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進行性/転移性非扁平上皮非小細胞肺癌(NSCLC)の成人患者におけるテリソツズマブベドチンの静脈内(IV)注入による疾患活動性を評価する研究

基本情報

NCT ID
NCT05513703
ステータス
中止
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
9
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 determine how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria. 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

Non Small Cell Lung Cancer

介入

Telisotuzumab Vedotin(BIOLOGICAL)

依頼者(Sponsor)

実施施設 (8)

National Cancer Center Hospital /ID# 250319

Chuo-ku, Tokyo, Japan

独立行政法人国立病院機構 九州がんセンター

Fukuoka, Fukuoka, Japan

地方独立行政法人 大阪府立病院機構 大阪国際がんセンター

Osaka, Osaka, Japan

医療法人社団イースト会 新宿東口イースト駅前クリニック

Kashiwa-shi, Chiba, Japan

国立研究開発法人国立がん研究センター中央病院

Kashiwa-shi, Chiba, Japan

地方独立行政法人 静岡市立静岡病院

Sunto-gun, Shizuoka, Japan

北海道大学病院

Sapporo, Hokkaido, Japan

静岡県立静岡がんセンター

Sunto-gun, Shizuoka, Japan