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A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
NCT04928846 · 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 determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. 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 Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 330 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. At the conclusion of the study, participants who continue to demonstrate clinical benefit may be eligible to receive study treatment via an extension of the study, a rollover study, or through another mechanism. 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 Docetaxel
- BIOLOGICAL Telisotuzumab Vedotin
Study Locations (20)
California
- City of Hope /ID# 243157 — Duarte
- City Of Hope - Seacliff /ID# 263143 — Huntington Beach
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144 — Irvine
- City Of Hope - Antelope Valley /ID# 263138 — Lancaster
- The Oncology Institute Of Hope & Innovation -East Los A /ID# 239774 — Los Angeles
- University of California, Los Angeles /ID# 253954 — Los Angeles
- Eisenhower Medical Center /ID# 233189 — Rancho Mirage
Arizona
- Ironwood Cancer & Res Ctr /ID# 262446 — Chandler
- Mayo Clinic Arizona /ID# 255858 — Phoenix
- Onvida Health Yuma Medical Center /ID# 253625 — Yuma
Florida
- Mayo Clinic Hospital Jacksonville /ID# 254688 — Jacksonville
- Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228 — Ocala
- BRCR Medical Center Inc /ID# 262344 — Tamarac
Illinois
- Edward-Elmhurst Cancer Center /ID# 238552 — Elmhurst
- Springfield Clinic - First /ID# 262290 — Springfield
Indiana
- Goshen Center for Cancer Care /ID# 257734 — Goshen
- Investigative Clinical Research of Indiana - Indianapolis /ID# 260468 — Indianapolis
Alabama
- University of Alabama at Birmingham - Main /ID# 247074 — Birmingham
Georgia
- Memorial University Medical Center /ID# 264081 — Savannah
Hawaii
- Kaiser Permanente Moanalua Medical Center /ID# 238363 — Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 698 participants |
| Start Date | 2022-03-25 |
| Est. Completion | 2028-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04928846
The ClinicalTrials.gov registry entry for NCT04928846 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 698 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 2 interventions — of which Docetaxel 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: NCT04928846 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Arizona, Florida. 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 NCT04928846 about?
NCT04928846 is a clinical study titled "A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel 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 determine if telisotuzumab vedotin works better than d...
What is the current status of trial NCT04928846?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 698 participants. The study started on 2022-03-25. Estimated completion is 2028-03.
What conditions does trial NCT04928846 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 NCT04928846?
The interventions under investigation include: Docetaxel (DRUG), Telisotuzumab Vedotin (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04928846?
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 NCT04928846 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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