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)

Purpose

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.

Condition

  • Non-Small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Ironwood Cancer & Research Center /ID# 276370
Chandler 5289282, Arizona 5551752 85224

Valkyrie Clinical Trials /ID# 271322
Los Angeles 5368361, California 5332921 90067

Yale New Haven Hospital /ID# 271584
New Haven 4839366, Connecticut 4831725 06510

Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899
Jacksonville 4160021, Florida 4155751 32256

Ocala Oncology Center /ID# 273697
Ocala 4166673, Florida 4155751 34474

Comprehensive Hematology Oncology /ID# 270422
St. Petersburg 4171563, Florida 4155751 33701-4732

Florida Cancer Specialists - North /ID# 271995
St. Petersburg 4171563, Florida 4155751 33705

Florida Cancer Specialists - East /ID# 271993
West Palm Beach 4177887, Florida 4155751 33401

University Cancer & Blood Center /ID# 270969
Athens 4180386, Georgia 4197000 30607

Northwest Georgia Oncology Centers /ID# 275374
Marietta 4207783, Georgia 4197000 30060

Memorial University Medical Center /ID# 272467
Savannah 4221552, Georgia 4197000 31404

Kaiser Permanente Moanalua Medical Center /ID# 272916
Honolulu 5856195, Hawaii 5855797 96819

University of Illinois Hospital and Health Sciences System /ID# 275345
Chicago 4887398, Illinois 4896861 60607

Illinois Cancer Specialists /ID# 274678
Niles 4903730, Illinois 4896861 60714

Springfield Clinic - First /ID# 272576
Springfield 4250542, Illinois 4896861 62702

NHO - Nebraska Hematology-Oncology /ID# 272970
Lincoln 5072006, Nebraska 5073708 68506

Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527
Omaha 5074472, Nebraska 5073708 68130

Renown Regional Medical Center /ID# 273535
Reno 5511077, Nevada 5509151 89502

Astera Cancer Care /ID# 272359
East Brunswick 5097402, New Jersey 5101760 08816-4096

Montefiore Medical Center /ID# 277169
The Bronx 5110266, New York 5128638 10461

Clinical Research Alliance - Westbury /ID# 270455
Westbury 5144040, New York 5128638 11590

FirstHealth of the Carolinas- Speciality Center /ID# 272924
Pinehurst 4485272, North Carolina 4482348 28374

Mercy Health - Perrysburg Cancer Center /ID# 270536
Perrysburg 5166516, Ohio 5165418 43551

Genesis Healthcare System /ID# 273361
Zanesville 4528923, Ohio 5165418 43701

Guthrie Robert Packer Hospital /ID# 270316
Sayre 5211037, Pennsylvania 6254927 18840

Cancer Care Associates Of York /ID# 270971
York 4562407, Pennsylvania 6254927 17403

Saint Francis Cancer Center - Greenville /ID# 276368
Greenville 4580543, South Carolina 4597040 29607

SCRI Oncology Partners /ID# 270162
Nashville 4644585, Tennessee 4662168 37203

Texas Oncology - Northeast Texas /ID# 272000
Tyler 4738214, Texas 4736286 75702

Community Cancer Trials Of Utah /ID# 276598
Ogden 5779206, Utah 5549030 84405

Virginia Cancer Specialists - Fairfax /ID# 272004
Fairfax 4758023, Virginia 6254928 22031

Medical Oncology Associates - Spokane /ID# 277172
Spokane 5811696, Washington 5815135 99208

Northwest Medical Specialties Tacoma /ID# 270534
Tacoma 5812944, Washington 5815135 98405

More Details

NCT ID
NCT06568939
Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center