既治療のプログラム細胞死リガンド1(PD-L1)陽性非小細胞肺がん(NSCLC)の成人患者を対象に、PF-08046054/SGN-PDL1Vと呼ばれる試験薬とドセタキセルを比較する試験について学ぶ研究
基本情報
- NCT ID
- NCT07144280
- ステータス
- 募集中
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 680
- 治験依頼者名
- Pfizer
概要
The purpose of this study is to understand if PF-08046054 alone works well compared to standard-of-care docetaxel alone in participants with non-small cell lung cancer (NSCLC) with PD-L1 expression greater than or equal to 1% and had cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted treatment regimen(s) for participants with known actionable genomic alterations (AGAs). Participants in this study must have cancer that has spread through their body or can't be removed with surgery or treated with definitive radiation. Participants will randomly (like a flip of the coin) be assigned to either the PF-08046054 treatment group or the docetaxel treatment group. Participants in the PF-08046054 treatment group will receive an IV infusion (injected directly into the veins) twice during each 21-day cycle. Participants in the docetaxel treatment group will receive an IV infusion once during each 21-day cycle. Study participation may be up to 5 years if the participant's NSCLC is responding to treatment. The study team will see how each participant is doing with the study treatment during regular visits at the clinic.
対象疾患
介入
依頼者(Sponsor)
実施施設 (14)
NHO Kinki Chuo Chest Medical Center
Sakai, Osaka, Japan(NOT_YET_RECRUITING)
独立行政法人国立病院機構長崎医療センター
Ōmura, Nagasaki, Japan(NOT_YET_RECRUITING)
独立行政法人 国立病院機構東京病院
Kiyose, Tokyo, Japan(NOT_YET_RECRUITING)
独立行政法人国立病院機構 九州がんセンター
Fukuoka, Japan(NOT_YET_RECRUITING)
独立行政法人国立病院機構京都医療センター
Kyoto, Japan(NOT_YET_RECRUITING)
独立行政法人国立病院機構 三重中央医療センター
Tsu, Mie-ken, Japan(RECRUITING)
仙台厚生病院
Sendai, Miyagi, Japan(RECRUITING)
独立行政法人国立病院機構高知病院
Kochi, Kochi, Japan(NOT_YET_RECRUITING)
National Hospital Organization Beppu Medical Center
Beppu-shi, Oita Prefecture, Japan(NOT_YET_RECRUITING)
独立行政法人国立病院機構岡山医療センター
Okayama, Japan(RECRUITING)
兵庫県立がんセンター
Akashi, Hyōgo, Japan(NOT_YET_RECRUITING)
日本医科大学付属病院
Bunkyo-ku, Tokyo, Japan(NOT_YET_RECRUITING)
独立行政法人国立病院機構 呉医療センター
Kure, Hiroshima, Japan(NOT_YET_RECRUITING)
大阪大学医学部附属病院
Suita, Osaka, Japan(NOT_YET_RECRUITING)