EGFR活性化変異を有するステージIIIB/IV非小細胞肺癌患者の一次治療におけるASP8273とエルロチニブまたはゲフィチニブの比較研究

基本情報

NCT ID: NCT02588261
ステータス: 中止
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 530
治験依頼者名: Astellas Pharma Inc

概要

The purpose of the study was to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. This study also assessed Overall survival (OS); Overall response rate (ORR) as assessed by IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR; Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and patient-reported outcome (PRO) parameters.

対象疾患

Non-small Cell Lung Cancer (NSCLC)

介入

naquotinib mesilate(DRUG)

Erlotinib(DRUG)

Gefitinib(DRUG)

依頼者（Sponsor）

アステラス製薬株式会社(INDUSTRY)