Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UNC Lineberger Comprehensive Cancer Center
With
Astellas Pharma Global Development, Inc.
Primary Objectives
\- To estimate progression free survival (PFS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy
Secondary Objectives
* To evaluate local control of sites previously progressive on erlotinib following stereotactic radiosurgery (SRS) followed by erlotinib
* To estimate overall survival (OS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy
* To characterize the toxicity of SRS
* To characterize the toxicity of erlotinib when preceded by SRS
Exploratory Objectives
* To explore if VeriStrat results at initial progression are associated with longer PFS or OS after study treatment
* To explore if VeriStrat results following completion of SRS are associated with longer PFS or OS after re-initiation of erlotinib
* To explore whether "poor" VeriStrat signatures ever turn to "good" signatures with the study therapy, and to explore PFS and OS of patients whose signature changes
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent
18 years of age or older
Histologically or cytologically confirmed stge IV EGFR-mutant NSCLC
History of previous response to EGFR-TKI defined by a RECIST 1.1 criteria
Progressive disease following EGFR-TKI therapy
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate organ and marrow function
Negative urine or serum pregnancy test for female patients
Patients who can have children must agree to adequate contraception
You may not be if
Unresolved chronic toxicities greater than 2, measured by CTCAE v4
Treatment with any FDA approved or experimental cancer treatment following progression on EGFR-TKI
Any history of previous greater than grade 3 toxicity attributable to erlotinib
Pregnant or lactating female
Any previous radiation to sites of planned Stereostatic Radiosurgery
History of another malignancy
Concomitant anticancer therapy, immunotherapy, or radiation therapy (within 4 weeks)
Evidence of severe or uncontrolled systemic diseases
Known hypersensitivity reaction or idiosyncrasy to erlotinib
Psychological, familial, sociological, or geographical conditions
Any other condition in investigator's opinion jeopardize compliance with protocol