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)

ClinicalTrials.gov ID: NCT04928846

Public ClinicalTrials.gov record NCT04928846. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 8, 2026, 7:13 PM EDT

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Official title

A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 telisotuzumab vedotin or docetaxel at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 768 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.

Study identification

NCT ID: NCT04928846
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: AbbVie; Industry
Enrollment: 768 participants

Conditions and interventions

Conditions

Non Small Cell Lung Cancer

Interventions

Telisotuzumab Vedotin Biological
Docetaxel Drug

Biological · Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 24, 2022
Primary completion: Nov 30, 2028
Completion: Jan 31, 2029
Last update posted: Jul 27, 2026

2022 – 2029

United States locations

U.S. sites: 50
U.S. states: 29
U.S. cities: 49

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham - Main /ID# 247074	Birmingham	Alabama	35233	Active, not recruiting
Ironwood Cancer & Res Ctr /ID# 262446	Chandler	Arizona	85224-5665	Active, not recruiting
Mayo Clinic Arizona /ID# 255858	Phoenix	Arizona	85054-4504	Active, not recruiting
Onvida Health Yuma Medical Center /ID# 253625	Yuma	Arizona	85364	Completed
City of Hope /ID# 243157	Duarte	California	91010	Recruiting
City Of Hope - Seacliff /ID# 263143	Huntington Beach	California	92648	Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144	Irvine	California	92618	Recruiting
City Of Hope - Antelope Valley /ID# 263138	Lancaster	California	93534	Recruiting
The Oncology Institute Of Hope & Innovation -East Los A /ID# 239774	Los Angeles	California	90033	Completed
Eisenhower Medical Center /ID# 233189	Rancho Mirage	California	92270-3221	Completed
Premiere Oncology Foundation /ID# 253954	Santa Monica	California	90404	Completed
Mayo Clinic Hospital Jacksonville /ID# 254688	Jacksonville	Florida	32224	Completed
Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228	Ocala	Florida	34474-4445	Completed
BRCR Medical Center Inc /ID# 262344	Tamarac	Florida	33321-2919	Completed
Memorial University Medical Center /ID# 264081	Savannah	Georgia	31404	Completed
Kaiser Permanente Moanalua Medical Center /ID# 238363	Honolulu	Hawaii	96819-1469	Recruiting
Edward-Elmhurst Cancer Center /ID# 238552	Elmhurst	Illinois	60126	Active, not recruiting
Springfield Clinic - First /ID# 262290	Springfield	Illinois	62702	Active, not recruiting
Goshen Center for Cancer Care /ID# 257734	Goshen	Indiana	46526	Completed
Investigative Clinical Research of Indiana - Indianapolis /ID# 260468	Indianapolis	Indiana	46260	Completed
Baptist Health Lexington /ID# 252769	Lexington	Kentucky	40503	Completed
Dana-Farber Cancer Institute /ID# 247132	Boston	Massachusetts	02215	Completed
Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190	Ypsilanti	Michigan	48197-1051	Completed
Mayo Clinic - Rochester /ID# 252052	Rochester	Minnesota	55905-0001	Active, not recruiting
Hattiesburg Clinic /ID# 248033	Hattiesburg	Mississippi	39401	Recruiting
St. Luke's Hospital - Chesterfield /ID# 251688	Chesterfield	Missouri	63017	Completed
St. Lukes Hosp. of Kansas City /ID# 259940	Kansas City	Missouri	64111	Recruiting
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567	Kansas City	Missouri	64114-4859	Completed
Hulston Cancer Center /ID# 232226	Springfield	Missouri	65807-5287	Recruiting
Saint Louis University Cancer Center /ID# 260722	St Louis	Missouri	63110-2539	Completed
Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147	Billings	Montana	59102	Active, not recruiting
Nebraska Hematology Oncology /ID# 257710	Lincoln	Nebraska	68506	Completed
Renown Medical Group - Oncology/Hematology /ID# 247942	Reno	Nevada	89502-1464	Completed
Astera Cancer Care /ID# 257753	East Brunswick	New Jersey	08816-4096	Completed
San Juan Oncology Associates /ID# 244387	Farmington	New Mexico	87401	Completed
Maimonides Medical Center /ID# 240783	Brooklyn	New York	11219	Active, not recruiting
Northwell Health - Monter Cancer Center /ID# 247081	Lake Success	New York	11042	Completed
AdventHealth Hendersonville /ID# 265349	Hendersonville	North Carolina	28792	Completed
FirstHealth of the Carolinas- Speciality Center /ID# 241279	Pinehurst	North Carolina	28374	Completed
Genesis Cancer Care Center /ID# 239190	Zanesville	Ohio	43701-1406	Active, not recruiting
Cancer Care Associates Of York /ID# 266143	York	Pennsylvania	17403	Completed
Medical University of South Carolina /ID# 251383	Charleston	South Carolina	29425	Completed
St Francis Cancer Center /ID# 243596	Greenville	South Carolina	29607-5253	Completed
Avera Cancer Institute - Aberdeen /ID# 257759	Aberdeen	South Dakota	57401	Completed
Avera Cancer Institute /ID# 239635	Sioux Falls	South Dakota	57105	Completed
Duplicate_Memphis VA Medical Center /ID# 263250	Memphis	Tennessee	38104	Completed
Dell Seton Medical Center /ID# 247016	Austin	Texas	78701	Active, not recruiting
Community Cancer Trials of Utah - South Ogden /ID# 262829	Ogden	Utah	84405-7194	Completed
Valley Medical Center /ID# 253950	Renton	Washington	98055-5738	Recruiting
Medical Oncology Associates /ID# 247003	Spokane	Washington	99208	Completed

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 267 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04928846, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 27, 2026 · Synced Sep 8, 2026

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