ALK陽性非小細胞肺癌患者における術後補助化学療法としてのアレクチニブとプラチナ製剤併用化学療法の比較研究

基本情報

NCT ID

NCT03456076

ステータス

実施中（募集終了）

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

257

治験依頼者名

Hoffmann-La Roche

概要

This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.

対象疾患

介入

依頼者（Sponsor）

実施施設 (17)