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既治療の非小細胞肺癌におけるSGN-B6Aとドセタキセルの比較研究

基本情報

NCT ID
NCT06012435
ステータス
実施中(募集終了)
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
703
治験依頼者名
Seagen Inc.

概要

This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable genomic alterations must have had at least 1 drug for that genomic alteration, in addition to platinum-based chemotherapy. This clinical trial uses an experimental drug called sigvotatug vedotin, which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has been approved to treat non-small cell lung cancer. It is usually given to patients who previously received another anticancer treatment. In this study, one group of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A second group of participants will get docetaxel on Day 1 during each 21-day cycle. This study is being done to see if sigvotatug vedotin works better than docetaxel to treat participants with NSCLC. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

対象疾患

Carcinoma, Non-Small-Cell Lung

介入

sigvotatug vedotin(DRUG)
docetaxel(DRUG)

依頼者(Sponsor)

実施施設 (16)

群馬県立がんセンター

Ota-Shi, Gunma, Japan

大阪医科薬科大学病院

Takatsuki-shi, Osaka, Japan

公益財団法人がん研究会 有明病院

Koto-ku, Tokyo, Japan

独立行政法人国立病院機構四国がんセンター

Matsuyama, Ehime, Japan

久留米大学病院

Kurume, Fukuoka, Japan

新潟県立がんセンター新潟病院

Niigata, Niigata, Japan

愛知県がんセンター

Nagoya, Aichi-ken, Japan

近畿大学病院

Sakai, Osaka, 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, Other, Japan

独立行政法人労働者健康安全機構 神戸労災病院

Kobe, Hyōgo, Japan

地方独立行政法人東京都立病院機構 東京都立駒込病院

Bunkyo-ku, Tokyo, Japan

神奈川県立がんセンター

Yokohama, Kanagawa, Japan

国立大学法人金沢大学附属病院

Kanazawa, Ishikawa-ken, 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

日本医科大学付属病院

Bunkyo-ku, Tokyo, Japan

静岡県立静岡がんセンター

Sunto-gun, Shizuoka, Japan