Jonsson Comprehensive Cancer Center
This phase II trial tests how well telisotuzumab vedotin and osimertinib works for the treatment of non small cell lung cancer that is growing, spreading, or getting worse (progressive) and for which no treatment is currently available (incurable). Telisotuzumab vedotin is a monoclonal antibody, called telisotuzumab, linked to a toxic agent, called vedotin. Telisotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as c-Met receptors, and delivers vedotin to kill them. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving telisotuzumab vedotin and osimertinib may be effective for treating progressive, incurable non small cell lung cancer.
PRIMARY OBJECTIVES: I. Objective response rate (ORR) as defined as complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. II. Progression free survival (PFS) as defined by time from treatment initiation to disease progression per RECIST 1.1 criteria or death. SECONDARY OBJECTIVES: I. Duration of response (DOR), time to response (TTR) and overall survival (OS). II. Assess the safety and tolerability of induction and maintenance schedule of telisotuzumab vedotin when given with osimertinib in all evaluable patients who receive…
Inclusion Criteria: * Male or female ≥ 18 years of age and willing and able to provide informed consent * Cytologically or histologically confirmed non small cell lung cancer (NSCLC), which is incurable with an activating and sensitizing EGFR mutation (e.g., exon 20 insertion mutations are excluded). Enrollment of patients with mutations other than exon 19 deletion and the L858R point mutation require literature supporting sensitivity to osimertinib. T790M mutations and identified EGFR mutations that are known to confer resistance to osimertinib (for instance C797S) are allowed * Predominantl…
Undergo tumor biopsy
Undergo blood sample collection
Undergo CT scan
Undergo MRI
Given PO
Ancillary studies
Given IV
Arctuva estimate
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