試験ID UMIN000055099
最終情報更新日：2026年1月31日
進行非扁平上皮・非小細胞肺癌に対する免疫チェックポイント阻害剤投与後のnab-パクリタキセル+ベバシズマブ併用療法の有効性や安全性に関する多施設共同の第Ⅱ相試験
基本情報
| 試験ID | UMIN000055099 | |
|---|---|---|
| 研究名称 / Scientific Title（Acronym） | 進行非扁平上皮・非小細胞肺癌に対する免疫チェックポイント阻害剤投与後のnab-パクリタキセル+ベバシズマブ併用療法の有効性や安全性に関する多施設共同の第Ⅱ相試験 | Efficacy and safety of nanoparticle albumin-bound paclitaxel plus bevacizumab after immune checkpoint inhibitor therapy in patients with advanced non-squamous non-small cell lung cancer: a phase II trial |
| 平易な研究名称 / Public Title（Acronym） | Efficacy and safety of nanoparticle albumin-bound paclitaxel plus bevacizumab after immune checkpoint inhibitor therapy in patients with advanced non-squamous non-small cell lung cancer: a phase II trial | |
| 試験進捗状況/Recruitment status | 一般募集中 | Recruiting |
| 登録日時 | 2024年7月29日 | |
| 最終情報更新日 | 2026年1月31日 | |
| 試験開始日（予定日） | ||
| 試験終了日（予定日） | ||
| 組入れ開始日 / Date of first enrollment | ||
試験概要
| 試験実施地域 / Region | 日本 | Japan |
|---|---|---|
| 実施都道府県 | ||
| 目標症例数/Target sample size | 31 | |
| 対象疾患 / Health condition(s) or Problem(s) studied | 免疫チェックポイント阻害剤併用療法で治療後の進行期非扁平上皮・非小細胞肺癌 | Advenced non-squamous, non-small cell lung cancer immediately after immune checkpoint inhibitors failure |
| 試験のタイプ / Study type | 介入 | Interventional |
| 試験デザイン / Study design | ||
| ランダム化 / Randomization | ||
| 介入1 | 化学療法 | |
| 主要評価項目 / Primary outcomes | 奏効率 | Objective response rate |
| 副次評価項目 / Secondary outcomes | Progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and saftey. Subset analysis of efficacy (ORR, DCR, PFS, and OS) stratified by presense of driver mutations (EGFR, ALK, ROS1, BRAF V600E, KRAS G12C, HER2, METex14skipping, NTRK), smoking history,degree of tumor PD-L1 expression, tumor TTF-1 expression, and tumor response and duration of response of previous treatment. | |
適格性
| 年齢（下限）/ Age minimum | 18歳以上 | 18years-old |
|---|---|---|
| 年齢（上限）/ Age maximum | Not applicable | |
| 性別 / Gender | 男女両方 | Male and Female |
| 選択基準 / Include criteria | ||
| 除外基準 / Exclude criteria | 1) Allergy or hypersensitibity against the medicines in this trial or albumin. 2) Patients who previously treated with paclitaxel or nab-paclitaxel. 3) Peripheral neuropathy (grade 2 or more) before the treatment. 4) Uncontrolable pleural or pericardial effusion, or ascites. 5) Patients undergoing radiotherapy, or within 2 weeks after thoracic or brain radiotherapy completion and within 1 week after radiotherapy for bone metastasis. 6) Operation within 4 weeks. 7) Active double cancer. 8) High body temperature (38 degrees Celsius and more). 9) Severe complications including gastrointestinal bleeding, perforation of the gastrointestinal tract, fistulae, diverticulitis, intestinal paralysis, intestinal obstruction, superior vena cava syndrome, uncontrolled thromboembolism or hypertension, gastrointestinal ulcers, interstitial pneumonia or pulmonary fibrosis evident on chest X-ray, heart failure, hepatic failure, and renal failure. 10) Pregnant and breastfeeding woman. 11) HBs antigen positive. 12) Patients receiving systemic administration of more than 10 mg of prednisolone equivalent of corticosteroids at the time of enrollment. 13) Patients with untreated brain metastases or cerebral hemorrhage on CT or MRI within 2 months prior to enrollment. 14) Patients with hemoptysis (2.5 mL or more of fresh blood) within 2 months prior to enrollment. 15) Patients with major blood vessels tumor invasion or intratumour cavitation, or tumor exposure into the lumen of the central airway above the regional bronchus on CT. 16) The subjects whom the doctor excluded. 17) Patients taking anticoagulants (warfarin, dabigatran, edoxaban, rivaroxaban, apixaban) or antiplatelet agents (aspirin, clopidogrel, prasugrel, ticlopidine, cilostazol). |
責任研究者
| 責任研究者 / Name of lead principal investigator | Yukihiro Umeda | |
|---|---|---|
| 組織名 / Organization | ||
| 部署名 / Division | Faculty of Medical Sciences, University of Fukui Department of Respiratory Medicine | |
| 住所 / Address | 23-3 Matsuoka-Shimoaizuki, Eiheiji, Fukui Japan | |
| 電話 / Telephone | 0776-61-3111 | |
| 実施責任組織 / Affiliation | 福井大学 病態制御医学講座 呼吸器内科学分野 | Faculty of Medical Sciences, University of Fukui Department of Respiratory Medicine |
| 研究費提供組織 / Funding Source | None | |
| 共同実施組織 / Funding Source | ||
| 受付ID |
試験問い合わせ窓口
| 住所 / Address | 23-3 Matsuoka-Shimoaizuki, Eiheiji, Fukui Japan 9101193 | |
|---|---|---|
| 電話 / Telephone | 0776-61-3111 | |
| ホームページURL | ||
| umeda@u-fukui.ac.jp | ||
| 担当者 / Name of contact person | Yukihiro Umeda |