肺癌患者におけるデュルバルマブと化学療法による治療後のデュルバルマブ＋オラパリブまたはデュルバルマブの併用療法に関する研究（ORION）

基本情報

NCT ID: NCT03775486
ステータス: 実施中（募集終了）
試験のフェーズ: 第2相
試験タイプ: 介入
目標被験者数: 401
治験依頼者名: AstraZeneca

概要

This is a randomized, double-blind, multi-center, global Phase II study to determine the efficacy and safety of Durvalumab plus Olaparib combination therapy compared with Durvalumab monotherapy as maintenance therapy in patients whose disease has not progressed following Standard of Care (SoC) platinum-based chemotherapy with Durvalumab as first-line treatment in patients with Stage IV non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

対象疾患

Non-small Cell Lung Cancer NSCLC

介入

Durvalumab(DRUG)

Placebo for Olaparib(DRUG)

Olaparib(DRUG)

Nab-paclitaxel+carboplatin(DRUG)

Gemcitabine+carboplatin(DRUG)

Pemetrexed+carboplatin(DRUG)

Gemcitabine+cisplatin(DRUG)

Pemetrexed+cisplatin(DRUG)

依頼者（Sponsor）

アストラゼネカ株式会社(INDUSTRY)