SHS_492244 WESH CUNC 14012

Phase II Study of Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib for Patients With Epidermal Growth Factor Receptor(EGFR) Mutation Who Have Previously Progressed on an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor (EGFR-TKI)

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 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 following completion of SRS are associated with longer PFS or OS after re-initiation of erlotinib. To explore if VeriStat results following completion of SRS are associated with longer PFS or OS after re-initiation of erlotinib. To explore whether 'poor' VeriStat signatures every turn to 'good' signatures with the study therapy, and to explore PFS and OS of patients whose signature changes. To utilize the full NMR peaks from MALDI-TOF to generate hypotheses regarding alternative signatures for evaluation and novel biomarkers.

Inclusion Criteria:
•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

Exclusion Criteria:
•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
Phase II
NCT01573702
Cancer, All Other
Lung
Howard (Jack) West, M.D.
University of North Carolina
Andrew Smith
  • Swedish Medical Center