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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 · View on ClinicalTrials.gov ↗
Study Summary
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 70 to 80 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.
Conditions Studied
Interventions
- DRUG Telisotuzumab Vedotin
Study Locations (20)
Florida
- Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899 — Jacksonville
- Ocala Oncology Center /ID# 273697 — Ocala
- Comprehensive Hematology Oncology /ID# 270422 — St. Petersburg
- Florida Cancer Specialists - North /ID# 271995 — St. Petersburg
- Florida Cancer Specialists - East /ID# 271993 — West Palm Beach
Georgia
- University Cancer & Blood Center /ID# 270969 — Athens
- Northwest Georgia Oncology Centers /ID# 275374 — Marietta
- Memorial University Medical Center /ID# 272467 — Savannah
Illinois
- University of Illinois Hospital and Health Sciences System /ID# 275345 — Chicago
- Illinois Cancer Specialists /ID# 274678 — Niles
- Springfield Clinic - First /ID# 272576 — Springfield
Nebraska
- NHO - Nebraska Hematology-Oncology /ID# 272970 — Lincoln
- Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527 — Omaha
Arizona
- Ironwood Cancer & Research Center /ID# 276370 — Chandler
Arkansas
- University of Arkansas for Medical Sciences /ID# 272923 — Little Rock
California
- Valkyrie Clinical Trials /ID# 271322 — Los Angeles
Connecticut
- Yale New Haven Hospital /ID# 271584 — New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-01-20 |
| Est. Completion | 2028-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06568939
The ClinicalTrials.gov registry entry for NCT06568939 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention — of which Telisotuzumab Vedotin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06568939 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Georgia, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06568939 about?
NCT06568939 is a clinical study titled "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)". 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 part...
What is the current status of trial NCT06568939?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2025-01-20. Estimated completion is 2028-02.
What conditions does trial NCT06568939 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06568939?
The interventions under investigation include: Telisotuzumab Vedotin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06568939?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06568939 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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