Actively Recruiting
A Phase 2, Open-Label, Randomized Study of Three Telisotuzumab Vedotin Doses in Adults With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced or Metastatic Non-Squamous NSCLC
Led by AbbVie · Updated on 2026-06-05
150
Participants Needed
72
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Non-small cell lung cancer (NSCLC) is a condition where cancer cells grow uncontrollably in lung tissues. This trial evaluates the safety and effects of telisotuzumab vedotin, an investigational drug, in adults with NSCLC that overexpresses c-Met. The study focuses on changes in disease activity and treatment side effects in participants previously treated for this cancer type. Participants will be randomly assigned to one of three groups, each receiving a different dose of telisotuzumab vedotin through intravenous infusion. The study lasts about three years, during which participants receive the assigned dose regularly. The trial is open-label and conducted globally, involving approximately 150 adults who have specific tumor characteristics and prior treatment history. During the trial, participants will visit hospitals or clinics regularly for medical assessments, blood tests, and side effect monitoring. Researchers will measure safety through adverse event tracking, including lung disease, nerve problems, and eye disorders. They will also assess the drug's presence in the blood and patient-reported outcomes over the study period. The trial aims to understand the drug's safety, how it moves through the body, and its impact on cancer progression and overall survival.
CONDITIONS
Brief 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
- Diagnosed with c-Met overexpressing non-small cell lung cancer (NSCLC) confirmed by specific lab testing
- Histologically or cytologically documented NSCLC that is locally advanced or metastatic
- Known EGFR activating mutation status
- Measurable disease based on RECIST version 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Received no more than 1 line of prior systemic cytotoxic chemotherapy for advanced or metastatic NSCLC
- Progressed on at least 1 prior therapy for locally advanced or metastatic NSCLC
You will not qualify if you...
- Adenosquamous, neuroendocrine histology, or sarcomatoid features
- Presence of EGFR activating mutations such as Exon 19 deletions, T790M, Exon 21 L858R, or Exon 20 insertion mutations
- Prior treatment with c-Met-targeted antibodies, telisotuzumab vedotin, or related antibody-drug conjugates
- Prior docetaxel therapy
- Metastases to the central nervous system unless adequately treated
- History of other cancers not allowed by protocol
- History or evidence of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or active pneumonitis on screening CT scan
- Unresolved significant adverse events from prior cancer therapy except alopecia or anemia
- Major surgery within 21 days before randomization
- Clinically significant conditions as detailed in the protocol
- Significant liver disease including hepatitis, alcohol abuse, or cirrhosis
- Grade 2 or higher edema, lymphedema, ascites, or pleural effusion
- Grade 2 or higher neuropathy
- Active uncontrolled bacterial or viral infection
- Active corneal disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 years
Participants receive intravenous infusions of telisotuzumab vedotin at one of three dose levels.
Regular visits for drug infusions and assessments during treatment
Trial Site Locations
Total: 72 locations
1
Ironwood Cancer and 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
Memorial Hospital West /ID# 270313
Pembroke Pines, Florida, United States, 33028
Actively Recruiting
8
Comprehensive Hematology Oncology /ID# 270422
St. Petersburg, Florida, United States, 33701-4732
Actively Recruiting
9
Florida Cancer Specialists - North /ID# 271995
St. Petersburg, Florida, United States, 33705
Actively Recruiting
10
Florida Cancer Specialists - East /ID# 271993
West Palm Beach, Florida, United States, 33401
Actively Recruiting
11
University Cancer & Blood Center /ID# 270969
Athens, Georgia, United States, 30607
Actively Recruiting
12
Northwest Georgia Oncology Centers /ID# 275374
Marietta, Georgia, United States, 30060
Actively Recruiting
13
Memorial University Medical Center /ID# 272467
Savannah, Georgia, United States, 31404
Actively Recruiting
14
Kaiser Permanente Moanalua Medical Center /ID# 272916
Honolulu, Hawaii, United States, 96819
Actively Recruiting
15
University of Illinois Hospital and Health Sciences System /ID# 275345
Chicago, Illinois, United States, 60607
Actively Recruiting
16
Illinois Cancer Specialists /ID# 274678
Niles, Illinois, United States, 60714
Actively Recruiting
17
Springfield Clinic - First /ID# 272576
Springfield, Illinois, United States, 62702
Actively Recruiting
18
NHO - Nebraska Hematology-Oncology /ID# 272970
Lincoln, Nebraska, United States, 68506
Actively Recruiting
19
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527
Omaha, Nebraska, United States, 68130
Actively Recruiting
20
Renown Regional Medical Center /ID# 273535
Reno, Nevada, United States, 89502
Actively Recruiting
21
Astera Cancer Care /ID# 272359
East Brunswick, New Jersey, United States, 08816-4096
Actively Recruiting
22
Regional Cancer Care Associates /ID# 270783
Teaneck, New Jersey, United States, 07666
Actively Recruiting
23
Montefiore Medical Center - Einstein Campus /ID# 277169
The Bronx, New York, United States, 10461
Actively Recruiting
24
Clinical Research Alliance - Westbury /ID# 270455
Westbury, New York, United States, 11590
Actively Recruiting
25
FirstHealth of the Carolinas- Speciality Center /ID# 272924
Pinehurst, North Carolina, United States, 28374
Actively Recruiting
26
Mercy Health - Perrysburg Cancer Center /ID# 270536
Perrysburg, Ohio, United States, 43551
Actively Recruiting
27
Genesis Healthcare System /ID# 273361
Zanesville, Ohio, United States, 43701
Actively Recruiting
28
Guthrie Robert Packer Hospital /ID# 270316
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
29
Cancer Care Associates Of York /ID# 270971
York, Pennsylvania, United States, 17403
Actively Recruiting
30
Medical University of South Carolina /ID# 273272
Charleston, South Carolina, United States, 29425
Actively Recruiting
31
Saint Francis Cancer Center - Greenville /ID# 276368
Greenville, South Carolina, United States, 29607
Actively Recruiting
32
SCRI Oncology Partners /ID# 270162
Nashville, Tennessee, United States, 37203
Actively Recruiting
33
Texas Oncology - Dallas - Worth Street /ID# 278947
Dallas, Texas, United States, 75246
Actively Recruiting
34
Texas Oncology - Northeast Texas /ID# 272000
Tyler, Texas, United States, 75702
Actively Recruiting
35
Community Cancer Trials Of Utah /ID# 276598
Ogden, Utah, United States, 84405
Actively Recruiting
36
Virginia Cancer Specialists - Fairfax /ID# 272004
Fairfax, Virginia, United States, 22031
Actively Recruiting
37
Medical Oncology Associates - Spokane /ID# 277172
Spokane, Washington, United States, 99208
Actively Recruiting
38
Northwest Medical Specialties Tacoma /ID# 270534
Tacoma, Washington, United States, 98405
Actively Recruiting
39
Hospital De Câncer De Pernambuco /ID# 276104
Recife, Pernambuco, Brazil, 50040-000
Actively Recruiting
40
Liga Norte Riograndense Contra O Cancer /ID# 273183
Natal, Rio Grande do Norte, Brazil, 59075-740
Actively Recruiting
41
ONCOSITE - Centro de Pesquisa Clinica em Oncologia /ID# 272513
Ijuí, Rio Grande do Sul, Brazil, 98700-000
Actively Recruiting
42
Beijing Chest Tumor Hospital /ID# 271935
Beijing, Beijing Municipality, China, 101149
Actively Recruiting
43
Fujian Province Cancer Hospital /ID# 276178
Fuzhou, Fujian, China, 350014
Actively Recruiting
44
Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931
Nanning, Guangxi, China, 530021
Actively Recruiting
45
Henan Cancer Hospital /ID# 271927
Zhengzhou, Henan, China, 450008
Actively Recruiting
46
Union Hospital - Tongji Medical College /ID# 271668
Wuhan, Hubei, China, 430022
Actively Recruiting
47
The First Affiliated Hospital of Nanchang University /ID# 271666
Nanchang, Jiangxi, China, 330006
Actively Recruiting
48
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271928
Xi'an, Shaanxi, China, 710061
Actively Recruiting
49
LinYi Cancer Hospital /ID# 272068
Linyi, Shandong, China, 276001
Actively Recruiting
50
Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933
Ürümqi, Xinjiang, China, 830011
Actively Recruiting
51
Meir Medical Center /ID# 270071
Kefar Sava, Central District, Israel, 4428164
Actively Recruiting
52
Rabin Medical Center. /ID# 270087
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
53
Rambam Health Care Campus- Haifa /ID# 270078
Haifa, Israel, 3109601
Actively Recruiting
54
Shaare Zedek Medical Center /ID# 270095
Jerusalem, Israel, 9103102
Completed
55
Nagoya University Hospital /ID# 277010
Nagoya, Aichi-ken, Japan, 466-8560
Actively Recruiting
56
Hokkaido University Hospital /ID# 277014
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
57
Kobe Minimally Invasive Cancer Center /ID# 277469
Kobe, Hyōgo, Japan, 650-0046
Actively Recruiting
58
Kitasato University Hospital /ID# 277012
Sagamihara-shi, Kanagawa, Japan, 252-0375
Actively Recruiting
59
Sendai Kousei Hospital /ID# 277023
Sendai, Miyagi, Japan, 981-0914
Actively Recruiting
60
University of Miyazaki Hospital /ID# 277020
Miyazaki, Miyazaki, Japan, 889-1692
Actively Recruiting
61
Kurashiki Central Hospital /ID# 276995
Kurashiki-shi, Okayama-ken, Japan, 710-8602
Actively Recruiting
62
Fujieda Municipal General Hospital /ID# 277025
Fujieda, Shizuoka, Japan, 426-0077
Actively Recruiting
63
Wakayama Medical University Hospital /ID# 276997
Wakayama, Wakayama, Japan, 641-8510
Actively Recruiting
64
Institute for Oncology and Radiology of Serbia /ID# 270561
Belgrade, Beograd, Serbia, 11000
Actively Recruiting
65
Military Medical Academy /ID# 279873
Belgrade, Beograd, Serbia, 11000
Actively Recruiting
66
University Clinical Center Serbia /ID# 270808
Belgrade, Beograd, Serbia, 11000
Actively Recruiting
67
Clinical Hospital Center - Bežanijska Kosa /ID# 270558
Belgrade, Beograd, Serbia, 11080
Actively Recruiting
68
University Clinical Center Nis /ID# 270557
Niš, Nisavski Okrug, Serbia, 18300
Actively Recruiting
69
Institute For Pulmonary Diseases Of Vojvodina /ID# 270559
Kamenitz, Sremski Okrug, Serbia, 21208
Actively Recruiting
70
University Clinical Center Kragujevac /ID# 275773
Kragujevac, Sumadijski Okrug, Serbia, 34000
Actively Recruiting
71
National Cancer Centre Singapore /ID# 271499
Singapore, Central Singapore, Singapore, 169611
Actively Recruiting
72
National University Hospital /ID# 271700
Singapore, Singapore, 119074
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
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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