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Trial record 1 of 1 for:    NCT03539536
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Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03539536
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE May 17, 2018
First Posted Date  ICMJE May 29, 2018
Last Update Posted Date September 14, 2021
Actual Study Start Date  ICMJE October 10, 2018
Estimated Primary Completion Date January 16, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE Drug: Telisotuzumab vedotin
Intravenous (IV) infusion
Other Name: ABBV-399
Study Arms  ICMJE Experimental: Telisotuzumab vedotin
Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.
Intervention: Drug: Telisotuzumab vedotin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2021)
233
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2018)
310
Estimated Study Completion Date  ICMJE January 16, 2025
Estimated Primary Completion Date January 16, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Australia,   Belgium,   Bulgaria,   Canada,   China,   Czechia,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Spain,   Switzerland,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03539536
Other Study ID Numbers  ICMJE M14-239
2018-001772-38 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ABBVIE INC. AbbVie
PRS Account AbbVie
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP