ステージIIIの非小細胞肺癌（NSCLC）におけるペムブロリズマブと同時化学放射線療法、およびそれに続くペムブロリズマブ単独またはオラパリブ単独の併用療法の試験（MK-7339-012/KEYLYNK-012）

基本情報

NCT ID

NCT04380636

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

870

治験依頼者名

Merck Sharp & Dohme LLC

概要

The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are: 1. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS) 2. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS

対象疾患

介入

依頼者（Sponsor）

実施施設 (12)