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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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

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

Comprehensive Hematology Oncology /ID# 270422
Saint Petersburg, Florida 33701-4732

Springfield Clinic /ID# 272576
Springfield, Illinois 62702-3749

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

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

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

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

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

Genesis Healthcare System /ID# 273361
Zanesville, Ohio 43701

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

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

SCRI Oncology Partners /ID# 270162
Nashville, Tennessee 37203

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

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

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

More Details

NCT ID
NCT06568939
Status
Recruiting
Sponsor
AbbVie

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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