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

ABBVIE DEUTSCHLAND GMBH & CO. KG0 sites310 target enrollmentStarted: June 14, 2021Last updated: September 7, 2021

Study Overview

No summary available.

•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
•Subjects who have progressed on systemic cytotoxic chemotherapy (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).
•Subject must 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.
•Subjects should not have received prior cMET-targeted antibody-based therapies.
•Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 155
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 155

•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.
•Subject must not have a history of interstitial lung disease or pneumonitis that required treatment with systemic steroids.

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