Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)

• Status: Completed
• Trial end date: 2019-03-15
• Target enrollment: 0
• Participant gender: All

Summary

• Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: Astellas Pharma Global Development, Inc.
• Treatments: Erlotinib Hydrochloride; Mitogens

Criteria

Inclusion Criteria:

• 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

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