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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 : Recruiting
First Posted : June 16, 2021
Last Update Posted : May 2, 2024
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 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. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing 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 ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 698 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 Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Actual Study Start Date : March 25, 2022
Estimated Primary Completion Date : June 7, 2025
Estimated Study Completion Date : March 21, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

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


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival (PFS) per Independent Central Review (ICR) [ 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 ICR or death from any cause.

  2. Overall Survival (OS) [ Time Frame: Up to approximately 39 months ]
    OS is defined as the time from randomization to the event of death from any cause.


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

  2. Duration of Response (DoR), per ICR [ 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.

  3. PFS per Investigator Assessment [ Time Frame: Up to approximately 58.25 months ]
    PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 per investigator or death from any cause. Participants with no PFS event will be censored at the last evaluable radiographic assessment per investigator. Participants with no event and no evaluable post-baseline assessment will be censored at randomization.

  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.


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:

  • Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay.

  • Archival or fresh tumor material must be submitted for assessment of c-Met levels during the Pre-Screening period. Tumor material from the primary tumor site and/or metastatic sites are allowed.

    • If a participant was prescreened for Study M14-239 but did not enroll, tumor material previously submitted for Study M14-239 may be used for Study M18-868 Pre-Screening upon confirmation from AbbVie that sufficient evaluable tumor material is available (Except China).
  • 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 WITHOUT an actionable gene alteration: must have progressed on (or be considered ineligible for) platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).

    • Participants WITH an actionable gene alteration for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma kinase [ALK] translocation): must have progressed on (or be considered ineligible for) anti-cancer therapy targeting driver gene alterations and platinum-based chemotherapy.

      • Participants with actionable gene alterations for which immune checkpoint inhibitor is standard of care must have also progressed on (or be considered ineligible for) immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
  • Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.

  • 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 2 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, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E..
  • Participants who have received prior docetaxel therapy.

  • 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 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.
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): NCT04928846


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: NCT04928846    
Other Study ID Numbers: M18-868
2021-001811-94 ( EudraCT Number )
First Posted: June 16, 2021    Key Record Dates
Last Update Posted: May 2, 2024
Last Verified: April 2024
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 Overexpressing Non-Small Cell Lung Cancer
c-Met NSCLC
Telisotuzumab Vedotin
ABBV-399
Docetaxel
 Cancer
Non Small Cell Lung Cancer
NSCLC
TeliMET NSCLC-01
Teliso-V
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