda Municipal General Hospital /ID# 277025
Fujieda, Shizuoka, Japan, 426-0077
Actively Recruiting
56
Wakayama Medical University Hospital /ID# 276997
Wakayama, Wakayama, Japan, 641-8510
Actively Recruiting
57
Institute for Oncology and Radiology of Serbia /ID# 270561
Belgrade, Beograd, Serbia, 11000
Actively Recruiting
58
University Clinical Center Serbia /ID# 270808
Belgrade, Beograd, Serbia, 11000
Actively Recruiting
59
Clinical Hospital Center - Bežanijska Kosa /ID# 270558
Belgrade, Beograd, Serbia, 11080
Actively Recruiting
60
University Clinical Center Nis /ID# 270557
Niš, Nisavski Okrug, Serbia, 18300
Actively Recruiting
61
Institute For Pulmonary Diseases Of Vojvodina /ID# 270559
Kamenitz, Sremski Okrug, Serbia, 21208
Actively Recruiting
62
University Clinical Center Kragujevac /ID# 275773
Kragujevac, Sumadijski Okrug, Serbia, 34000
Actively Recruiting
63
National Cancer Centre Singapore /ID# 271499
Singapore, Central Singapore, Singapore, 169611
Actively Recruiting
64
National University Hospital /ID# 271700
Singapore, Singapore, 119074
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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