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)

  • STATUS
    Recruiting
  • End date
    Mar 21, 2028
  • participants needed
    698
  • sponsor
    AbbVie
Updated on 13 June 2022
measurable disease
growth factor
epidermal growth factor receptor
EGFR
docetaxel
c-MET
cancer chemotherapy
epidermal growth factor
platinum-based chemotherapy
lung carcinoma
squamous non-small cell lung cancer
non-squamous non-small cell lung cancer

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 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.

Details
Condition Non Small Cell Lung Cancer
Treatment docetaxel, Telisotuzumab vedotin
Clinical Study IdentifierNCT04928846
SponsorAbbVie
Last Modified on13 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must have c-Met overexpressing 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. Tumor material from the primary tumor site and/or metastatic sites are allowed
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
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 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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