進行非小細胞肺癌に対するバイオマーカー標的ペムブロリズマブ（MK-3475）併用療法の研究（MK-3475-495/KEYNOTE-495）

基本情報

NCT ID

NCT03516981

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

245

治験依頼者名

Merck Sharp & Dohme LLC

概要

This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile \[GEP\] and tumor mutational burden \[TMB\]) will be randomized to receive pembrolizumab in combination with quavonlimab (MK-1308), favezelimab (MK-4280), or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either quavonlimab, favezelimab, or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with low GEP and high TMB, 3) greater than 20% among participants with high GEP and low TMB, and 4) greater than 45% among participants with high GEP and high TMB.

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)