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| Overall Recruitment Status: Active, currently enrolling |
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| 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
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| Region |
Sponsors |
| Hawaii |
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| Acronym |
KP IRB No. |
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13140 |
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| Study Type |
Phase |
| Clinical Trial |
Phase III |
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| Study Population Description |
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| Purpose |
| 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. |
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| Detailed Description |
| 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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| Gender |
Age Limit |
| Male & Female |
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- c-Met overexpressing NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory.
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.
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.
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: 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.
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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