Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Telisotuzumab vedotin: Intravenous (IV) infusion
Study summary
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).
Eligibility
Primary outcome measure(s)
- Overall Response Rate (ORR) (Stage 1 and Stage 2) — Up to approximately 3 years
ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. - Number of Participants with Adverse Events (Alternate dose cohort) — Up to approximately 3 years
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Trial sites (252)
| Facility | City | Region | Status |
|---|---|---|---|
| University of South Alabama /ID# 212939 | Mobile | Alabama | |
| Mayo Clinic Arizona /ID# 218550 | Phoenix | Arizona | |
| Highlands Oncology Group, PA /ID# 215600 | Springdale | Arkansas | |
| University of California, Los Angeles /ID# 203219 | Los Angeles | California | |
| LA Hematology-Oncology Med Group /ID# 203338 | Orange | California | |
| Sutter Medical Center Sacramen /ID# 203299 | Sacramento | California | |
| Icri /Id# 227835 | Whittier | California | |
| Univ of Colorado Cancer Center /ID# 203212 | Aurora | Colorado | |
| Duplicate_Rocky Mountain Cancer Centers - Lone Tree /ID# 215789 | Lone Tree | Colorado | |
| Advanced Cancer Treatment Center /ID# 239565 | Brooksville | Florida | |
| AdventHealth Celebration /ID# 215649 | Celebration | Florida | |
| Duplicate_Mayo Clinic /ID# 218488 | Jacksonville | Florida | |
| Duplicate_AdventHealth Cancer Institute - Orlando /ID# 239960 | Orlando | Florida | |
| Straub Clinic and Hospital /ID# 217905 | Honolulu | Hawaii | |
| Northwestern University Feinberg School of Medicine /ID# 203239 | Chicago | Illinois | |
| The University of Chicago Medical Center /ID# 203216 | Chicago | Illinois | |
| Duplicate_NorthShore University HealthSystem /ID# 215583 | Evanston | Illinois | |
| Ingalls Memorial Hosp /ID# 203228 | Harvey | Illinois | |
| Joliet Oncology-Hematology Associates, LTD /ID# 203238 | Joliet | Illinois | |
| Goshen Center for Cancer Care /ID# 215584 | Goshen | Indiana | |
| Univ Kansas Med Ctr /ID# 216804 | Kansas City | Kansas | |
| Cancer Center of Kansas /ID# 203235 | Wichita | Kansas | |
| Duplicate_Baptist Health /ID# 203283 | Lexington | Kentucky | |
| Duplicate_Norton Cancer Institute - St Matthews /ID# 203284 | Louisville | Kentucky | |
| Central Maine Medical Center /ID# 216583 | Lewiston | Maine | |
| Massachusetts General Hospital /ID# 203215 | Boston | Massachusetts | |
| Beth Israel Deaconess Medical Center /ID# 208124 | Boston | Massachusetts | |
| Dana-Farber Cancer Institute /ID# 203248 | Boston | Massachusetts | |
| Henry Ford Hospital /ID# 203220 | Detroit | Michigan | |
| Mayo Clinic - Rochester /ID# 215603 | Rochester | Minnesota | |
| Hattiesburg Clinic /ID# 227691 | Hattiesburg | Mississippi | |
| St. Lukes Cancer Institute /ID# 227697 | Kansas City | Missouri | |
| Washington University-School of Medicine /ID# 203217 | St Louis | Missouri | |
| Duplicate_Intermountain Health - St Vincent Regional Hospital - Cancer Centers o /ID# 203292 | Billings | Montana | |
| Duplicate_Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 203350 | Lebanon | New Hampshire | |
| Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 228868 | East Brunswick | New Jersey | |
| Atlantic Health System /ID# 203404 | Morristown | New Jersey | |
| Capital Health Medical Center /ID# 203403 | Pennington | New Jersey | |
| Overlook Medical Center /ID# 211160 | Summit | New Jersey | |
| University of New Mexico /ID# 208339 | Albuquerque | New Mexico |
+ 212 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03539536 on ClinicalTrials.gov ↗ ← All trials in Italy