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)

NCT06568939 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: M25-274
• Study Type: interventional
• Target: 150
• Locations: 6 countries
• Sites: 64

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 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.

Conditions

Non-Small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2)

  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)

  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

  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

  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

  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

  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)

  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 Outcomes (9)

• Concentrations of Telisotuzumab Vedotin Conjugate in Serum

  Up to 26 Weeks

• Concentrations of Monomethylauristatin E (MMAE) Payload in Plasma

  Up to 26 Weeks

• Percentage of Participants with Antidrug Antibodies (ADAs) of Telisotuzumab Vedotin

  Up to 26 Weeks

• Percentage of Participants with Neutralizing Antidrug Antibodies (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)

  Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years

Study Arms (3)

Telisotuzumab Vedotin Dose A

EXPERIMENTAL

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

Drug: Telisotuzumab Vedotin

Telisotuzumab Vedotin Dose B

EXPERIMENTAL

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

Drug: Telisotuzumab Vedotin

Telisotuzumab Vedotin Dose C

EXPERIMENTAL

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

Drug: Telisotuzumab Vedotin

Interventions

Telisotuzumab Vedotin DRUG

Intravenous (IV) Infusion

Also known as: ABBV-399

Telisotuzumab Vedotin Dose A; Telisotuzumab Vedotin Dose B; Telisotuzumab Vedotin Dose C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (64)

Ironwood Cancer & Research Center /ID# 276370

Chandler, Arizona, 85224, United States

RECRUITING

University of Arkansas for Medical Sciences /ID# 272923

Little Rock, Arkansas, 72205, United States

RECRUITING

Valkyrie Clinical Trials /ID# 271322

Los Angeles, California, 90067, United States

RECRUITING

Yale New Haven Hospital /ID# 271584

New Haven, Connecticut, 06510, United States

RECRUITING

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

Jacksonville, Florida, 32256, United States

RECRUITING

Ocala Oncology Center /ID# 273697

Ocala, Florida, 34474, United States

RECRUITING

Comprehensive Hematology Oncology /ID# 270422

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

RECRUITING

Florida Cancer Specialists - North /ID# 271995

St. Petersburg, Florida, 33705, United States

RECRUITING

Florida Cancer Specialists - East /ID# 271993

West Palm Beach, Florida, 33401, United States

RECRUITING

University Cancer & Blood Center /ID# 270969

Athens, Georgia, 30607, United States

RECRUITING

Northwest Georgia Oncology Centers /ID# 275374

Marietta, Georgia, 30060, United States

RECRUITING

Memorial University Medical Center /ID# 272467

Savannah, Georgia, 31404, United States

RECRUITING

Kaiser Permanente Moanalua Medical Center /ID# 272916

Honolulu, Hawaii, 96819, United States

RECRUITING

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

Chicago, Illinois, 60607, United States

RECRUITING

Illinois Cancer Specialists /ID# 274678

Niles, Illinois, 60714, United States

RECRUITING

Springfield Clinic - First /ID# 272576

Springfield, Illinois, 62702, United States

RECRUITING

NHO - Nebraska Hematology-Oncology /ID# 272970

Lincoln, Nebraska, 68506, United States

RECRUITING

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

Omaha, Nebraska, 68130, United States

RECRUITING

Renown Regional Medical Center /ID# 273535

Reno, Nevada, 89502, United States

RECRUITING

Astera Cancer Care /ID# 272359

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

RECRUITING

Montefiore Medical Center /ID# 277169

The Bronx, New York, 10461, United States

RECRUITING

Clinical Research Alliance - Westbury /ID# 270455

Westbury, New York, 11590, United States

RECRUITING

FirstHealth of the Carolinas- Speciality Center /ID# 272924

Pinehurst, North Carolina, 28374, United States

RECRUITING

Mercy Health - Perrysburg Cancer Center /ID# 270536

Perrysburg, Ohio, 43551, United States

RECRUITING

Genesis Healthcare System /ID# 273361

Zanesville, Ohio, 43701, United States

RECRUITING

Guthrie Robert Packer Hospital /ID# 270316

Sayre, Pennsylvania, 18840, United States

RECRUITING

Cancer Care Associates Of York /ID# 270971

York, Pennsylvania, 17403, United States

RECRUITING

Medical University of South Carolina /ID# 273272

Charleston, South Carolina, 29425, United States

RECRUITING

Saint Francis Cancer Center - Greenville /ID# 276368

Greenville, South Carolina, 29607, United States

RECRUITING

SCRI Oncology Partners /ID# 270162

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - Northeast Texas /ID# 272000

Tyler, Texas, 75702, United States

RECRUITING

Community Cancer Trials Of Utah /ID# 276598

Ogden, Utah, 84405, United States

RECRUITING

Virginia Cancer Specialists - Fairfax /ID# 272004

Fairfax, Virginia, 22031, United States

RECRUITING

Medical Oncology Associates - Spokane /ID# 277172

Spokane, Washington, 99208, United States

RECRUITING

Northwest Medical Specialties Tacoma /ID# 270534

Tacoma, Washington, 98405, United States

RECRUITING

Beijing Chest Tumor Hospital /ID# 271935

Beijing, Beijing Municipality, 101149, China

RECRUITING

Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931

Nanning, Guangxi, 530021, China

RECRUITING

Henan Cancer Hospital /ID# 271927

Zhengzhou, Henan, 450008, China

RECRUITING

Union Hospital - Tongji Medical College /ID# 271668

Wuhan, Hubei, 430022, China

RECRUITING

The First Affiliated Hospital of Nanchang University /ID# 271666

Nanchang, Jiangxi, 330006, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University /ID# 271928

Xi'an, Shaanxi, 710061, China

RECRUITING

Linyi Cancer Hospital /ID# 272068

Linyi, Shandong, 276034, China

RECRUITING

Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933

Ürümqi, Xinjiang, 830011, China

RECRUITING

Meir Medical Center /ID# 270071

Kfar Saba, Central District, 4428164, Israel

RECRUITING

Rambam Health Care Campus- Haifa /ID# 270078

Haifa, 3525408, Israel

RECRUITING

Shaare Zedek Medical Center /ID# 270095

Jerusalem, 9103102, Israel

COMPLETED

Rabin Medical Center. /ID# 270087

Petah Tikva, 4941492, Israel

RECRUITING

Nagoya University Hospital /ID# 277010

Nagoya, Aichi-ken, 466-8560, Japan

RECRUITING

Hokkaido University Hospital /ID# 277014

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

Kobe Minimally Invasive Cancer Center /ID# 277469

Kobe, Hyōgo, 650-0046, Japan

RECRUITING

Kitasato University Hospital /ID# 277012

Sagamihara-shi, Kanagawa, 252-0375, Japan

RECRUITING

Sendai Kousei Hospital /ID# 277023

Sendai, Miyagi, 981-0914, Japan

RECRUITING

University of Miyazaki Hospital /ID# 277020

Miyazaki, Miyazaki, 889-1692, Japan

RECRUITING

Kurashiki Central Hospital /ID# 276995

Kurashiki-shi, Okayama-ken, 710-8602, Japan

RECRUITING

Fujieda Municipal General Hospital /ID# 277025

Fujieda, Shizuoka, 426-0077, Japan

RECRUITING

Wakayama Medical University Hospital /ID# 276997

Wakayama, Wakayama, 641-8510, Japan

RECRUITING

Institute for Oncology and Radiology of Serbia /ID# 270561

Belgrade, Beograd, 11000, Serbia

RECRUITING

University Clinical Center Serbia /ID# 270808

Belgrade, Beograd, 11000, Serbia

RECRUITING

Clinical Hospital Center - Bežanijska Kosa /ID# 270558

Belgrade, Beograd, 11080, Serbia

RECRUITING

University Clinical Center Nis /ID# 270557

Niš, Nisavski Okrug, 18300, Serbia

RECRUITING

Institute For Pulmonary Diseases Of Vojvodina /ID# 270559

Kamenitz, Sremski Okrug, 21208, Serbia

RECRUITING

University Clinical Center Kragujevac /ID# 275773

Kragujevac, Sumadijski Okrug, 34000, Serbia

RECRUITING

National Cancer Centre Singapore /ID# 271499

Singapore, Central Singapore, 169611, Singapore

RECRUITING

National University Hospital /ID# 271700

Singapore, 119074, Singapore

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

telisotuzumab vedotin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 23, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CN (8); SG (2); US (35); IL (4); JP (9); SE (6)