The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients.
The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients. The purpose is to explore the role of TKI in neoadjuvant therapy, and to further improve disease-free survival (DFS) and pathologic complete remission (pCR) in EGFR-mutant populations; and reduce surgical complications and mortality. OBJECTIVES: To evaluate the efficacy of oral gefitinib versus neoadjuvant vinorelbine and carboplatin in operable stage II-IIIA EGFR-mutant non-squamous NSCLC patients, with a 2-year disease-free survival rate. 2yDFS). Secondary objective: To evaluate pCR, 0RR, and other efficacy measures (safety, complete) for oral gefitinib vs. neoadjuvant vinorelbine and carboplatin in patients with operable stage II-IIIA EGFR-mutant non-squamous cell carcinoma NSCLC. Resection rate, tumor regression, mediastinal lymph node clearance, perioperative complications, and mortality rate).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Gefitinib (250 mg, orally, every day) for 56 days
Vinorelbine (60 mg/m2, orally, Once every three weeks) for 6 weeks
Carboplatin (AUC5, intravenously drip, once a week) for 6 weeks
Shenzhen People's Hospital
Shenzhen, Guangdong, China
RECRUITING2y DFS
2-year disease-free survival
Time frame: 2 years
ORR
objective response rates
Time frame: 6 months
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