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

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ClinicalTrials.gov Identifier: NCT03539536
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief 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).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Telisotuzumab vedotin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : October 27, 2021
Estimated Study Completion Date : October 9, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Telisotuzumab vedotin
Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.
Drug: Telisotuzumab vedotin
intravenous
Other Name: ABBV-399




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]
    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 :
  1. Duration of Response (DoR) [ Time Frame: Up to approximately 3 years ]
    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.

  2. Disease Control Rate (DCR) [ Time Frame: Up to approximately 3 years ]
    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.

  3. Duration of Disease Control (DDC) [ Time Frame: Up to approximately 3 years ]
    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.

  4. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 3 years ]
    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.

  5. Overall Survival (OS) [ Time Frame: Up to approximately 3 years ]
    OS is defined as the time from the subject's first dose of study drug until death from any cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539536


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03539536     History of Changes
Other Study ID Numbers: M14-239
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Non-small Cell Lung Cancer (NSCLC)
Cancer
Telisotuzumab vedotin
ABBV-399
c-Met, c-Met overexpression
metastatic

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs