Clinical Trials /

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

NCT03539536

Description:

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).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: M14-239
  • NCT ID: NCT03539536

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
Telisotuzumab vedotinABBV-399Telisotuzumab vedotin

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Telisotuzumab vedotinExperimentalTelisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.
  • Telisotuzumab vedotin

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:ORR is defined as the proportion of subjects with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1

Secondary Outcome Measures

Measure:Duration of Response (DoR)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:DoR is defined as the time from the subject's initial response (CR or PR) to the first occurrence of radiographic progression determined by an independent central review or death from any cause for the responders.
Measure:Disease Control Rate (DCR)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:DCR is defined as the percentage of subjects with best overall response of confirmed CR, confirmed PR, or stable disease (SD) based on RECIST, version 1.1.
Measure:Duration of Disease Control (DDC)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:DDC is defined as the time from the initial subject's response of SD, PR, or CR to the first occurrence of radiographic progression determined by an independent central review or death from any cause.
Measure:Progression-Free Survival (PFS)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:PFS is defined as the time from the subject's first dose of study drug until the first occurrence of radiographic progression determined by an independent central review or death from any cause.
Measure:Overall Survival (OS)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:OS is defined as the time from the subject's first dose of study drug until death from any cause.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Non-small Cell Lung Cancer (NSCLC)
  • Cancer
  • Telisotuzumab vedotin
  • ABBV-399
  • c-Met, c-Met overexpression
  • metastatic

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