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)

February 19, 2026 updated by: AbbVie

A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 101149
        • Recruiting
        • Beijing Chest Tumor Hospital /ID# 271935
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital /ID# 271927
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital - Tongji Medical College /ID# 271668
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University /ID# 271666
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271928
    • Shandong
      • Linyi, Shandong, China, 276034
        • Recruiting
        • Linyi Cancer Hospital /ID# 272068
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830011
        • Recruiting
        • Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933
  • Israel
      • Haifa, Israel, 3525408
        • Recruiting
        • Rambam Health Care Campus- Haifa /ID# 270078
      • Jerusalem, Israel, 9103102
        • Completed
        • Shaare Zedek Medical Center /ID# 270095
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center. /ID# 270087
    • Central District
      • Kfar Saba, Central District, Israel, 4428164
        • Recruiting
        • Meir Medical Center /ID# 270071
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Recruiting
        • Nagoya University Hospital /ID# 277010
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital /ID# 277014
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0046
        • Recruiting
        • Kobe Minimally Invasive Cancer Center /ID# 277469
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan, 252-0375
        • Recruiting
        • Kitasato University Hospital /ID# 277012
    • Miyagi
      • Sendai, Miyagi, Japan, 981-0914
        • Recruiting
        • Sendai Kousei Hospital /ID# 277023
    • Miyazaki
      • Miyazaki, Miyazaki, Japan, 889-1692
        • Recruiting
        • University of Miyazaki Hospital /ID# 277020
    • Okayama-ken
      • Kurashiki-shi, Okayama-ken, Japan, 710-8602
        • Recruiting
        • Kurashiki Central Hospital /ID# 276995
    • Shizuoka
      • Fujieda, Shizuoka, Japan, 426-0077
        • Recruiting
        • Fujieda Municipal General Hospital /ID# 277025
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University Hospital /ID# 276997
  • Serbia
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Recruiting
        • Institute for Oncology and Radiology of Serbia /ID# 270561
      • Belgrade, Beograd, Serbia, 11080
        • Recruiting
        • Clinical Hospital Center - Bežanijska Kosa /ID# 270558
      • Belgrade, Beograd, Serbia, 11000
        • Recruiting
        • University Clinical Center Serbia /ID# 270808
    • Nisavski Okrug
      • Niš, Nisavski Okrug, Serbia, 18300
        • Recruiting
        • University Clinical Center Nis /ID# 270557
    • Sremski Okrug
      • Kamenitz, Sremski Okrug, Serbia, 21208
        • Recruiting
        • Institute For Pulmonary Diseases Of Vojvodina /ID# 270559
    • Sumadijski Okrug
      • Kragujevac, Sumadijski Okrug, Serbia, 34000
        • Recruiting
        • University Clinical Center Kragujevac /ID# 275773
  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital /ID# 271700
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 169611
        • Recruiting
        • National Cancer Centre Singapore /ID# 271499
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Ironwood Cancer & Research Center /ID# 276370
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences /ID# 272923
    • California
      • Los Angeles, California, United States, 90067
        • Recruiting
        • Valkyrie Clinical Trials /ID# 271322
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Hospital /ID# 271584
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899
      • Ocala, Florida, United States, 34474
        • Recruiting
        • Ocala Oncology Center /ID# 273697
      • St. Petersburg, Florida, United States, 33701-4732
        • Recruiting
        • Comprehensive Hematology Oncology /ID# 270422
      • St. Petersburg, Florida, United States, 33705
        • Recruiting
        • Florida Cancer Specialists - North /ID# 271995
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Florida Cancer Specialists - East /ID# 271993
    • Georgia
      • Athens, Georgia, United States, 30607
        • Recruiting
        • University Cancer & Blood Center /ID# 270969
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Northwest Georgia Oncology Centers /ID# 275374
      • Savannah, Georgia, United States, 31404
        • Recruiting
        • Memorial University Medical Center /ID# 272467
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Recruiting
        • Kaiser Permanente Moanalua Medical Center /ID# 272916
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • University of Illinois Hospital and Health Sciences System /ID# 275345
      • Niles, Illinois, United States, 60714
        • Recruiting
        • Illinois Cancer Specialists /ID# 274678
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic - First /ID# 272576
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • NHO - Nebraska Hematology-Oncology /ID# 272970
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center /ID# 273535
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816-4096
        • Recruiting
        • Astera Cancer Care /ID# 272359
    • New York
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center /ID# 277169
      • Westbury, New York, United States, 11590
        • Recruiting
        • Clinical Research Alliance - Westbury /ID# 270455
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • Recruiting
        • FirstHealth of the Carolinas- Speciality Center /ID# 272924
    • Ohio
      • Perrysburg, Ohio, United States, 43551
        • Recruiting
        • Mercy Health - Perrysburg Cancer Center /ID# 270536
      • Zanesville, Ohio, United States, 43701
        • Recruiting
        • Genesis Healthcare System /ID# 273361
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Recruiting
        • Guthrie Robert Packer Hospital /ID# 270316
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Cancer Care Associates Of York /ID# 270971
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina /ID# 273272
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Saint Francis Cancer Center - Greenville /ID# 276368
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners /ID# 270162
    • Texas
      • Tyler, Texas, United States, 75702
        • Recruiting
        • Texas Oncology - Northeast Texas /ID# 272000
    • Utah
      • Ogden, Utah, United States, 84405
        • Recruiting
        • Community Cancer Trials Of Utah /ID# 276598
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists - Fairfax /ID# 272004
    • Washington
      • Spokane, Washington, United States, 99208
        • Recruiting
        • Medical Oncology Associates - Spokane /ID# 277172
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Northwest Medical Specialties Tacoma /ID# 270534

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Projected life expectancy of at least 12 weeks.
  • Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie 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.
  • Actionable EGFR activating 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telisotuzumab Vedotin Dose A
Participants will receive telisotuzumab vedotin dose A, as part of the 3 year study duration.
Drug: Telisotuzumab Vedotin
Intravenous (IV) Infusion
Other Names:
  • ABBV-399
Experimental: Telisotuzumab Vedotin Dose B
Participants will receive telisotuzumab vedotin dose B, as part of the 3 year study duration.
Drug: Telisotuzumab Vedotin
Intravenous (IV) Infusion
Other Names:
  • ABBV-399
Experimental: Telisotuzumab Vedotin Dose C
Participants will receive telisotuzumab vedotin dose C, as part of the 3 year study duration.
Drug: Telisotuzumab Vedotin
Intravenous (IV) Infusion
Other Names:
  • ABBV-399

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2)
Time Frame: Up to Approximately 3 Years
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.
Up to Approximately 3 Years
Percentage of Participants with Treatment-Emergent Interstitial Lung Disease (ILD)
Time Frame: Up to Approximately 3 Years
ILD is defined by ILD standardized MedDRA query (SMQ) (broad) per investigator and determined per adjudication (any-grade and Grade >= 2).
Up to Approximately 3 Years
Percentage of Participants with Treatment-Emergent Peripheral Neuropathy
Time Frame: Up to Approximately 3 Years
Peripheral neuropathy is defined by peripheral neuropathy SMQ (narrow) (any-grade and Grade >= 2)
Up to Approximately 3 Years
Percentage of Participants with Treatment-Emergent Ocular Surface Disorders
Time Frame: Up to Approximately 3 Years
Treatment-emergent ocular surface disorders defined by corneal epitheliopathy company MedDRA query (CMQ) (any-grade and Grade >= 2).
Up to Approximately 3 Years
Percentage of Participants with Treatment-Emergent AEs Leading to Study Drug Discontinuation
Time Frame: Up to Approximately 3 Years
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.
Up to Approximately 3 Years
Percentage of Participants with Grade 5 Treatment-Emergent AEs
Time Frame: Up to Approximately 3 Years
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.
Up to Approximately 3 Years
Objective Response (OR) by Blinded Independent Central Review (BICR)
Time Frame: Up to Approximately 3 Years
OR will be defined as achieving confirmed complete response (CR) or confirmed partial response (PR) based on response evaluation criteria in solid tumors (RECIST), version 1.1.
Up to Approximately 3 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentrations of Telisotuzumab Vedotin Conjugate in Serum
Time Frame: Up to 26 Weeks
Concentrations of telisotuzumab vedotin conjugate in serum.
Up to 26 Weeks
Concentrations of Monomethylauristatin E (MMAE) Payload in Plasma
Time Frame: Up to 26 Weeks
Concentrations of MMAE payload in plasma.
Up to 26 Weeks
Percentage of Participants with Antidrug Antibodies (ADAs) of Telisotuzumab Vedotin
Time Frame: Up to 26 Weeks
Percentage of participants with ADAs of telisotuzumab vedotin.
Up to 26 Weeks
Percentage of Participants with Neutralizing Antidrug Antibodies (nADAs) of Telisotuzumab Vedotin
Time Frame: Up to 26 Weeks
Percentage of participants with nADAs of telisotuzumab vedotin.
Up to 26 Weeks
Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time Frame: Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years
The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in patients participating in cancer clinical trials. PRO-CTCAE includes 124 items representing 78 symptomatic toxicities drawn from the Common Terminology Criteria for Adverse Events (CTCAE). PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. All questions employ a 7-day recall period and are scored from 0 to 4 (or 0/1 for absent/present).
Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years
Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G)
Time Frame: Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years
The GP5 item ("I am bothered by side effects of treatment") of FACT-G is used to assess overall treatment tolerability in patients by assessing the overall side effect impact on participants.
Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years
Duration of Response (DoR) by BICR
Time Frame: Up to Approximately 3 Years
DoR is defined for confirmed responders as the time from the participants' initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause.
Up to Approximately 3 Years
Progression-Free Survival (PFS) by BICR
Time Frame: Up to Approximately 3 Years
PFS will be defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 or death from any cause.
Up to Approximately 3 Years
Overall Survival (OS)
Time Frame: Up to Approximately 3 Years
OS will be defined as the time from randomization to death from any cause.
Up to Approximately 3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

August 22, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M25-274

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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