A National, Multi Center, Randomized, Open-label, Phase III Trial of Gefitinib Versus Combination of Vinorelbine Plus Platinum as Adjuvant Treatment in Pathological Stage II-IIIA(N1-N2) Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutation
Adjuvant cisplatin-based chemotherapy is recommended for routine use in patients with stages
IIA, IIB, and IIIA non-small cell lung cancer (NSCLC) after complete resection. Cisplatin
and vinorelbine combination is the standard of care in adjuvant setting. The BR. 19 trial
reported adjuvant gefitinib after complete resection of early stage NSCLC(stage IB 49%, II
38%, III 13%) did not confer disease free survival(DFS) or overall survival(OS) advantage in
overall population. While the median gefitinib treatment time is only 4.8 months. There are
only 76 patients with EGFR mutations included in this analysis. The study closed prematurely
Activating somatic mutations of the tyrosine kinase domain of epidermal growth factor
receptor (EGFR) have been characterized in a subset of patients with advanced NSCLC.The EGFR
mutation rate was 30% in Chinese NSCLC. Patients harboring these mutations in their tumors
show excellent response to EGFR tyrosine kinase inhibitors (EGFR-TKIs). This randomized
phase III trial is studying gefitinib to see how well it works compared to cisplatin-based
chemotherapy in treating patients who have undergone surgery for stage II-IIIA(N1-N2) NSCLC
with EGFR activating mutation in Asian population.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free survival
To evaluate the disease free survival of gefitinib versus combination of vinorelbine plus platinum as adjuvant treatment for pathological stage II-IIIA(N1-N2) NSCLC with EGFR mutation.Disease free survival (DFS)- defined as the time from randomization to the first documented disease progression or death, whichever occurs first.
Pts after surgery will receive long-term follow-up including chest CT scan, abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan every 12 months for up to 3 years. The survival after 3 years will be followed up with telephone.
Yi-Long WU, MD
Guangdong General Hospital
China: Food and Drug Administration