チロシンキナーゼ阻害剤（TKI）耐性の上皮成長因子受容体（EGFR）変異を有する転移性非扁平上皮非小細胞肺癌（NSCLC）成人患者を対象とした、ペメトレキセド＋プラチナ製剤併用化学療法（ペムブロリズマブ（MK-3475）併用または非併用）の研究（MK-3475-789/KEYNOTE-789）

基本情報

NCT ID

NCT03515837

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

492

治験依頼者名

Merck Sharp & Dohme LLC

概要

The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib \[TAGRISSO®\] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS. Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.

対象疾患

介入

依頼者（Sponsor）

実施施設 (18)