Active, not yet recruiting
A Phase 2, Open-Label, Randomized, Global Study of Two Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
NCT No.: NCT06568939
Study Type: INTERVENTIONAL
Phase:
Phase II
Official Title
A Phase 2, Open-Label, Randomized, Global Study of Two Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Purpose
The purpose of this study is to see if the study drug telisotuzumab vedotin at the 1.6mg/kg and 1.9mg/kg dose levels is safe and effective in treating subjects with previously treated c-Met overexpressing, epidermal growth factor receptor (EGFR) wildtype, locally advanced / metastatic non-squamous non-small cell lung cancer.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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Inclusion Criteria:
-Projected life expectancy of at least 12 weeks.
-Must have histologically or cytologically documented nonsquamous cell Non-small cell lung cancer (NSCLC) that is locally advanced or metastatic.
-Must have a known epidermal growth factor receptor (EGFR) activating mutation status.
-Actionable alterations in genes other than EGFR are permitted.
-Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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Exclusion Criteria
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Exclusion Criteria:
-Adenosquamous or neuroendocrine histology, or sarcomatoid features.
-Actionable EGFR activating mutations.
-Received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drugconjugates either targeting c-Met or consisting of monomethylauristatin E.
-Received prior docetaxel therapy.
-Metastases to the central nervous system (CNS) are eligible only after adequate treatment (such as surgery or, radiotherapy, or drug therapy) is provided, as stated on the protocol.
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Keywords and/or Specific Medical Conditions
Sponsors
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