JPRN-jRCTs031180331已完成2 期
A phaseII/III study comparing nivolumab (NIV) with nivolumab (NIV) plus docetaxel (DTX) in patients with previously treated advanced non-small-cell lung cancer: a randomized phase II/III trial(CONDUCT study) - TORG1630
Okamoto Hiroaki0 个研究点目标入组 131 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 131
研究概览
简要总结
The combination of nivolumab and docetaxel was associated with increased adverse events compared to nivolumab alone. However, the combination of nivolumab and docetaxel was considered to be a significantly better and more promising treatment than nivolumab monotherapy, as the primary endpoint was met and study treatment B was significantly better than standard treatment A in the secondary efficacy endpoint.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Histologically or cytologically confirmed NSCLC.
- •2.Previously treated, at least one regimen cytotoxic chemotherapy, and stage III or IV or post operation recurrence.
- •3.Less than 2 regimen previous chemotherapy. EGFR-TKI and ALK-TKI are not regarded as regimen.
- •4.Aged 20 years or older.
- •5.ECOG performance status 0 to 1.
- •6.Written informed consent.
排除标准
- •1.Previously treated by docetaxel.
- •2.Previously treated by antibody targeting to PD-1, PD-L1, PD-L2, CD137, or CTLA-4.
- •3.Synchronous or metachronous (within 5 years) malignancies, except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
- •4.Active CNS metastasis or meningitis carcinomatous. (If patients were received brain radiation, and stable clinically, it is eligible.)
- •5.Evident interstitial pneumonia in CT.
研究者
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