CRC 14012: Phase II Study of Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib for Patients with EGFR Mutation Who Have Previously Progressed on an EGFR-TKI
Purpose: This is a single arm Phase II trial evaluating a novel treatment strategy for patients with epidermal growth factor receptor (EGFR)-mutant non small cell lung cancer (NSCLC). The study will investigate whether the combination of local ablation (the removal or destruction of diseased cells or tissue) via stereotactic radiosurgery, followed by Erlotinib is effective in increasing progression free survival (PFS) times.
Cancer () - Lung
Howard (Jack) West, M.D.
Swedish Cancer Institute
- 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