RecruitingPhase 2NCT06568939

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, 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

Sponsor

AbbVie

Enrollment

150 participants

Start Date

Jan 20, 2025

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests telisotuzumab vedotin (ABBV-399), an antibody-drug combination delivered by IV infusion, in people with advanced non-squamous non-small cell lung cancer (NSCLC) whose cancer overexpresses a protein called c-Met. The drug works by targeting c-Met on cancer cells to deliver a chemotherapy agent directly to the tumor. **You may be eligible if:** - You have advanced or metastatic non-squamous NSCLC (a type of lung cancer) - Your tumor tests positive for high c-Met protein expression (confirmed by a specific lab test) - You have a known EGFR mutation status - You have received no more than 1 line of prior chemotherapy for advanced disease - You are in good general health (ECOG score 0 or 1) with a life expectancy of at least 12 weeks - Your disease can be measured on imaging scans **You may NOT be eligible if:** - Your cancer does not overexpress c-Met - You have had more than 1 prior chemotherapy regimen for advanced disease - Your general health is too poor for treatment - You have severe organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTelisotuzumab Vedotin

Intravenous (IV) Infusion

Locations(64)

Ironwood Cancer & Research Center /ID# 276370

Chandler, Arizona, United States

University of Arkansas for Medical Sciences /ID# 272923

Little Rock, Arkansas, United States

Valkyrie Clinical Trials /ID# 271322

Los Angeles, California, United States

Yale New Haven Hospital /ID# 271584

New Haven, Connecticut, United States

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

Jacksonville, Florida, United States

Ocala Oncology Center /ID# 273697

Ocala, Florida, United States

Comprehensive Hematology Oncology /ID# 270422

St. Petersburg, Florida, United States

Florida Cancer Specialists - North /ID# 271995

St. Petersburg, Florida, United States

Florida Cancer Specialists - East /ID# 271993

West Palm Beach, Florida, United States

University Cancer & Blood Center /ID# 270969

Athens, Georgia, United States

Northwest Georgia Oncology Centers /ID# 275374

Marietta, Georgia, United States

Memorial University Medical Center /ID# 272467

Savannah, Georgia, United States

Kaiser Permanente Moanalua Medical Center /ID# 272916

Honolulu, Hawaii, United States

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

Chicago, Illinois, United States

Illinois Cancer Specialists /ID# 274678

Niles, Illinois, United States

Springfield Clinic - First /ID# 272576

Springfield, Illinois, United States

NHO - Nebraska Hematology-Oncology /ID# 272970

Lincoln, Nebraska, United States

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

Omaha, Nebraska, United States

Renown Regional Medical Center /ID# 273535

Reno, Nevada, United States

Astera Cancer Care /ID# 272359

East Brunswick, New Jersey, United States

Montefiore Medical Center /ID# 277169

The Bronx, New York, United States

Clinical Research Alliance - Westbury /ID# 270455

Westbury, New York, United States

FirstHealth of the Carolinas- Speciality Center /ID# 272924

Pinehurst, North Carolina, United States

Mercy Health - Perrysburg Cancer Center /ID# 270536

Perrysburg, Ohio, United States

Genesis Healthcare System /ID# 273361

Zanesville, Ohio, United States

Guthrie Robert Packer Hospital /ID# 270316

Sayre, Pennsylvania, United States

Cancer Care Associates Of York /ID# 270971

York, Pennsylvania, United States

Medical University of South Carolina /ID# 273272

Charleston, South Carolina, United States

Saint Francis Cancer Center - Greenville /ID# 276368

Greenville, South Carolina, United States

SCRI Oncology Partners /ID# 270162

Nashville, Tennessee, United States

Texas Oncology - Northeast Texas /ID# 272000

Tyler, Texas, United States

Community Cancer Trials Of Utah /ID# 276598

Ogden, Utah, United States

Virginia Cancer Specialists - Fairfax /ID# 272004

Fairfax, Virginia, United States

Medical Oncology Associates - Spokane /ID# 277172

Spokane, Washington, United States

Northwest Medical Specialties Tacoma /ID# 270534

Tacoma, Washington, United States

Beijing Chest Tumor Hospital /ID# 271935

Beijing, Beijing Municipality, China

Affiliated Cancer Hospital of Guangxi Medical University /ID# 271931

Nanning, Guangxi, China

Henan Cancer Hospital /ID# 271927

Zhengzhou, Henan, China

Union Hospital - Tongji Medical College /ID# 271668

Wuhan, Hubei, China

The First Affiliated Hospital of Nanchang University /ID# 271666

Nanchang, Jiangxi, China

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

Xi'an, Shaanxi, China

Linyi Cancer Hospital /ID# 272068

Linyi, Shandong, China

Cancer Hospital Affliated to Xinjiang Medical University /ID# 271933

Ürümqi, Xinjiang, China

Meir Medical Center /ID# 270071

Kfar Saba, Central District, Israel

Rambam Health Care Campus- Haifa /ID# 270078

Haifa, Israel

Shaare Zedek Medical Center /ID# 270095

Jerusalem, Israel

Rabin Medical Center. /ID# 270087

Petah Tikva, Israel

Nagoya University Hospital /ID# 277010

Nagoya, Aichi-ken, Japan

Hokkaido University Hospital /ID# 277014

Sapporo, Hokkaido, Japan

Kobe Minimally Invasive Cancer Center /ID# 277469

Kobe, Hyōgo, Japan

Kitasato University Hospital /ID# 277012

Sagamihara-shi, Kanagawa, Japan

Sendai Kousei Hospital /ID# 277023

Sendai, Miyagi, Japan

University of Miyazaki Hospital /ID# 277020

Miyazaki, Miyazaki, Japan

Kurashiki Central Hospital /ID# 276995

Kurashiki-shi, Okayama-ken, Japan

Fujieda Municipal General Hospital /ID# 277025

Fujieda, Shizuoka, Japan

Wakayama Medical University Hospital /ID# 276997

Wakayama, Wakayama, Japan

Institute for Oncology and Radiology of Serbia /ID# 270561

Belgrade, Beograd, Serbia

University Clinical Center Serbia /ID# 270808

Belgrade, Beograd, Serbia

Clinical Hospital Center - Bežanijska Kosa /ID# 270558

Belgrade, Beograd, Serbia

University Clinical Center Nis /ID# 270557

Niš, Nisavski Okrug, Serbia

Institute For Pulmonary Diseases Of Vojvodina /ID# 270559

Kamenitz, Sremski Okrug, Serbia

University Clinical Center Kragujevac /ID# 275773

Kragujevac, Sumadijski Okrug, Serbia

National Cancer Centre Singapore /ID# 271499

Singapore, Central Singapore, Singapore

National University Hospital /ID# 271700

Singapore, Singapore

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NCT06568939