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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Telisotuzumab Vedotin: Intravenous (IV) Infusion
Docetaxel: IV Infusion
Study summary
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 telisotuzumab vedotin or docetaxel at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 768 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.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) — Up to approximately 39 months
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per BICR or death from any cause. - Overall Survival (OS) — Up to approximately 39 months
OS is defined as the time from randomization to the event of death from any cause.
Trial sites (317)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham - Main /ID# 247074 | Birmingham | Alabama | Completed |
| Ironwood Cancer & Res Ctr /ID# 262446 | Chandler | Arizona | Active Not Recruiting |
| Mayo Clinic Arizona /ID# 255858 | Phoenix | Arizona | Active Not Recruiting |
| Onvida Health Yuma Medical Center /ID# 253625 | Yuma | Arizona | Completed |
| City of Hope /ID# 243157 | Duarte | California | Recruiting |
| City Of Hope - Seacliff /ID# 263143 | Huntington Beach | California | Recruiting |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144 | Irvine | California | Recruiting |
| City Of Hope - Antelope Valley /ID# 263138 | Lancaster | California | Recruiting |
| The Oncology Institute Of Hope & Innovation -East Los A /ID# 239774 | Los Angeles | California | Completed |
| Eisenhower Medical Center /ID# 233189 | Rancho Mirage | California | Completed |
| Premiere Oncology Foundation /ID# 253954 | Santa Monica | California | Completed |
| Mayo Clinic Hospital Jacksonville /ID# 254688 | Jacksonville | Florida | Completed |
| Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228 | Ocala | Florida | Completed |
| BRCR Medical Center Inc /ID# 262344 | Tamarac | Florida | Completed |
| Memorial University Medical Center /ID# 264081 | Savannah | Georgia | Completed |
| Kaiser Permanente Moanalua Medical Center /ID# 238363 | Honolulu | Hawaii | Recruiting |
| Edward-Elmhurst Cancer Center /ID# 238552 | Elmhurst | Illinois | Active Not Recruiting |
| Springfield Clinic - First /ID# 262290 | Springfield | Illinois | Active Not Recruiting |
| Goshen Center for Cancer Care /ID# 257734 | Goshen | Indiana | Completed |
| Investigative Clinical Research of Indiana - Indianapolis /ID# 260468 | Indianapolis | Indiana | Completed |
| Baptist Health Lexington /ID# 252769 | Lexington | Kentucky | Completed |
| Dana-Farber Cancer Institute /ID# 247132 | Boston | Massachusetts | Completed |
| Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190 | Ypsilanti | Michigan | Completed |
| Mayo Clinic - Rochester /ID# 252052 | Rochester | Minnesota | Active Not Recruiting |
| Hattiesburg Clinic /ID# 248033 | Hattiesburg | Mississippi | Recruiting |
| St. Luke's Hospital - Chesterfield /ID# 251688 | Chesterfield | Missouri | Completed |
| St. Lukes Hosp. of Kansas City /ID# 259940 | Kansas City | Missouri | Recruiting |
| Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567 | Kansas City | Missouri | Completed |
| Hulston Cancer Center /ID# 232226 | Springfield | Missouri | Recruiting |
| Saint Louis University Cancer Center /ID# 260722 | St Louis | Missouri | Completed |
| Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147 | Billings | Montana | Active Not Recruiting |
| Nebraska Hematology Oncology /ID# 257710 | Lincoln | Nebraska | Completed |
| Renown Medical Group - Oncology/Hematology /ID# 247942 | Reno | Nevada | Completed |
| Astera Cancer Care /ID# 257753 | East Brunswick | New Jersey | Completed |
| San Juan Oncology Associates /ID# 244387 | Farmington | New Mexico | Completed |
| Maimonides Medical Center /ID# 240783 | Brooklyn | New York | Active Not Recruiting |
| Northwell Health - Monter Cancer Center /ID# 247081 | Lake Success | New York | Completed |
| AdventHealth Hendersonville /ID# 265349 | Hendersonville | North Carolina | Completed |
| FirstHealth of the Carolinas- Speciality Center /ID# 241279 | Pinehurst | North Carolina | Completed |
| Genesis Cancer Care Center /ID# 239190 | Zanesville | Ohio | Active Not Recruiting |
+ 277 more sites — see the full list on the official registry below.
More AbbVie trials in Italy
Other trials for the same condition
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 NCT04928846 on ClinicalTrials.gov ↗ ← All trials in Italy