Lung Neoplasms Clinical Trial
Official title:
Pemetrexed Disodium and Cisplatin Chemotherapy Combined With Synchronous Gefitinib vs Chemotherapy Alone as Adjuvent Therapy in Patient With Stage II-IIIA, Epidermal Growth Factor Receptor Mutant Expressing Lung Adenocarcinoma
This randomized phase III trial is studying gefitinib and synchronous pemetrexed/cisplatin chenmotherapy to see how well it works compared to pemetrexed/cisplatin chenmotherapy alone in treating patients who have undergone surgery for stage II-IIIA(N1-N2) lung adenocarcinoma with EGFR activating mutation in Asian population.
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 pemetrexed combination is the standard regimen for lung adenocarcinoma 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 in 2005.
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 and synchronous pemetrexed/cisplatin chenmotherapy to
see how well it works compared to pemetrexed/cisplatin chenmotherapy alone in treating
patients who have undergone surgery for stage II-IIIA(N1-N2) lung adenocarcinoma with EGFR
activating mutation in Asian population.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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