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NCT06568939RecruitingPhase 2

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)

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

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
150 (estimated)
First submitted
22 Aug 2024
Start date
20 Jan 2025
Primary completion date
Feb 2028
Lead sponsor
AbbVie
Diseases
Lung cancer
NCT number
NCT06568939

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 150
  • From 20 Jan 2025 to the primary completion date, Feb 2028
  • 83 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • 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.
  • 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.
  • Active uncontrolled bacterial or viral infection.
  • Active corneal disorder.

Lab values

  • EGFR activating mutations (e.g., EGFR Exon 19 deletions, T790M, Exon 21 L858R, or Exon 20 insertion mutations).

Other

  • Adenosquamous or neuroendocrine histology, or sarcomatoid features.
  • Grade \>= 2 edema or lymphedema.
  • Grade \>= 2 ascites or pleural effusion.
  • Grade \>= 2 neuropathy.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (83)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Cto - Centro De Tratamento Oncologico /ID# 276699
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BelémBrazilRecruiting
Ictrials Pesquisa E Desenvolvimento /ID# 276681
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CuritibaBrazilRecruiting
Cepen - Centro De Pesquisa E Ensino Em Oncologia De Santa Catarina /ID# 273204
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FlorianópolisBrazilRecruiting
Suporte Nutricional e Quimioterapia LTDA - PRONUTRIR /ID# 273203
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FortalezaBrazilRecruiting
Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 272513
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IjuíBrazilRecruiting
Liga Norte Riograndense Contra O Cancer /ID# 273183
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NatalBrazilRecruiting
Hospital De Cancer De Pernambuco /ID# 276104
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RecifeBrazilRecruiting
Hospital Alemao Oswaldo Cruz - Sao Paulo /ID# 272512
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São PauloBrazilRecruiting
Beijing Chest Tumor Hospital /ID# 271935
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BeijingChinaRecruiting
Fujian Province Cancer Hospital /ID# 276178
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FuzhouChinaRecruiting
Harbin Medical University Cancer Hospital /ID# 271665
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HarbinChinaRecruiting
LinYi Cancer Hospital /ID# 272068
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LinyiChinaRecruiting
The First Affiliated Hospital of Nanchang University /ID# 271666
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NanchangChinaRecruiting
Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931
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NanningChinaRecruiting
Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933
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ÜrümqiChinaRecruiting
Union Hospital - Tongji Medical College /ID# 271668
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WuhanChinaRecruiting
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271928
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Xi'anChinaRecruiting
Henan Cancer Hospital /ID# 271927
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ZhengzhouChinaRecruiting
Rambam Health Care Campus- Haifa /ID# 270078
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HaifaIsraelRecruiting
Shaare Zedek Medical Center /ID# 270095
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JerusalemIsraelCompleted
Meir Medical Center /ID# 270071
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Kefar SavaIsraelRecruiting
Rabin Medical Center. /ID# 270087
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Petah TikvaIsraelRecruiting
The Chaim Sheba Medical Center /ID# 270068
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Ramat GanIsraelRecruiting
Fujieda Municipal General Hospital /ID# 277025
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FujiedaJapanRecruiting
National Cancer Center Hospital East /ID# 277056
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Kashiwa-shiJapanRecruiting
Kobe Minimally Invasive Cancer Center /ID# 277469
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KobeJapanRecruiting
Kurashiki Central Hospital /ID# 276995
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Kurashiki-shiJapanRecruiting
University of Miyazaki Hospital /ID# 277020
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MiyazakiJapanRecruiting
Nagoya University Hospital /ID# 277010
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NagoyaJapanRecruiting
Kitasato University Hospital /ID# 277012
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Sagamihara-shiJapanRecruiting
Hokkaido University Hospital /ID# 277014
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SapporoJapanRecruiting
Sendai Kousei Hospital /ID# 277023
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SendaiJapanRecruiting
Wakayama Medical University Hospital /ID# 276997
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WakayamaJapanRecruiting
Military Medical Academy /ID# 279873
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BelgradeSerbiaRecruiting
Institute for Oncology and Radiology of Serbia /ID# 270561
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BelgradeSerbiaRecruiting
University Clinical Center Serbia /ID# 270808
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BelgradeSerbiaRecruiting
Clinical Hospital Center - Bezanijska Kosa /ID# 270558
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BelgradeSerbiaRecruiting
Institute For Pulmonary Diseases Of Vojvodina /ID# 270559
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KamenitzSerbiaRecruiting
University Clinical Center Kragujevac /ID# 275773
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KragujevacSerbiaRecruiting
University Clinical Center Nis /ID# 270557
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NišSerbiaRecruiting
National Cancer Centre Singapore /ID# 271499
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SingaporeSingaporeRecruiting
National University Hospital /ID# 271700
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SingaporeSingaporeRecruiting
University Cancer and Blood Center /ID# 270969
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AthensUnited StatesRecruiting
Ironwood Cancer and Research Center /ID# 276370
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ChandlerUnited StatesRecruiting
Medical University of South Carolina /ID# 273272
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CharlestonUnited StatesRecruiting
University of Illinois Hospital and Health Sciences System /ID# 275345
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ChicagoUnited StatesRecruiting
Texas Oncology - Dallas - Worth Street /ID# 278947
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DallasUnited StatesRecruiting
Astera Cancer Care /ID# 272359
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East BrunswickUnited StatesRecruiting
Virginia Cancer Specialists - Fairfax /ID# 272004
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FairfaxUnited StatesRecruiting
Saint Francis Cancer Center - Greenville /ID# 276368
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GreenvilleUnited StatesRecruiting
Kaiser Permanente Moanalua Medical Center /ID# 272916
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HonoluluUnited StatesRecruiting
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899
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JacksonvilleUnited StatesRecruiting
Nebraska Hematology-Oncology /ID# 272970
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LincolnUnited StatesRecruiting
University of Arkansas for Medical Sciences /ID# 272923
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Little RockUnited StatesRecruiting
Valkyrie Clinical Trials /ID# 271322
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Los AngelesUnited StatesRecruiting
Start Los Angeles /ID# 284999
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Los AngelesUnited StatesRecruiting
Northwest Georgia Oncology Centers /ID# 275374
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MariettaUnited StatesRecruiting
SCRI Oncology Partners /ID# 270162
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NashvilleUnited StatesRecruiting
Yale New Haven Hospital /ID# 271584
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New HavenUnited StatesCompleted
Illinois Cancer Specialists /ID# 274678
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NilesUnited StatesRecruiting
Ocala Oncology Center /ID# 273697
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OcalaUnited StatesRecruiting
Community Cancer Trials Of Utah /ID# 276598
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OgdenUnited StatesRecruiting
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527
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OmahaUnited StatesRecruiting
FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 284816
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OxnardUnited StatesRecruiting
Memorial Hospital West /ID# 270313
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Pembroke PinesUnited StatesRecruiting
OSF St. Francis Medical Center /ID# 281591
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PeoriaUnited StatesRecruiting
Mercy Health - Perrysburg Cancer Center /ID# 270536
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PerrysburgUnited StatesRecruiting
FirstHealth of the Carolinas- Speciality Center /ID# 272924
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PinehurstUnited StatesRecruiting
Renown Regional Medical Center /ID# 273535
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RenoUnited StatesRecruiting
Memorial University Medical Center /ID# 272467
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SavannahUnited StatesCompleted
Guthrie Robert Packer Hospital /ID# 270316
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SayreUnited StatesRecruiting
Medical Oncology Associates - Spokane /ID# 277172
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SpokaneUnited StatesRecruiting
Springfield Clinic - First /ID# 272576
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SpringfieldUnited StatesRecruiting
Comprehensive Hematology Oncology /ID# 270422
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St. PetersburgUnited StatesRecruiting
Florida Cancer Specialists - North /ID# 271995
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St. PetersburgUnited StatesRecruiting
Northwest Medical Specialties Tacoma /ID# 270534
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TacomaUnited StatesRecruiting
Regional Cancer Care Associates /ID# 270783
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TeaneckUnited StatesRecruiting
Montefiore Medical Center - Einstein Campus /ID# 277169
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The BronxUnited StatesRecruiting
Texas Oncology - Northeast Texas /ID# 272000
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TylerUnited StatesRecruiting
Clinical Research Alliance (SMO/Network/Consortium) /ID# 270455
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WestburyUnited StatesRecruiting
Florida Cancer Specialists - East /ID# 271993
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West Palm BeachUnited StatesRecruiting
Cancer Care Associates Of York /ID# 270971
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YorkUnited StatesRecruiting
Genesis Healthcare System /ID# 273361
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ZanesvilleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.