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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)

NCT06568939 · AbbVie
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Official title
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
About this study
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 80 to 90 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 criteria
Inclusion Criteria: * Projected life expectancy of at least 12 weeks. * Must have c-Met overexpressing non-small cell lung cancer (NSCLC) (defined as \>= 25% tumor cells with 3+ staining (high \[\>= 50% 3+\]; intermediate \[\>= 25% - \< 50%\]) as assessed by a Sponsor 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: * Adenosquamous or neuroendocrine histology, or sarcomatoid features. * EGFR activating mutations (e.g., EGFR Exon 19 deletions, T790M, Exon 21 L858R, or Exon 20 insertion 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.
Study design
Enrollment target: 150 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-01-20
Estimated completion: 2028-02
Last updated: 2026-07-06
Interventions
Drug: Telisotuzumab Vedotin
Primary outcomes
  • Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2) (Up to Approximately 3 Years)
  • Percentage of Participants with Treatment-Emergent Interstitial Lung Disease (ILD) (Up to Approximately 3 Years)
  • Percentage of Participants with Treatment-Emergent Peripheral Neuropathy (Up to Approximately 3 Years)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (78)
Ironwood Cancer and Research Center /ID# 276370Recruiting
Chandler, Arizona, United States
University of Arkansas for Medical Sciences /ID# 272923Recruiting
Little Rock, Arkansas, United States
Valkyrie Clinical Trials /ID# 271322Recruiting
Los Angeles, California, United States
Yale New Haven Hospital /ID# 271584Recruiting
New Haven, Connecticut, United States
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899Recruiting
Jacksonville, Florida, United States
Ocala Oncology Center /ID# 273697Recruiting
Ocala, Florida, United States
Memorial Hospital West /ID# 270313Recruiting
Pembroke Pines, Florida, United States
Comprehensive Hematology Oncology /ID# 270422Recruiting
St. Petersburg, Florida, United States
Florida Cancer Specialists - North /ID# 271995Recruiting
St. Petersburg, Florida, United States
Florida Cancer Specialists - East /ID# 271993Recruiting
West Palm Beach, Florida, United States
University Cancer & Blood Center /ID# 270969Recruiting
Athens, Georgia, United States
Northwest Georgia Oncology Centers /ID# 275374Recruiting
Marietta, Georgia, United States
Memorial University Medical Center /ID# 272467Recruiting
Savannah, Georgia, United States
Kaiser Permanente Moanalua Medical Center /ID# 272916Recruiting
Honolulu, Hawaii, United States
University of Illinois Hospital and Health Sciences System /ID# 275345Recruiting
Chicago, Illinois, United States
Illinois Cancer Specialists /ID# 274678Recruiting
Niles, Illinois, United States
Springfield Clinic - First /ID# 272576Recruiting
Springfield, Illinois, United States
Nebraska Hematology-Oncology /ID# 272970Recruiting
Lincoln, Nebraska, United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527Recruiting
Omaha, Nebraska, United States
Renown Regional Medical Center /ID# 273535Recruiting
Reno, Nevada, United States
Astera Cancer Care /ID# 272359Recruiting
East Brunswick, New Jersey, United States
Regional Cancer Care Associates /ID# 270783Recruiting
Teaneck, New Jersey, United States
Montefiore Medical Center - Einstein Campus /ID# 277169Recruiting
The Bronx, New York, United States
Clinical Research Alliance - Westbury /ID# 270455Recruiting
Westbury, New York, United States
FirstHealth of the Carolinas- Speciality Center /ID# 272924Recruiting
Pinehurst, North Carolina, United States
Mercy Health - Perrysburg Cancer Center /ID# 270536Recruiting
Perrysburg, Ohio, United States
Genesis Healthcare System /ID# 273361Recruiting
Zanesville, Ohio, United States
Guthrie Robert Packer Hospital /ID# 270316Recruiting
Sayre, Pennsylvania, United States
Cancer Care Associates Of York /ID# 270971Recruiting
York, Pennsylvania, United States
Medical University of South Carolina /ID# 273272Recruiting
Charleston, South Carolina, United States
Saint Francis Cancer Center - Greenville /ID# 276368Recruiting
Greenville, South Carolina, United States
SCRI Oncology Partners /ID# 270162Recruiting
Nashville, Tennessee, United States
Texas Oncology - Dallas - Worth Street /ID# 278947Recruiting
Dallas, Texas, United States
Texas Oncology - Northeast Texas /ID# 272000Recruiting
Tyler, Texas, United States
Community Cancer Trials Of Utah /ID# 276598Recruiting
Ogden, Utah, United States
Virginia Cancer Specialists - Fairfax /ID# 272004Recruiting
Fairfax, Virginia, United States
Medical Oncology Associates - Spokane /ID# 277172Recruiting
Spokane, Washington, United States
Northwest Medical Specialties Tacoma /ID# 270534Recruiting
Tacoma, Washington, United States
Suporte Nutricional e Quimioterapia LTDA - PRONUTRIR /ID# 273203Recruiting
Fortaleza, Ceará, Brazil
Ictrials Pesquisa E Desenvolvimento /ID# 276681Recruiting
Curitiba, Paraná, Brazil
Hospital De Câncer De Pernambuco /ID# 276104Recruiting
Recife, Pernambuco, Brazil
Liga Norte Riograndense Contra O Cancer /ID# 273183Recruiting
Natal, Rio Grande do Norte, Brazil
Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 272513Recruiting
Ijuí, Rio Grande do Sul, Brazil
Hospital Alemao Oswaldo Cruz - Sao Paulo /ID# 272512Recruiting
São Paulo, Brazil
Beijing Chest Tumor Hospital /ID# 271935Recruiting
Beijing, Beijing Municipality, China
Fujian Province Cancer Hospital /ID# 276178Recruiting
Fuzhou, Fujian, China
Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931Recruiting
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital /ID# 271665Recruiting
Harbin, Heilongjiang, China
Henan Cancer Hospital /ID# 271927Recruiting
Zhengzhou, Henan, China
Union Hospital - Tongji Medical College /ID# 271668Recruiting
Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University /ID# 271666Recruiting
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271928Recruiting
Xi'an, Shaanxi, China
LinYi Cancer Hospital /ID# 272068Recruiting
Linyi, Shandong, China
Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933Recruiting
Ürümqi, Xinjiang, China
Meir Medical Center /ID# 270071Recruiting
Kefar Sava, Central District, Israel
Rabin Medical Center. /ID# 270087Recruiting
Petah Tikva, Central District, Israel
The Chaim Sheba Medical Center /ID# 270068Recruiting
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus- Haifa /ID# 270078Recruiting
Haifa, Israel
Shaare Zedek Medical Center /ID# 270095Completed
Jerusalem, Israel
Nagoya University Hospital /ID# 277010Recruiting
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 277056Recruiting
Kashiwa-shi, Chiba, Japan
Hokkaido University Hospital /ID# 277014Recruiting
Sapporo, Hokkaido, Japan
Kobe Minimally Invasive Cancer Center /ID# 277469Recruiting
Kobe, Hyōgo, Japan
Kitasato University Hospital /ID# 277012Recruiting
Sagamihara-shi, Kanagawa, Japan
Sendai Kousei Hospital /ID# 277023Recruiting
Sendai, Miyagi, Japan
University of Miyazaki Hospital /ID# 277020Recruiting
Miyazaki, Miyazaki, Japan
Kurashiki Central Hospital /ID# 276995Recruiting
Kurashiki-shi, Okayama-ken, Japan
Fujieda Municipal General Hospital /ID# 277025Recruiting
Fujieda, Shizuoka, Japan
Wakayama Medical University Hospital /ID# 276997Recruiting
Wakayama, Wakayama, Japan
Institute for Oncology and Radiology of Serbia /ID# 270561Recruiting
Belgrade, Beograd, Serbia
Military Medical Academy /ID# 279873Recruiting
Belgrade, Beograd, Serbia
University Clinical Center Serbia /ID# 270808Recruiting
Belgrade, Beograd, Serbia
Clinical Hospital Center - Bežanijska Kosa /ID# 270558Recruiting
Belgrade, Beograd, Serbia
University Clinical Center Nis /ID# 270557Recruiting
Niš, Nisavski Okrug, Serbia
Institute For Pulmonary Diseases Of Vojvodina /ID# 270559Recruiting
Kamenitz, Sremski Okrug, Serbia
University Clinical Center Kragujevac /ID# 275773Recruiting
Kragujevac, Sumadijski Okrug, Serbia
National Cancer Centre Singapore /ID# 271499Recruiting
Singapore, Central Singapore, Singapore
National University Hospital /ID# 271700Recruiting
Singapore, Singapore
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) · TrialPath