NCT06568939 · AbbVie
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)
What this study 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 side effects will be assessed.
View original scientific description
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.
Interventions
DRUG
Telisotuzumab Vedotin
Intravenous (IV) Infusion
Primary outcome measures
Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2)
Time frame: 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)
Time frame: 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 Neuropathy
Time frame: Up 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 Disorders
Time frame: Up 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 Discontinuation
Time frame: 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 Grade 5 Treatment-Emergent AEs
Time frame: 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.
Objective Response (OR) by Blinded Independent Central Review (BICR)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Projected life expectancy of at least 12 weeks.
- Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie 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 histolo
Where
- Chandler, Arizona
- Little Rock, Arkansas
- Los Angeles, California
- New Haven, Connecticut
- Jacksonville, Florida
- Ocala, Florida
- Pembroke Pines, Florida
- St. Petersburg, Florida
- West Palm Beach, Florida
- Athens, Georgia
- Marietta, Georgia
- Savannah, Georgia
And 25 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations