Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03539536
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539536
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : May 5, 2020
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: N/A
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 : August 16, 2023

Resource links provided by the National Library of Medicine


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) for at least 12 weeks following enrollment, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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-squamous cell 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. Of note, subjects with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met.
  • Has locally advanced or metastatic NSCLC.
  • Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory or known documented MET gene amplification.
  • If a subject meets eligibility criteria for c-Met protein expression level based on archival tissue material, or MET amplification status, subject must agree to submit tumor material for assessment of c-Met protein expression level prior to enrollment.
  • 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 driver gene alterations (if applicable).
  • Have received no more than 2 lines of prior systemic chemotherapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the metastatic setting.

    • Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same gene alteration count as 1 line of therapy for the purposes of this eligibility criterion.
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Exclusion Criteria:

  • Has adenosquamous histology.
  • Subjects with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy).
  • 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 received live vaccine within 30 days of the first dose of telisotuzumab vedotin.
  • Subjects do not have a history of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis.

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
Layout table for location contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Show Show 153 study locations
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03539536    
Other Study ID Numbers: M14-239
2018-001772-38 ( EudraCT Number )
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
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

Layout table for additional information
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
MET gene amplification
Additional relevant MeSH terms:
Layout table for MeSH terms
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