NCT01312337Unknown2 期
A Phase II Trial of Gefitinib Monotherapy in Pretreated Patients With Advanced Non-small Cell Lung Cancer Not Harboring Active EGFR Mutations
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- To determine disease control rate at 8 weeks will be 35% or higher in the the study group
研究概览
简要总结
The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven NSCLC
- •Ineligibile for curative treatment (namely, stage IIIb or IV)
- •History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21)
- •At least one lesion that was unidimensionally measurable by computed tomography (by RECIST 1.1)
- •18 years old or older
- •Performance status ECOG 0-2
- •Adequate organ function as evidenced by the following:
- •Absolute neutrophil count > 1.0 x 109/L
- •Platelets > 75 x 109/L
- •Total bilirubin ≤ 1.5 UNL
- •AST and/or ALT < 5 UNL
- •Creatinine clearance ≥ 45mL/min
排除标准
- •Previous EGFR TKI therapy history
- •Systemic anticancer therapy within the previous 3 weeks
- •Other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer
- •Other concurrent illness that would preclude study participation (severe heart disease)
- •Other concurrent physical condition (e.g., infectious disease) that would preclude study participation
- •Pregnant or nursing
研究组 & 干预措施
Iressa for EGFR wild group
Experimental
salvage Iressa therapy for patients with EGFR mutation negative NSCLC patients
干预措施: salvage iressa (Drug)
结局指标
主要结局
To determine disease control rate at 8 weeks will be 35% or higher in the the study group
时间窗: 6 months after the enrollment of the last patients
次要结局
- The number of patients who live longer than 6 months after enrollment(6 months after the enrollment of the last patients)
研究者
研究点 (1)
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