Summary

for people ages 18 years and up (full criteria)
at UCLA
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 Lung Neoplasms Carcinoma, Non-Small-Cell Lung

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed 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.
  • Has locally advanced or metastatic NSCLC.
  • Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC)laboratory.
  • If a subject meets eligibility criteria for c-Met protein expression level based on archival tissue material, subject must agree to submit fresh tumor material for assessment of c-Met protein expression level prior to first dose of telisotuzumab vedotin
  • 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 gene alterations (if applicable).
  • Have received no more than 2 lines of prior systemic therapy (including no more than 1 line of prior systemic cytotoxic chemotherapy) in the metastatic setting.
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

You CAN'T join if...

  • Has received prior c-MET-targeted antibody based therapies.
  • Has adenosquamous histology.
  • Has received anti-cancer therapy including chemotherapy, radiation therapy,immunotherapy, biologic, or any investigational therapy as described in the protocol.
  • Has known uncontrolled metastases to the central nervous system (CNS). Subjects with brain metastases are eligible if they meet requirements described in the protocol.
  • 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 a history of interstitial lung disease or pneumonitis that required treatment with systemic steroids.

Locations

  • University of California, Los Angeles /ID# 203219 not yet accepting patients
    Los Angeles California 90095 United States
  • Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301 not yet accepting patients
    Portland Oregon 97225 United States

Details

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