Preoperative Gefitinib for EGFR Mutant II-IIIa NSCLC
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This is an open-label, single-arm, phase II interventional clinical trial. The investigators
hypothesize that the application of EGFR-TKI, like gefitinib will be efficient and safe in a
neo-adjuvant setting. 42 resectable stage II-IIIa NSCLC patients with EGFR activating (19/21)
mutations will be eligible to be enrolled. EGFR mutation will be prospectively tested in all
the participants' biopsy samples and confirmed in surgical resected samples. Eligible
patients will be given gefitinib 250mg for 42days followed with surgical resection of tumor.
Efficacy of preoperative gefitinib is based on radiographic (CT response/ORR), pathologic
(pathologic response), surgical (complete resection) evaluations, and safety is based on
adverse effect evaluations.