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Beamion LUNG-1:進行癌(HER2遺伝子変異を有する固形癌)の患者を対象に、ゾンゲルチニブの異なる用量を試験する研究

基本情報

NCT ID
NCT04886804
ステータス
募集中
試験のフェーズ
第1相
試験タイプ
介入
目標被験者数
554
治験依頼者名
Boehringer Ingelheim

概要

The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink. In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day. The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.

対象疾患

腫瘍転移非小細胞肺がん

介入

zongertinib(DRUG)

実施施設 (7)

独立行政法人国立病院機構四国がんセンター

Ehime, Matsuyama, Japan(RECRUITING)

近畿大学病院

Osaka, Sakai, Japan(RECRUITING)

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(RECRUITING)

National Cancer Center Hospital

Tokyo, Chuo-ku, Japan(RECRUITING)

広島大学病院

Hiroshima, Hiroshima, Japan(RECRUITING)

国立研究開発法人国立がん研究センター中央病院

Tokyo, Chuo-ku, Japan(RECRUITING)

浜松医科大学医学部附属病院

Shizuoka, Hamamatsu, Japan(RECRUITING)