Gefitinib Versus Vinorelbine/Platinum as Adjuvant Treatment in Stage II-IIIA(N1-N2) NSCLC With EGFR Mutation

• Status: Active, not recruiting
• Trial end date: 2020-12-01

Summary

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 Non-small Cell Lung Cancer(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.

• Phase: Phase 3

Details

• Lead Sponsor: Guangdong Association of Clinical Trials
• Collaborators: 309th Hospital of Chinese People's Liberation Army; Beijing Cancer Hospital; Beijing Chest Hospital; China Medical University, China; Chinese PLA General Hospital; First Affiliated Hospital, Sun Yat-Sen University; First Hospital of China Medical University; Fudan University; Guangdong General Hospital; Guangdong Provincial People's Hospital; Jiangsu Cancer Institute & Hospital; Jilin Provincial Tumor Hospital; Liaoning Tumor Hospital & Institute; Peking Union Medical College Hospital; Peking University First Hospital; Peking University People's Hospital; Qingdao University; Shanghai Pulmonary Hospital, Shanghai, China; Sun Yat-sen University; Tang-Du Hospital; The Affiliated Hospital of Qingdao University; The First Affiliated Hospital of Soochow University; Tianjin Medical University Cancer Institute and Hospital; Tongji Hospital; West China Hospital; Wuhan Union Hospital, China; Zhejiang Cancer Hospital; Zhejiang University
• Treatments: Cisplatin; Gefitinib; Vinblastine; Vinorelbine