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A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT05513703
Recruitment Status : Recruiting
First Posted : August 24, 2022
Last Update Posted : January 18, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed.

Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide.

Participants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Biological: Telisotuzumab Vedotin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Actual Study Start Date : November 21, 2022
Estimated Primary Completion Date : November 15, 2025
Estimated Study Completion Date : November 15, 2026

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
Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
 Biological: Telisotuzumab Vedotin
Intravenous (IV) Infusion
Other Name: ABBV-399


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (ORR) as Assessed by an Independent Central Review (ICR) [ Time Frame: Up to 1 Year ]
    ORR will be 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 1 Year ]
    DoR will be defined for confirmed responders as the time from the initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1, or death from any cause.

  2. Disease Control Rate (DCR) [ Time Frame: Up to 1 Year ]
    DCR will be defined as the percentage of participants with best overall response of confirmed CR or confirmed PR, or stable disease (SD) for at least 12 weeks following first dose of study drug, based on RECIST, version 1.1.

  3. Progression Free Survival (PFS) per ICR [ Time Frame: Up to 1 Year ]
    PFS will be defined as the time from the participant's first dose of study drug to the first occurrence of radiographic progression based on RECIST, version 1.1 or death from any cause.

  4. Overall Survival (OS) [ Time Frame: Up to 2 Years ]
    OS will be defined as the time from participant's first dose of study drug to the event of death from any cause.

  5. Time to Deterioration in Cough [ Time Frame: Up to 1 Year ]
    Time to deterioration in cough as measured by the cough items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13).

  6. Time to Deterioration in Pain [ Time Frame: Up to 1 Year ]
    Time to deterioration in pain as measured by the cough items of the EORTC QLQ-LC13.

  7. Time to Deterioration in Dyspnea [ Time Frame: Up to 1 Year ]
    Time to deterioration in dyspnea as measured by the cough items of the EORTC QLQ-LC13.

  8. Time to Deterioration of Physical Functioning [ Time Frame: Up to 1 Year ]
    Time to deterioration of physical functioning as measured by the physical functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30).

  9. Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). [ Time Frame: Up to 1 Year ]
    The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.


Eligibility Criteria
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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:

  • Must have MET amplification in tumor tissue as determined by the Sponsor-designated central laboratory or in plasma and/or tissue by a Sponsor-approved assay.
  • Must have histologically documented non-squamous cell non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.
  • Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Participant may have received prior adjuvant/neoadjuvant systemic chemotherapy and/or radiation if it was completed >= 6 months before participant's first dose of study drug.
  • Metastases to the central nervous system (CNS) are eligible only after definitive therapy is provided as noted in the protocol.
  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.

Exclusion Criteria:

  • Have adenosquamous histology.
  • Alterations in EGFR, ALK, ROS1, or BRAF that predict sensitivity to targeted therapy. Participants with other alterations that are candidates for available targeted therapy.
  • Prior systemic therapy for locally advanced/metastatic NSCLC.
  • Have a history of other malignancies except those noted in the protocol.
  • Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
  • Received prior c-Met-targeted antibodies.
  • Have NSCLC that is eligible for treatment with curative intent.
  • Have unresolved clinically significant adverse events (AEs) >= 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.
  • Have clinically significant condition(s) as noted in the protocol.
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): NCT05513703


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: NCT05513703    
Other Study ID Numbers: M22-137
2022-500608-23-00 ( Other Identifier: EU CT )
First Posted: August 24, 2022    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023
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, 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
Statistical Analysis Plan (SAP)
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/

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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.: Yes
Keywords provided by AbbVie:
c-Met NSCLC
Telisotuzumab Vedotin
ABBV-399
Cancer
 Non Small Cell Lung Cancer
NSCLC
MET Amplified NSCLC
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