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Study of Telisotuzumab Vedotin (ABBV-399) in Participants 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 17, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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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 : January 16, 2025
Estimated Study Completion Date : January 16, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]
    ORR is defined as the percentage of participants 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 participant'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 participants 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. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 3 years ]
    PFS is defined as the time from the participant's first dose of study drug until the first occurrence of radiographic progression determined by an independent central review or death from any cause.

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


Eligibility Criteria
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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-squamous cell non-small cell lung cancer (NSCLC) with known epidermal growth factor receptor (EGFR) status (wild type or mutant; with site documented status). Of note, participants 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. Participant must submit archival or fresh tumor material for assessment of c-Met levels during the pre-screening period. If archival tissue is c-Met negative, participant can submit fresh biopsy material for reassessment of c-Met expression.

  • Have received no more than 2 lines of prior systemic therapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the locally advanced or 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.
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

Exclusion Criteria:

  • Have received prior c-Met-targeted antibody-based therapies.
  • Has adenosquamous histology.
  • Participants 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.
  • History of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis.
  • Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
  • Participants do not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or interstitial lung disease within 3 months of the planned first dose of the study drug.
  • Participants must not have received radiation therapy to the lung <6 months prior to the first dose of telisotuzumab vedotin.
Contacts and Locations
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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 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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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 17, 2022
Last Verified: May 2022
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)
Time Frame: For details on when studies are available for sharing, please refer to the link below.
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://vivli.org/ourmember/abbvie/

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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
MET gene amplification
LUMINOSITY
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