RECRUITING

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)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-20
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06568939

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Projected life expectancy of at least 12 weeks.
  2. * Must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory
  3. * Must have histologically or cytologically documented NSCLC that is locally advanced or metastatic.
  4. * Must have a known epidermal growth factor receptor (EGFR) activating mutation status.
  5. * Actionable alterations in genes other than EGFR are permitted.
  6. * Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  7. * Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  8. * 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.
  9. * Must have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC, as stated in the protocol.
  1. * Adenosquamous or neuroendocrine histology, or sarcomatoid features.
  2. * Actionable EGFR activating mutations.
  3. * Received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E.
  4. * Received prior docetaxel therapy.
  5. * 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.
  6. * History of other malignancies except those stated in the protocol.
  7. * 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.
  8. * 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.
  9. * Major surgery within 21 days prior to randomization.
  10. * Clinically significant condition(s) including but not limited to those listed in the protocol.
  11. * Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis.
  12. * Grade \>= 2 edema or lymphedema.
  13. * Grade \>= 2 ascites or pleural effusion.
  14. * Grade \>= 2 neuropathy.
  15. * Active uncontrolled bacterial or viral infection.
  16. * Active corneal disorder.

Contacts and Locations

Study Contact

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

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899
Jacksonville, Florida, 32256
United States
Comprehensive Hematology Oncology /ID# 270422
Saint Petersburg, Florida, 33701-4732
United States
Springfield Clinic /ID# 272576
Springfield, Illinois, 62702-3749
United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527
Omaha, Nebraska, 68130
United States
Astera Cancer Care /ID# 272359
East Brunswick, New Jersey, 08816-4096
United States
Clinical Research Alliance - Westbury /ID# 270455
Westbury, New York, 11590
United States
FirstHealth of the Carolinas- Speciality Center /ID# 272924
Pinehurst, North Carolina, 28374
United States
Genesis Healthcare System /ID# 273361
Zanesville, Ohio, 43701
United States
Guthrie Robert Packer Hospital /ID# 270316
Sayre, Pennsylvania, 18840
United States
Cancer Care Associates Of York /ID# 270971
York, Pennsylvania, 17403
United States
SCRI Oncology Partners /ID# 270162
Nashville, Tennessee, 37203
United States
Texas Oncology - Northeast Texas /ID# 272000
Tyler, Texas, 75702
United States
Virginia Cancer Specialists - Fairfax /ID# 272004
Fairfax, Virginia, 22031
United States
Northwest Medical Specialties Tacoma /ID# 270534
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-20
Study Completion Date2028-02

Study Record Updates

Study Start Date2025-01-20
Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Non-Small Cell Lung Cancer