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

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).

Key Eligibility:

Inclusion Criteria:
• 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 or is ineligible for treatment with platinum-based chemotherapy doublet, and/or an immune checkpoint inhibitor, or EGFR Tyrosine Kinase Inhibitor (TKI).
• Has received no more than 2 lines of prior systemic therapy in the metastatic setting.
• Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Exclusion Criteria:
• 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.
Phase II
Rachel Sanborn, M.D.
AbbVie Inc
Brenda Fisher
  • Providence Cancer Institute Franz Clinic