jRCT2061230111招募中不适用
Phase III Study of DFP-14323 plus Afatinib in Patients with NSCLC Harboring Uncommon EGFR mutations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients with histologically or cytologically confirmed diagnosis of lung adenocarcinoma.
- •Patients with stage III/IV inoperable, inoperable by radical radiotherapy, or recurrent after surgery/chemoradiotherapy.
- •Patients with Uncommon EGFR mutation by genetic testing.
- •Patients with disease evaluable by RECIST ver. 1.1 within 4 weeks prior to enrollment.
- •Patients without prior treatment with chemotherapy, including treatment for other cancer types.
- •Patients with Performance Status (ECOG scale): 0 to 1.
排除标准
- •Patients with T790M or Exon20 insertion mutation positive.
- •Patients with a clinical history of interstitial pneumonia or clinical signs of interstitial pneumonia.
- •Patients with active multiple cancers.
- •Patients with symptomatic brain metastases.
- •Patients receiving continuous systemic steroid treatment.
结局指标
主要结局
-
PFS per BICR, according to RECIST ver.1.1 [Time Frame: Up to 54 months]
次要结局
- type and severity of adverse events and side effects
研究者
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