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)

Description

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

Study Overview

Study Details

Study overview

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.

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

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)

Condition
Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Jacksonville

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

Saint Petersburg

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

Springfield

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

Omaha

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

East Brunswick

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

Westbury

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

Pinehurst

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

Zanesville

Genesis Healthcare System /ID# 273361, Zanesville, Ohio, United States, 43701

Sayre

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

York

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2028-02