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
The purpose of this study is to determine if telisotuzumab vedotin therapy is superior to docetaxel in subjects with c-Met overexpressing epidermal growth factor receptor (EGFR) wildtype, non-squamous, Non-Small Cell Lung Cancer (NSCLC) that has progressed after standard of care therapies.
The study is designed to determine if telisotuzumab vedotin therapy is superior to docetaxel in subjects with c-Met overexpressing, EGFR wildtype, non-squamous NSCLC that has progressed after standard of
care therapies.
The objectives of the study are to determine if telisotuzumab vedotin improves progression-free survival and/or overall survival compared to docetaxel in the following nested populations:
? Subjects with c-Met high overexpressing, EGFR wildtype, non-squamous NSCLC
and
? All subjects with c-Met overexpressing, EGFR wildtype, non-squamous NSCLC.
The clinical hypothesis is that telisotuzumab vedotin is superior to docetaxel for PFS and/or OS in subjects with c-Met high, EGFR wildtype, non-squamous NSCLC, and superior to docetaxel for PFS
and/or OS in all subjects with c-Met overexpressing, EGFR wildtype, non-squamous NSCLC.
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c-Met overexpressing NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory.
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Archival or fresh tumor material submitted for assessment of c-Met levels during Pre-Screening. Tumor material from the primary tumor site and/or metastatic sites are allowed.
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A histologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
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A known epidermal growth factor receptor (EGFR) activating mutation status.
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Actionable alterations in genes other than EGFR .
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Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
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Have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
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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.
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Have progressed on at least 1 line of prior therapy for locally advanced/metastatic NSCLC.
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Must be considered appropriate for docetaxel therapy based on the assessment of the treating physician.
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Participants with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided and: no evidence of progression of CNS metastases at least 4 weeks after definitive therapy, 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.
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Participants with adenosquamous histology.
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Actionable epidermal growth factor receptor (EGFR) activating mutations.
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Participants who have received prior c-Met-targeted antibodies.
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Participants who have received prior docetaxel therapy.
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A history of other malignancies except:
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Malignancy treated with curative intent and with no known active disease present for >=2 years before the
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first dose of study drug and felt to be at low risk for recurrence by investigator.
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Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
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Adequately treated carcinoma in situ without current evidence of disease.
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A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced
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pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed
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tomography (CT) scan. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
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Unresolved clinically significant adverse event (AE) >= Grade 2 from prior anticancer therapy, except for
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alopecia or anemia.
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Major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
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Clinically significant condition(s) as listed in the protocol.
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