未治療の進行期小細胞肺癌（ES期）患者を対象とした、カルボプラチンとエトポシド併用療法（アテゾリズマブ併用または非併用）に関する研究

基本情報

NCT ID

NCT02763579

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

503

治験依頼者名

Hoffmann-La Roche

概要

This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

対象疾患

介入

依頼者（Sponsor）

実施施設 (13)