局所進行または転移性EGFR遺伝子変異陽性非扁平上皮非小細胞肺癌の成人患者を対象に、静脈内（IV）テリソツズマブ・アディズテカンの有害事象および疾患活動性の変化を標準治療と比較評価する研究

基本情報

NCT ID

NCT07155187

ステータス

募集中

試験のフェーズ

第2/第3相

試験タイプ

介入

目標被験者数

430

治験依頼者名

AbbVie

概要

Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan compared to standard of care (SOC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 430 adult participants with NSCLC will be enrolled in the study in 200 sites around the world. In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 months. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

対象疾患

介入

依頼者（Sponsor）

実施施設 (5)