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NCT06568939 · ClinicalTrials.gov registry record · Phase 2

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)

A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by AbbVie.

Recruiting
Registry status
Phase 2
Development phase
150
Enrollment target
20
Study locations

NCT06568939: Recruiting Phase 2 study of Non-Small Cell Lung Cancer, sponsored by AbbVie.

NCT06568939 is a Phase 2 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by AbbVie. The registered enrollment target is 150 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06568939, a Phase 2 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 2
Development phase
150 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 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.

Primary Outcome

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.

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

FieldValue
Enrollment Target 150 participants
Start Date 2025-01-20
Est. Completion 2028-02
Phase Phase 2
AbbVie

526 total trials

What NCT06568939 shows while recruiting

NCT06568939 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (77% lower).

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.

NCT06568939 names 20 study sites across 11 states, led by Florida, Georgia, Illinois.

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.

What interventions are being tested in trial NCT06568939?

The interventions under investigation include: Telisotuzumab Vedotin (DRUG).

Who is sponsoring clinical trial NCT06568939?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Non-Small Cell Lung Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06568939's enrollment target sits among peer trials

150 197th of 454 higher than 256 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06568939, the US trial registry maintained by the National Library of Medicine. NCT06568939 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.