Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
estimated completion

Description

Summary

This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express 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).

Official Title

Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer Non-small Cell Lung Cancer (NSCLC) Cancer Telisotuzumab vedotin ABBV-399 c-Met, c-Met overexpression metastatic MET gene amplification Lung Neoplasms Carcinoma, Non-Small-Cell Lung

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed non-squamous cell non-small cell lung cancer (NSCLC) with known epidermal growth factor receptor (EGFR) status (wild type or mutant; with site documented status), or histologically documented squamous cell NSCLC. Of note, subjects with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met.
  • Has locally advanced or metastatic NSCLC.
  • Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory or known documented MET gene amplification.
  • If a subject meets eligibility criteria for c-Met protein expression level based on archival tissue material, or MET amplification status, subject must agree to submit tumor material for assessment of c-Met protein expression level prior to enrollment.
  • Has progressed on systemic cytotoxic therapy (or ineligible), and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible) and prior anti-cancer therapies targeting driver gene alterations (if applicable).
  • Have received no more than 2 lines of prior systemic chemotherapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the metastatic setting.
  • Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same gene alteration count as 1 line of therapy for the purposes of this eligibility criterion.
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

You CAN'T join if...

  • Has adenosquamous histology.
  • Subjects with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy).
  • Has a clinically significant condition(s) described in the protocol.
  • Has unresolved clinically significant adverse events >= grade 2 from prior anticancer therapy, except for alopecia or anemia.
  • Had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
  • Has received live vaccine within 30 days of the first dose of telisotuzumab vedotin.
  • Subjects do not have a history of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis.

Locations

  • UCSD Moores Cancer Center - LaJolla /ID# 218258 not yet accepting patients
    La Jolla California 92093 United States
  • University of California, Los Angeles /ID# 203219 accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03539536
Phase
Phase 2
Study Type
Interventional
Last Updated