An Open-Label, Randomized, Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin in Patients Requiring Second-Line Chemotherapy for Small Cell Lung Cancer That is Refractory or Sensitive to First-Line Platinum-Based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 23
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this trial is to compare the effects of TAS-102 with either amrubicin or topotecan (drugs used in Small Cell Lung Cancer) on lung cancer to find out the effects on survival, how much time may pass without disease progression, and the safety of TAS-102.
详细描述
This is a multicenter, open-label, two-arm, randomized Phase 2 study of TAS-102 versus Investigator's choice of therapy in patients requiring second-line chemotherapy for SCLC refractory or sensitive to first-line platinum-based chemotherapy. Investigator's choice of therapy is defined as second-line chemotherapy with IV topotecan (Europe/Japan) or IV amrubicin (Japan). Patients will be stratified by response to first-line platinum-based chemotherapy (sensitive vs refractory). Sensitive patients are defined as patients who did not progress within 90 days after the last dose, and refractory patients are defined as patients who never responded or who responded but had radiologic progression < 90 days after the last dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Has provided written informed consent
- •Is ≥18 years of age for patients enrolled in Europe; or ≥20 years of age for patients enrolled in Japan
- •Has definitive histologically or cytologically confirmed SCLC (limited or extensive disease)
- •Has progressed or had recurrence within 30 days prior to randomization
- •Has at least one measurable lesion, as defined by RECIST criteria version 1.1
- •ECOG performance status of 0, 1, or 2
- •Is able to take medications orally
- •Has adequate organ function (bone marrow, kidney and liver)
- •Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
排除标准
- •Has cerebral metastases (unless metastases have been treated and controlled, metastases have been stable for at least 2-months post-intervention, and patient is not receiving corticosteroid treatment)
- •Certain serious illnesses or medical condition(s)
- •Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration
- •Has received TAS-102
- •Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
- •Is a pregnant or lactating female
研究组 & 干预措施
TAS-102
干预措施: TAS-102 (Drug)
Investigator Choice of Amrubicin or Topotecan
Investigator Choice of Amrubicin (Japan only) or Topotecan (Europe and Japan)
干预措施: Amrubicin (Japan) (Drug)
Investigator Choice of Amrubicin or Topotecan
Investigator Choice of Amrubicin (Japan only) or Topotecan (Europe and Japan)
干预措施: Topotecan (Japan/Europe) (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Every 6 weeks from the start of study treatment (Day 1, Cycle 1). Tumor assessments will be performed until radiologic progression develops or the start of new anticancer treatment.
Tumor assessments will be performed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 every 6 weeks during study treatment, and every 8 weeks after treatment is completed. Tumor assessments will be performed from Day 1, Cycle 1 until radiologic progression develops or the start of new anticancer treatment, for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met.
次要结局
- Overall survival(Survival status will be collected at 8-week intervals until death, for up to 12 months after the first dose of study medication for the last patient randomized or until the target number of events (deaths) is met, whichever is later.)
- Safety monitoring including adverse events, vital signs, and laboratory assessments(Through 30 days following last administration of study medication or until initiation of new anticancer treatment)