RECRUITING

A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel 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 determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. 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 Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 330 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. At the conclusion of the study, participants who continue to demonstrate clinical benefit may be eligible to receive study treatment via an extension of the study, a rollover study, or through another mechanism. 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 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Quick Facts

Study Start:2022-03-25
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04928846

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. * Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.
  3. * Archival or fresh tumor material must be submitted for assessment of c-Met protein expression levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.
  4. * If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
  5. * A histologically or cytologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
  6. * A known epidermal growth factor receptor (EGFR) activating mutation status.
  7. * Actionable alterations in genes other than EGFR are eligible.
  8. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  9. * An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  10. * Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
  11. * Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
  12. * Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC:
  13. * Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
  14. * Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase \[ALK\] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.
  15. * Participants with actionable gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
  16. * Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
  17. * Participants with metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery, radiotherapy, or drug therapy) is provided and:
  18. * They are asymptomatic and off or on a stable or reducing dose of systemic steroids (on no more than 10 mg per day \[QD\] prednisone or equivalent) and/or anticonvulsants for at least 2 weeks prior to randomization.
  1. * Evidence of new, untreated CNS metastases or progressing CNS metastases after treatment.
  2. * Evidence of leptomeningeal disease.
  3. * Participants with adenosquamous or neuroendocrine histology, nor sarcomatoid features.
  4. * Epidermal growth factor receptor (EGFR) activating mutations.
  5. * Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
  6. * Participants who have received prior docetaxel therapy.
  7. * A history of other malignancies except:
  8. * Malignancy treated with curative intent and with no known active disease present for \>=2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator. Additionally, participants must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomization..
  9. * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  10. * Adequately treated carcinoma in situ without current evidence of disease.
  11. * A 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. A history of prior radiation pneumonitis in the radiation field (fibrosis) is not permitted.
  12. * Unresolved or neuroendocrine histology, nor sarcomatoid features 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.
  13. * Major surgery within 21 days prior to randomization.
  14. * Clinically significant condition(s) as listed in the protocol.

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)

University of Alabama at Birmingham - Main /ID# 247074
Birmingham, Alabama, 35233
United States
Ironwood Cancer & Res Ctr /ID# 262446
Chandler, Arizona, 85224-5665
United States
Mayo Clinic Arizona /ID# 255858
Phoenix, Arizona, 85054-4504
United States
Onvida Health Yuma Medical Center /ID# 253625
Yuma, Arizona, 85364
United States
City of Hope /ID# 243157
Duarte, California, 91010
United States
City Of Hope - Seacliff /ID# 263143
Huntington Beach, California, 92648
United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144
Irvine, California, 92618
United States
City Of Hope - Antelope Valley /ID# 263138
Lancaster, California, 93534
United States
The Oncology Institute Of Hope & Innovation -East Los A /ID# 239774
Los Angeles, California, 90033
United States
University of California, Los Angeles /ID# 253954
Los Angeles, California, 90095
United States
Eisenhower Medical Center /ID# 233189
Rancho Mirage, California, 92270-3221
United States
Mayo Clinic Hospital Jacksonville /ID# 254688
Jacksonville, Florida, 32224
United States
Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228
Ocala, Florida, 34474-4445
United States
BRCR Medical Center Inc /ID# 262344
Tamarac, Florida, 33321-2919
United States
Memorial University Medical Center /ID# 264081
Savannah, Georgia, 31404
United States
Kaiser Permanente Moanalua Medical Center /ID# 238363
Honolulu, Hawaii, 96819-1469
United States
Edward-Elmhurst Cancer Center /ID# 238552
Elmhurst, Illinois, 60126
United States
Springfield Clinic - First /ID# 262290
Springfield, Illinois, 62702
United States
Goshen Center for Cancer Care /ID# 257734
Goshen, Indiana, 46526
United States
Investigative Clinical Research of Indiana - Indianapolis /ID# 260468
Indianapolis, Indiana, 46260
United States
Baptist Health Lexington /ID# 252769
Lexington, Kentucky, 40503
United States
Dana-Farber Cancer Institute /ID# 247132
Boston, Massachusetts, 02215
United States
Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190
Ypsilanti, Michigan, 48197-1051
United States
Mayo Clinic - Rochester /ID# 252052
Rochester, Minnesota, 55905-0001
United States
Hattiesburg Clinic /ID# 248033
Hattiesburg, Mississippi, 39401
United States
St. Luke's Hospital - Chesterfield /ID# 251688
Chesterfield, Missouri, 63017
United States
St. Lukes Hosp. of Kansas City /ID# 259940
Kansas City, Missouri, 64111
United States
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567
Kansas City, Missouri, 64114-4859
United States
Hulston Cancer Center /ID# 232226
Springfield, Missouri, 65807-5287
United States
Saint Louis University Cancer Center /ID# 260722
St Louis, Missouri, 63110-2539
United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147
Billings, Montana, 59102
United States
Nebraska Hematology Oncology /ID# 257710
Lincoln, Nebraska, 68506
United States
Renown Medical Group - Oncology/Hematology /ID# 247942
Reno, Nevada, 89502-1464
United States
Astera Cancer Care /ID# 257753
East Brunswick, New Jersey, 08816-4096
United States
San Juan Oncology Associates /ID# 244387
Farmington, New Mexico, 87401
United States
Maimonides Medical Center /ID# 240783
Brooklyn, New York, 11219
United States
Northwell Health - Monter Cancer Center /ID# 247081
Lake Success, New York, 11042
United States
AdventHealth Hendersonville /ID# 265349
Hendersonville, North Carolina, 28792
United States
FirstHealth of the Carolinas- Speciality Center /ID# 241279
Pinehurst, North Carolina, 28374
United States
Genesis Cancer Care Center /ID# 239190
Zanesville, Ohio, 43701-1406
United States
Cancer Care Associates Of York /ID# 266143
York, Pennsylvania, 17403
United States
Medical University of South Carolina /ID# 251383
Charleston, South Carolina, 29425
United States
St Francis Cancer Center /ID# 243596
Greenville, South Carolina, 29607-5253
United States
Avera Cancer Institute - Aberdeen /ID# 257759
Aberdeen, South Dakota, 57401
United States
Avera Cancer Institute /ID# 239635
Sioux Falls, South Dakota, 57105
United States
Duplicate_Memphis VA Medical Center /ID# 263250
Memphis, Tennessee, 38104
United States
Dell Seton Medical Center /ID# 247016
Austin, Texas, 78701
United States
Community Cancer Trials of Utah - South Ogden /ID# 262829
Ogden, Utah, 84405-7194
United States
Valley Medical Center /ID# 253950
Renton, Washington, 98055-5738
United States
Medical Oncology Associates /ID# 247003
Spokane, Washington, 99208
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 Date2022-03-25
Study Completion Date2028-03

Study Record Updates

Study Start Date2022-03-25
Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

  • c-Met Overexpressing Non-Small Cell Lung Cancer
  • c-Met NSCLC
  • Telisotuzumab Vedotin
  • ABBV-399
  • Docetaxel
  • Cancer
  • Non Small Cell Lung Cancer
  • NSCLC
  • TeliMET NSCLC-01
  • Teliso-V

Additional Relevant MeSH Terms

  • Non Small Cell Lung Cancer