Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 29
- 主要终点
- Disease-Control Rate
研究概览
简要总结
Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-squamous stage III non-small cell lung cancer
- •measurable disease (RECIST 1.1)
- •ECOG performance status 0-1
- •normal organ and marrow function
排除标准
- •prior chest radiation therapy
- •history of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years.
- •Prior therapy with known specific inhibitors of the EGFR.
- •history of severe allergic reaction to prior therapy with monoclonal antibodies
研究组 & 干预措施
A
Chemoradiotherapy
干预措施: Chemotherapy (Drug)
A
Chemoradiotherapy
干预措施: ERBITUX (Drug)
A
Chemoradiotherapy
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Disease-Control Rate
时间窗: 16 weeks after inclusion
percentage of patients with disease control (complete response + partial response + stable disease) according to RECIST 1.1 criteria Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease (at least a 20% increase in the sum of diameters of target lesions).
次要结局
- 18-month Overall Survival Rate(18 months)
- Progression Free Survival(52.3 months (median duration of follow-up))