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Clinical Trials in Ireland / NCT03539536
Active, not recruiting Phase 2

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

NCT03539536 · tracked via the Priya Life Science Ireland tracker
Sponsor
AbbVie
Phase
Phase 2
Started
2018-10-10
Last updated
2025-11-05

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Telisotuzumab vedotin

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Have locally advanced or metastatic non-small cell lung cancer (NSCLC). * Have c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory. Participant must submit archival or fresh tumor material for assessment of c-Met levels during the prescreening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. If archival tissue is negative for c-Met overexpression, subject can submit fresh biopsy material for reassessment of c-Met expression. * Histologically documented non-squamous epidermal growth factor receptor (EGFR) wild type NSCLC (site documented EGFR status). Of note, subjects with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met. As of Protocol Version 11, Stage 1 is complete and Stage 2 is enrolling participants with non-squamous EGFR wild type NSCLC only. * Must have received no more than 2 lines of prior systemic therapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic setting. * Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same tyrosine kinase (TK) count as 1 line of therapy for the purposes of this eligibility criterion. * Progressed on systemic cytotoxic therapy (or are ineligible for systemic cytotoxic chemotherapy) and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible), and prior anticancer therapies targeting driver gene alterations (if applicable). * Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. * Treatment with any therapies within the noted time intervals is excluded prior to the first dose of telisotuzumab vedotin as noted in the protocol. * Metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided within the protocol. Exclusion Criteria: * Have received radiation therapy to the lungs \< 6 months prior to the first dose of telisotuzumab vedotin. * Have received any live vaccine within 30 days of the first dose of investigational product. * Has adenosquamous histology. * Have a history of other malignancies except those noted within the protocol. * Have a history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids. * Have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD within 3 months of the planned first dose of the study drug (Except for Sites in Ireland). For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor. * For Sites in Ireland Only: Must not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD. For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor. * Have a clinically significant condition(s) as noted in the protocol. * Have unresolved clinically significant adverse events of Grade \>= 2 from prior anticancer therapy, except for alopecia or anemia. * Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin. * For Sites in France and Czech Republic Only: Have the following: * Known human immunodeficiency virus (HIV) infection. Note: HIV testing is not required for eligibility for this protocol unless mandated by local regulatory authority or ethics committee/institutional review board. * Active hepatitis B virus (HBV) infection, defined by hepatitis B surface antigen (HBsAg) positivity or HBV DNA \>= 500 IU/mL. In participants with known HBV infection, the presence of active infection must be tested locally. If HBV status is unknown, it must be tested locally at screening. * Active hepatitis C virus (HCV) infection, defined by HCV ribonucleic acid (RNA) positivity. Participants cured of HCV infection may be included in the study. In participants with known HCV infection, the presence of active infection must be tested locally. If HCV status is unknown, it must be tested locally at screening. * Uncontrolled autoimmune disease.

Primary outcome measure(s)

Trial sites (252)

FacilityCityRegionStatus
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.

More AbbVie trials in Ireland

Other trials for the same condition

Official registry record

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 Ireland