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NCT04928846 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 698
- Enrollment target
- 20
- Study locations
NCT04928846: Recruiting Phase 3 study of Non-Small Cell Lung Cancer, sponsored by AbbVie.
NCT04928846 is a Phase 3 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by AbbVie. The registered enrollment target is 698 participants, roughly in line with the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target. The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04928846, a Phase 3 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 698 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per BICR or death from any cause.
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 |
What NCT04928846 shows while recruiting
NCT04928846 is an interventional study that assigns participants to a tested intervention. The registered 698 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target.
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.
NCT04928846 names 20 study sites across 8 states, led by California, Arizona, Florida.
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.
What interventions are being tested in trial NCT04928846?
The interventions under investigation include: Docetaxel (DRUG), Telisotuzumab Vedotin (BIOLOGICAL).
Who is sponsoring clinical trial NCT04928846?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04928846's enrollment target sits among peer trials
698 44th of 454 higher than 411 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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