This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1001. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Eligible participants will be given orally gefitinib 250mg daily before surgery for 42 days or until disease progression or unacceptable toxicity. Best supportive care is allowed in this period.
Fudan University Shanghai Cancer Center
Shanghai, China
Objective response rate (ORR)
Time frame: at day 42 of gefitinib treatment
Pathologic response rate
Time frame: Pathologic response rate is depended on the pathology dignosis after surgery, an expected average of 8 weeks from enrollment.
Complete resection rate
Time frame: Complete resection rate is depended on the pathology dignosis after surgery, an expected average of 8 weeks from enrollment.
Number of participants with adverse events
Time frame: During the neoadjuvant and perioperative period, an expected average of 10 weeks from enrollment
Quality of life (QoL)
Time frame: During the neoadjuvant period, an expected average of 6 weeks from enrollment
Disease free survival (DFS)
Time frame: Participants after surgery will receive long-term follow-up for up to 5 years
Overall survival (OS)
Time frame: Participants after surgery will receive long-term follow-up for up to 5 years
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