A Phase 2 Study of HKI-272 In Subjects With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 19
- 主要终点
- Objective Response Rate for Neratinib in Patients With Non-small Cell Lung Cancer
研究概览
简要总结
The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Pathologic diagnosis of NSCLC and current stage IIIB (with pleural effusion) or IV, not curable with conventional therapy. For Arm C, less than or equal to 20 pack-years smoking history and current non smoker. A pack year = number of packs of cigarettes smoked per day x years smoked.
- •Progression following at least 12 weeks of treatment with Tarceva or Iressa. (Arms A and B only)
- •ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 (not declining within past 2 weeks).
- •Tumor sample available and adequate for analysis.
- •At least one measurable target lesion.
- •Adequate cardiac, kidney, and liver function
- •Adequate blood counts
排除标准
- •More than 3 prior cytotoxic chemotherapy treatments for relapsed or metastatic disease.
- •Significant cardiac disease or dysfunction.
- •Prior treatment with anthracyclines with cumulative dose of >400 mg/m^
- •Active central nervous system metastases, as indicated by clinical symptoms and/or progressive growth.
- •Use of Tarceva or Iressa within 14 days of treatment day 1 (Arms A and B only).
- •Major surgery, chemotherapy, radiotherapy, investigational drugs, or other cancer therapy within 3 weeks of treatment day
- •Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
- •Inability or unwillingness to swallow HKI-272 capsules.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Prior Tarceva or Iressa w/o EGFR Mutation
HKI-272 administered to patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening
干预措施: HKI-272 (Drug)
Prior Tarceva or Iressa With EGFR Mutation
HKI-272 administered to patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening
干预措施: HKI-272 (Drug)
No Prior EGFR Tyrosine Kinase Inhibitor Treatment
HKI-272 administered to patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)
干预措施: HKI-272 (Drug)
结局指标
主要结局
Objective Response Rate for Neratinib in Patients With Non-small Cell Lung Cancer
时间窗: From first dose date to progression/death or last tumor assessment, up to three years.
Objective response rate as reported by Independent Assessment (radiographic review by independent radiologists) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
次要结局
- Clinical Benefit Rate for Neratinib in Patients With Non-small Cell Lung Cancer(From first dose date to progression/death or last tumor assessment, up to three years.)
- Duration of Response for Neratinib in Patients With Non-small Cell Lung Cancer(From start date of response to first PD, assessed up to three years after the first randomization.)
- Progression Free Survival for Neratinib in Patients With Non-small Cell Lung Cancer(From first dose date to progression/death, assessed up to three years.)