既治療の非扁平上皮非小細胞肺癌（NSCLC）の成人患者を対象に、単剤療法として静脈内（IV）投与されたテリソツズマブ ベドチン（ABBV-399）の有害事象および体内での動態を評価する研究

基本情報

NCT ID

NCT06568939

ステータス

募集中

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

150

治験依頼者名

AbbVie

概要

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 70 to 80 sites worldwide. Participants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

対象疾患

介入

依頼者（Sponsor）

実施施設 (11)