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A Study of Telisotuzumab Vedotin for Non-Small Cell Lung Cancer

This study is testing an investigational drug called telisotuzumab vedotin for adults with non-small cell lung cancer (NSCLC). NSCLC is a type of lung cancer where cells grow uncontrollably. The main goal is to see how safe telisotuzumab vedotin is and how it moves through the body. Researchers will also look at how the cancer responds to the treatment. To join, you must have NSCLC that has a specific biomarker (a measurable indicator of a disease), called c-Met overexpression, and a projected life expectancy of at least 12 weeks. Participants will receive telisotuzumab vedotin through an IV (intravenous) infusion.

Study design
This study plans to enroll 150 participants. You will be randomly assigned to one of three groups, each receiving a different dose of telisotuzumab vedotin.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06568939

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)

Recruiting
PHASE2Ages 18+InterventionalTreatment
AbbVie
~150 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:Telisotuzumab Vedotin

At a glance

Recruiting sites
79 of 81 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2)
Measured over Up to Approximately 3 Years
+6 more outcomes measured

Conditions

Non-Small Cell Lung Cancer

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NCT06568939

Where you'd take part

This study runs at 81 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931

    Nanning, Guangxi, Chinano site contact published

    Recruiting

  • Astera Cancer Care /ID# 272359

    East Brunswick, New Jerseyno site contact published

    Recruiting

  • Beijing Chest Tumor Hospital /ID# 271935

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • Cancer Care Associates Of York /ID# 270971

    York, Pennsylvaniano site contact published

    Recruiting

  • Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933

    Ürümqi, Xinjiang, Chinano site contact published

    Recruiting

  • Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899

    Jacksonville, Floridano site contact published

    Recruiting

  • Cepen - Centro De Pesquisa E Ensino Em Oncologia De Santa Catarina /ID# 273204

    Florianópolis, Santa Catarina, Brazilno site contact published

    Recruiting

  • Clinical Hospital Center - Bezanijska Kosa /ID# 270558

    Belgrade, Beograd, Serbiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2)Up to Approximately 3 Years

    An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.

  • Percentage of Participants with Treatment-Emergent Interstitial Lung Disease (ILD)Up to Approximately 3 Years

    ILD is defined by ILD standardized MedDRA query (SMQ) (broad) per investigator and determined per adjudication (any-grade and Grade \>= 2).

  • Percentage of Participants with Treatment-Emergent Peripheral NeuropathyUp to Approximately 3 Years

    Peripheral neuropathy is defined by peripheral neuropathy SMQ (narrow) (any-grade and Grade \>= 2)

  • Percentage of Participants with Treatment-Emergent Ocular Surface DisordersUp to Approximately 3 Years

    Treatment-emergent ocular surface disorders defined by corneal epitheliopathy company MedDRA query (CMQ) (any-grade and Grade \>= 2).

  • Percentage of Participants with Treatment-Emergent AEs Leading to Study Drug DiscontinuationUp to Approximately 3 Years

    An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.

  • Percentage of Participants with Grade 5 Treatment-Emergent AEsUp to Approximately 3 Years

    An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.

  • Objective Response (OR) by Blinded Independent Central Review (BICR)Up to Approximately 3 Years

    OR will be defined as achieving confirmed complete response (CR) or confirmed partial response (PR) based on response evaluation criteria in solid tumors (RECIST), version 1.1.