Recruiting

Phase 2

Telisotuzumab VedotinA 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)

Sponsor:

AbbVie

Code:

NCT06568939

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telisotuzumab Vedotin

Study Details

Brief 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 80 to 90 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

Non-Small Cell Lung Cancer

Study ID

NCT06568939

Start date

Jan 20, 2025

Status verified date

Aug, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Projected life expectancy of at least 12 weeks.
Must have c-Met overexpressing non-small cell lung cancer (NSCLC) (defined as >= 25% tumor cells with 3+ staining (high \[>= 50% 3+\]; intermediate \[>= 25% - < 50%\]) as assessed by a Sponsor designated immunohistochemistry (IHC) laboratory
Must have histologically or cytologically documented NSCLC that is locally advanced or metastatic.
Must have a known epidermal growth factor receptor (EGFR) activating mutation status.
Actionable alterations in genes other than EGFR are permitted.
Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Must have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting, as stated in the protocol.
Must have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC, as stated in the protocol.

Exclusion Criteria:

Adenosquamous or neuroendocrine histology, or sarcomatoid features.
EGFR activating mutations (e.g., EGFR Exon 19 deletions, T790M, Exon 21 L858R, or Exon 20 insertion mutations).
Received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E.
Received prior docetaxel therapy.
Metastases to the central nervous system (CNS). Participants with CNS metastases are eligible only after adequate treatment (such as surgery or, radiotherapy, or drug therapy) is provided, as stated on the protocol.
History of other malignancies except those stated in the protocol.
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan, as noted in the protocol.
Unresolved clinically significant adverse event (AE) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.
Major surgery within 21 days prior to randomization.
Clinically significant condition(s) including but not limited to those listed in the protocol.
Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis.
Grade >= 2 edema or lymphedema.
Grade >= 2 ascites or pleural effusion.
Grade >= 2 neuropathy.
Active uncontrolled bacterial or viral infection.
Active corneal disorder.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Telisotuzumab Vedotin Dose A

Participants will receive telisotuzumab vedotin dose A, as part of the 3 year study duration.

experimental: Telisotuzumab Vedotin Dose B

Participants will receive telisotuzumab vedotin dose B, as part of the 3 year study duration.

experimental: Telisotuzumab Vedotin Dose C

Participants will receive telisotuzumab vedotin dose C, as part of the 3 year study duration.

Interventions

Telisotuzumab Vedotin

Intravenous (IV) Infusion

Primary outcome measure

Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2) [ Time Frame: Up to Approximately 3 Years ]
Percentage of Participants with Treatment-Emergent Interstitial Lung Disease (ILD) [ Time Frame: Up to Approximately 3 Years ]
Percentage of Participants with Treatment-Emergent Peripheral Neuropathy [ Time Frame: Up to Approximately 3 Years ]
Percentage of Participants with Treatment-Emergent Ocular Surface Disorders [ Time Frame: Up to Approximately 3 Years ]
Percentage of Participants with Treatment-Emergent AEs Leading to Study Drug Discontinuation [ Time Frame: Up to Approximately 3 Years ]
Percentage of Participants with Grade 5 Treatment-Emergent AEs [ Time Frame: Up to Approximately 3 Years ]
Objective Response (OR) by Blinded Independent Central Review (BICR) [ Time Frame: Up to Approximately 3 Years ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

Ironwood Cancer and Research Center /ID# 276370

Recruiting

Chandler, Arizona, United States, 85224

University of Arkansas for Medical Sciences /ID# 272923

Recruiting

Little Rock, Arkansas, United States, 72205

Valkyrie Clinical Trials /ID# 271322

Recruiting

Los Angeles, California, United States, 90067

FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 284816

Recruiting

Oxnard, California, United States, 93030

Yale New Haven Hospital /ID# 271584

Recruiting

New Haven, Connecticut, United States, 06510

Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899

Recruiting

Jacksonville, Florida, United States, 32256

Ocala Oncology Center /ID# 273697

Recruiting

Ocala, Florida, United States, 34474

Memorial Hospital West /ID# 270313

Recruiting

Pembroke Pines, Florida, United States, 33028

Comprehensive Hematology Oncology /ID# 270422

Recruiting

St. Petersburg, Florida, United States, 33701-4732

Florida Cancer Specialists - North /ID# 271995

Recruiting

St. Petersburg, Florida, United States, 33705

Florida Cancer Specialists - East /ID# 271993

Recruiting

West Palm Beach, Florida, United States, 33401

University Cancer & Blood Center /ID# 270969

Recruiting

Athens, Georgia, United States, 30607

Northwest Georgia Oncology Centers /ID# 275374

Recruiting

Marietta, Georgia, United States, 30060

Kaiser Permanente Moanalua Medical Center /ID# 272916

Recruiting

Honolulu, Hawaii, United States, 96819

University of Illinois Hospital and Health Sciences System /ID# 275345

Recruiting

Chicago, Illinois, United States, 60607

Illinois Cancer Specialists /ID# 274678

Recruiting

Niles, Illinois, United States, 60714

Springfield Clinic - First /ID# 272576

Recruiting

Springfield, Illinois, United States, 62702

Nebraska Hematology-Oncology /ID# 272970

Recruiting

Lincoln, Nebraska, United States, 68506

Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527

Recruiting

Omaha, Nebraska, United States, 68130

Renown Regional Medical Center /ID# 273535

Recruiting

Reno, Nevada, United States, 89502

Astera Cancer Care /ID# 272359

Recruiting

East Brunswick, New Jersey, United States, 08816-4096

Regional Cancer Care Associates /ID# 270783

Recruiting

Teaneck, New Jersey, United States, 07666

Montefiore Medical Center - Einstein Campus /ID# 277169

Recruiting

The Bronx, New York, United States, 10461

Clinical Research Alliance - Westbury /ID# 270455

Recruiting

Westbury, New York, United States, 11590

FirstHealth of the Carolinas- Speciality Center /ID# 272924

Recruiting

Pinehurst, North Carolina, United States, 28374

Mercy Health - Perrysburg Cancer Center /ID# 270536

Recruiting

Perrysburg, Ohio, United States, 43551

Genesis Healthcare System /ID# 273361

Recruiting

Zanesville, Ohio, United States, 43701

Guthrie Robert Packer Hospital /ID# 270316

Recruiting

Sayre, Pennsylvania, United States, 18840

Cancer Care Associates Of York /ID# 270971

Recruiting

York, Pennsylvania, United States, 17403

Medical University of South Carolina /ID# 273272

Recruiting

Charleston, South Carolina, United States, 29425

Saint Francis Cancer Center - Greenville /ID# 276368

Recruiting

Greenville, South Carolina, United States, 29607

SCRI Oncology Partners /ID# 270162

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology - Dallas - Worth Street /ID# 278947

Recruiting

Dallas, Texas, United States, 75246

Texas Oncology - Northeast Texas /ID# 272000

Recruiting

Tyler, Texas, United States, 75702

Community Cancer Trials Of Utah /ID# 276598

Recruiting

Ogden, Utah, United States, 84405

Virginia Cancer Specialists - Fairfax /ID# 272004

Recruiting

Fairfax, Virginia, United States, 22031

Medical Oncology Associates - Spokane /ID# 277172

Recruiting

Spokane, Washington, United States, 99208

Northwest Medical Specialties Tacoma /ID# 270534

Recruiting

Tacoma, Washington, United States, 98405

More Information

Sponsor

AbbVie

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

Non-Small Cell Lung Cancer
NSCLC
Telisotuzumab Vedotin
ABBV-399
TeliMET NSCLC-04

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-02.