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A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT04928846
Recruitment Status : Not yet recruiting
First Posted : June 16, 2021
Last Update Posted : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

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 if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed.

Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 600 adult participants with c-Met+ NSCLC will be enrolled in the study in approximately 250 sites worldwide.

Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 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 Drug: Docetaxel Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met+, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Estimated Study Start Date : December 10, 2021
Estimated Primary Completion Date : March 9, 2027
Estimated Study Completion Date : March 9, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

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

Active Comparator: Docetaxel
Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.
Drug: Docetaxel
IV Infusion




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 39 months ]
    PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per Independent Central Review (ICR) or death from any cause.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 58.25 months ]
    OS is defined as the time from randomization to the event of death from any cause.

  2. Objective Response Rate (ORR) [ Time Frame: Up to approximately 58.25 months ]
    ORR is defined as the percentage of subjects with a complete response (CR) or partial response (PR) based on RECIST v1.1, per ICR.

  3. Duration of Response (DoR) [ Time Frame: Up to approximately 58.25 months ]
    DoR is defined for responders as the time from response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause per ICR.

  4. Time to Deterioration in Cough, Pain or Dyspnea as measured by the Cough, Pain and Dyspnea items of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) [ Time Frame: Up to approximately 58.25 months ]
    The EORTC QLQ-LC13 is the lung cancer specific module of the core EORTC QLQ-C30. The QLQ-LC13 includes 13 questions that include both multi-item and single-item scales of lung cancer-associated symptoms (e.g., pain, coughing, hemoptysis, and dyspnea) and side-effects from chemo- and radiotherapy (e.g., hair loss, neuropathy, sore mouth and dysphagia). All scale and item scores are linearly transformed to a 0 to 100 scale, with higher scores representing increasing symptom levels or impacts.

  5. Time to Deterioration of Physical Functioning as measured by the Physical Functioning domain of the EORTC-QLQ-Core 30 (EORTC QLQ-C30). [ Time Frame: Up to approximately 58.25 months ]
    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.

  6. Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30. [ Time Frame: Up to approximately 58.25 months ]
    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.



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.


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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:

  • Participants must have c-Met overexpression (c-Met+) non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory.
  • Archival or fresh tumor material must be submitted for assessment of c-Met levels during the Pre-Screening period.
  • A histologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
  • A known epidermal growth factor receptor (EGFR) activating mutation status.
  • Actionable alterations in genes other than EGFR .
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.

    • Neoadjuvant and adjuvant systemic cytotoxic chemotherapy will count as a prior line for eligibility purposes if progression occurred within 6 months of the end of therapy.
  • Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC:

    • Participants WITH an actionable gene alteration (e.g., anaplastic lymphoma kinase [ALK] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and systemic cytotoxic chemotherapy.
    • Participants WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) systemic cytotoxic chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
  • Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and:

    • There is no evidence of progression of CNS metastases at least 4 weeks after definitive therapy.
    • They are asymptomatic and off or on a stable or reducing dose of systemic steroids and/or anticonvulsants for at least 2 weeks prior to first dose of telisotuzumab vedotin.

Exclusion Criteria:

  • Participants with adenosquamous histology.
  • Actionable epidermal growth factor receptor (EGFR) activating mutations.
  • Participants who have received prior c-Met-targeted antibodies.
  • A history of other malignancies except:

    • Malignancy treated with curative intent and with no known active disease present for ≥2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator.
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    • Adequately treated carcinoma in situ without current evidence of disease.
  • 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. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Unresolved clinically significant adverse event (AE) >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
  • Major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
  • Clinically significant condition(s) as listed in the protocol.

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): NCT04928846


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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United States, Michigan
Ascension Providence Hospital /ID# 231970
Southfield, Michigan, United States, 48075-4825
Slovakia
FNsP F.D.Roosevelta Banska Bystrica /ID# 230084
Banska Bystrica, Banskobystricky Kraj, Slovakia, 975 17
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 230086
Nove Zamky, Nitriansky Kraj, Slovakia, 940 34
Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 232216
Bratislava, Slovakia, 821 01
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04928846    
Other Study ID Numbers: M18-868
2021-001811-94 ( EudraCT Number )
First Posted: June 16, 2021    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: June 2021
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: 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

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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 Overexpression Non-Small Cell Lung Cancer
c-Met+ NSCLC
Telisotuzumab Vedotin
ABBV-399
Docetaxel
Cancer
Non Small Cell Lung Cancer
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
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action