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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 : April 26, 2023
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 April 26, 2023
Actual Study Start Date  ICMJE October 10, 2018
Estimated Primary Completion Date September 24, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2022)
  • Overall Response Rate (ORR) (Stage 1 and Stage 2) [ 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.
  • Number of Participants with Adverse Events (Alternate dose cohort) [ Time Frame: Up to approximately 3 years ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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: September 12, 2022)
  • Duration of Response (DoR) (Stage 1 and Stage 2) [ 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) (Stage 1 and Stage 2) [ 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) (Stage 1 and Stage 2) [ 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) (Stage 1 and Stage 2) [ 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 overexpress 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). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3).
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: March 20, 2023)
275
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2018)
310
Estimated Study Completion Date  ICMJE September 24, 2025
Estimated Primary Completion Date September 24, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have locally advanced or metastatic non-small cell lung cancer (NSCLC).
  • Have 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 prescreening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. If archival tissue is negative for c-Met overexpression, subject can submit fresh biopsy material for reassessment of c-Met expression.
  • Histologically documented non-squamous epidermal growth factor receptor (EGFR) wild type NSCLC (site documented EGFR status). Of note, subjects with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met. As of Protocol Version 11, Stage 1 is complete and Stage 2 is enrolling participants with non-squamous EGFR wild type NSCLC only.
  • Must 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 tyrosine kinase (TK) count as 1 line of therapy for the purposes of this eligibility criterion.
  • Progressed on systemic cytotoxic therapy (or are ineligible for systemic cytotoxic chemotherapy) and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible), and prior anticancer therapies targeting driver gene alterations (if applicable).
  • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • Treatment with any therapies within the noted time intervals is excluded prior to the first dose of telisotuzumab vedotin as noted in the protocol.
  • Metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided within the protocol.

Exclusion Criteria:

  • Have received radiation therapy to the lungs < 6 months prior to the first dose of telisotuzumab vedotin.
  • Have received any live vaccine within 30 days of the first dose of investigational product.
  • Has adenosquamous histology.
  • Have a history of other malignancies except those noted within the protocol.
  • Have a history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids.
  • Have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD within 3 months of the planned first dose of the study drug (Except for Sites in Ireland). For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.
  • For Sites in Ireland Only: Must not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD. For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.
  • Have a clinically significant condition(s) as noted in the protocol.
  • Have unresolved clinically significant adverse events of Grade >= 2 from prior anticancer therapy, except for alopecia or anemia.
  • Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
  • For Sites in France and Czech Republic Only: Have the following:

    • Known human immunodeficiency virus (HIV) infection. Note: HIV testing is not required for eligibility for this protocol unless mandated by local regulatory authority or ethics committee/institutional review board.
    • Active hepatitis B virus (HBV) infection, defined by hepatitis B surface antigen (HBsAg) positivity or HBV DNA >= 500 IU/mL. In participants with known HBV infection, the presence of active infection must be tested locally. If HBV status is unknown, it must be tested locally at screening.
    • Active hepatitis C virus (HCV) infection, defined by HCV ribonucleic acid (RNA) positivity. Participants cured of HCV infection may be included in the study. In participants with known HCV infection, the presence of active infection must be tested locally. If HCV status is unknown, it must be tested locally at screening.
    • Uncontrolled autoimmune disease.
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, analyses plans, 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: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/
Current Responsible Party AbbVie
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AbbVie
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ABBVIE INC. AbbVie
PRS Account AbbVie
Verification Date April 2023

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