NCT04928846
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.
Interventional study
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Please note, participation in the clinical trial is open to patients with the disease or condition under investigation. |
Age:
18 Years and older.
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.
