Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

Part of paid clinical trials in Mobile, Alabama.

Sponsor
AbbVie
Study ID
NCT03539536
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3).

Key Dates

Start date
Oct 10, 2018
Status verified
Nov 2025
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
270 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Telisotuzumab vedotin
    Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.

Primary Outcome Measure

Overall Response Rate (ORR) (Stage 1 and Stage 2) [ Time Frame: Up to approximately 3 years ]

Locations (56)

FacilityCityStateZIPSite coordinators
University of South Alabama /ID# 212939MobileAlabama36604-3302-
Mayo Clinic Arizona /ID# 218550PhoenixArizona85054-4504-
Highlands Oncology Group, PA /ID# 215600SpringdaleArkansas72762-
University of California, Los Angeles /ID# 203219Los AngelesCalifornia90095-
LA Hematology-Oncology Med Group /ID# 203338OrangeCalifornia92868-
Sutter Medical Center Sacramen /ID# 203299SacramentoCalifornia95816-
Icri /Id# 227835WhittierCalifornia90603-
Univ of Colorado Cancer Center /ID# 203212AuroraColorado80045-
Duplicate_Rocky Mountain Cancer Centers - Lone Tree /ID# 215789Lone TreeColorado80124-
Advanced Cancer Treatment Center /ID# 239565BrooksvilleFlorida34613-6072-
AdventHealth Celebration /ID# 215649CelebrationFlorida34747-4970-
Duplicate_Mayo Clinic /ID# 218488JacksonvilleFlorida32224-
Duplicate_AdventHealth Cancer Institute - Orlando /ID# 239960OrlandoFlorida32804-
Straub Clinic and Hospital /ID# 217905HonoluluHawaii96813-3097-
Northwestern University Feinberg School of Medicine /ID# 203239ChicagoIllinois60611-2927-
The University of Chicago Medical Center /ID# 203216ChicagoIllinois60637-1443-
Duplicate_NorthShore University HealthSystem /ID# 215583EvanstonIllinois60201-
Ingalls Memorial Hosp /ID# 203228HarveyIllinois60426-
Joliet Oncology-Hematology Associates, LTD /ID# 203238JolietIllinois60435-
Goshen Center for Cancer Care /ID# 215584GoshenIndiana46526-
Univ Kansas Med Ctr /ID# 216804Kansas CityKansas66160-
Cancer Center of Kansas /ID# 203235WichitaKansas67214-
Duplicate_Baptist Health /ID# 203283LexingtonKentucky40503-1463-
Duplicate_Norton Cancer Institute - St Matthews /ID# 203284LouisvilleKentucky40207-
Central Maine Medical Center /ID# 216583LewistonMaine04240-
Beth Israel Deaconess Medical Center /ID# 208124BostonMassachusetts02215-5400-
Dana-Farber Cancer Institute /ID# 203248BostonMassachusetts02215-
Massachusetts General Hospital /ID# 203215BostonMassachusetts02114-
Henry Ford Hospital /ID# 203220DetroitMichigan48202-
Mayo Clinic - Rochester /ID# 215603RochesterMinnesota55905-0001-
Hattiesburg Clinic /ID# 227691HattiesburgMississippi39401-
St. Lukes Cancer Institute /ID# 227697Kansas CityMissouri64111-5905-
Washington University-School of Medicine /ID# 203217St LouisMissouri63110-
Duplicate_Intermountain Health - St Vincent Regional Hospital - Cancer Centers o /ID# 203292BillingsMontana59102-
Duplicate_Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 203350LebanonNew Hampshire03756-
Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 228868East BrunswickNew Jersey08816-
Atlantic Health System /ID# 203404MorristownNew Jersey07960-6136-
Capital Health Medical Center /ID# 203403PenningtonNew Jersey08534-2520-
Overlook Medical Center /ID# 211160SummitNew Jersey07901-3533-
University of New Mexico /ID# 208339AlbuquerqueNew Mexico87102-4517-
Duplicate_Gabrail Cancer Center Research /ID# 216056CantonOhio44718-
Univ Hosp Cleveland /ID# 215648ClevelandOhio44106-
Mercy Cancer Center /ID# 231972ElyriaOhio44024-
Mercy Research Mercy Clinic Oklahoma Communities, Inc. / OKC /ID# 230154Oklahoma CityOklahoma73120-
Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301PortlandOregon97225-
Penn State University and Milton S. Hershey Medical Center /ID# 221844HersheyPennsylvania17033-2360-
Duplicate_Allegheny General Hospital /ID# 215585PittsburghPennsylvania15212-
Veterans Healthcare System /ID# 215602PittsburghPennsylvania15240-
Thompson Cancer Survival Ctr /ID# 228874KnoxvilleTennessee37916-
Vanderbilt Ingram Cancer Center /ID# 203281NashvilleTennessee37232-0021-
Houston Methodist Hospital /ID# 213268HoustonTexas77030-
Baylor Scott & White Medical Center- Temple /ID# 216578TempleTexas76508-0001-
Virginia Cancer Specialists - Fairfax /ID# 203224FairfaxVirginia22031-
Valley Medical Center /ID# 231459RentonWashington98055-5738-
University of Washington /ID# 206056SeattleWashington98109-
Wisconsin Medical Center /ID# 210062MilwaukeeWisconsin53226-

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