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)

Part of paid clinical trials in Chandler, Arizona.

Sponsor
AbbVie
Study ID
NCT06568939
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 80 to 90 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.

Key Dates

Start date
Jan 20, 2025
Status verified
Jun 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telisotuzumab Vedotin Dose A
    Participants will receive telisotuzumab vedotin dose A, as part of the 3 year study duration.
  • Experimental: Telisotuzumab Vedotin Dose B
    Participants will receive telisotuzumab vedotin dose B, as part of the 3 year study duration.
  • Experimental: Telisotuzumab Vedotin Dose C
    Participants will receive telisotuzumab vedotin dose C, as part of the 3 year study duration.

Primary Outcome Measure

Percentage of Participants with Treatment-Emergent Adverse Events (AE)s (Any-grade and Grade >= 2) [ Time Frame: Up to Approximately 3 Years ]

Central Contacts

Locations (38)

FacilityCityStateZIPSite coordinators
Ironwood Cancer and Research Center /ID# 276370ChandlerArizona85224-
University of Arkansas for Medical Sciences /ID# 272923Little RockArkansas72205-
Valkyrie Clinical Trials /ID# 271322Los AngelesCalifornia90067-
Yale New Haven Hospital /ID# 271584New HavenConnecticut06510-
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899JacksonvilleFlorida32256-
Ocala Oncology Center /ID# 273697OcalaFlorida34474-
Memorial Hospital West /ID# 270313Pembroke PinesFlorida33028-
Comprehensive Hematology Oncology /ID# 270422St. PetersburgFlorida33701-4732-
Florida Cancer Specialists - North /ID# 271995St. PetersburgFlorida33705-
Florida Cancer Specialists - East /ID# 271993West Palm BeachFlorida33401-
University Cancer & Blood Center /ID# 270969AthensGeorgia30607-
Northwest Georgia Oncology Centers /ID# 275374MariettaGeorgia30060-
Memorial University Medical Center /ID# 272467SavannahGeorgia31404-
Kaiser Permanente Moanalua Medical Center /ID# 272916HonoluluHawaii96819-
University of Illinois Hospital and Health Sciences System /ID# 275345ChicagoIllinois60607-
Illinois Cancer Specialists /ID# 274678NilesIllinois60714-
Springfield Clinic - First /ID# 272576SpringfieldIllinois62702-
NHO - Nebraska Hematology-Oncology /ID# 272970LincolnNebraska68506-
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271527OmahaNebraska68130-
Renown Regional Medical Center /ID# 273535RenoNevada89502-
Astera Cancer Care /ID# 272359East BrunswickNew Jersey08816-4096-
Regional Cancer Care Associates /ID# 270783TeaneckNew Jersey07666-
Montefiore Medical Center - Einstein Campus /ID# 277169The BronxNew York10461-
Clinical Research Alliance - Westbury /ID# 270455WestburyNew York11590-
FirstHealth of the Carolinas- Speciality Center /ID# 272924PinehurstNorth Carolina28374-
Mercy Health - Perrysburg Cancer Center /ID# 270536PerrysburgOhio43551-
Genesis Healthcare System /ID# 273361ZanesvilleOhio43701-
Guthrie Robert Packer Hospital /ID# 270316SayrePennsylvania18840-
Cancer Care Associates Of York /ID# 270971YorkPennsylvania17403-
Medical University of South Carolina /ID# 273272CharlestonSouth Carolina29425-
Saint Francis Cancer Center - Greenville /ID# 276368GreenvilleSouth Carolina29607-
SCRI Oncology Partners /ID# 270162NashvilleTennessee37203-
Texas Oncology - Dallas - Worth Street /ID# 278947DallasTexas75246-
Texas Oncology - Northeast Texas /ID# 272000TylerTexas75702-
Community Cancer Trials Of Utah /ID# 276598OgdenUtah84405-
Virginia Cancer Specialists - Fairfax /ID# 272004FairfaxVirginia22031-
Medical Oncology Associates - Spokane /ID# 277172SpokaneWashington99208-
Northwest Medical Specialties Tacoma /ID# 270534TacomaWashington98405-

Find similar trials in Chandler, AZ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Ironwood Cancer and Research Center· Chandler, AZUniversity of Arkansas for Medical Sciences· Little Rock, ARValkyrie Clinical Trials· Los Angeles, CAYale New Haven Hospital· New Haven, CTCancer Specialists of North Florida - Jacksonville - AC Skinner Parkway· Jacksonville, FLOcala Oncology Center· Ocala, FL

Related Studies