Phase II Trial of Osimertinib in Combination With Stereotactic Ablative Radiation (SABR) in EGFR Mutant Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Determine efficacy of Osimertinib plus SABR in patients with EGFR mutant lung cancer measured by Progression-Free Survival (PFS)
研究概览
简要总结
This study evaluates the combination of two well-tolerated therapies, osimertinib and Stereotactic Ablative Radiation (SABR).
详细描述
Patients with EGFR mutant non-small cell lung cancer will receive the current optimal therapy with osimertinib. After 8 weeks of targeted therapy, there will likely be some persisting lesions that would not have completely regressed. These persisting lesions would likely consist of cells that are less sensitive to targeted therapy. From the data summarized above [14], these persisting lesions are most to subsequently develop resistance and demonstrate progression.
To delay the onset of clinical progression, lesions that persist after 8 weeks of osimertinib therapy and are amenable to stereotactic ablative radiation will be radiated. Osimertinib will be held for 3 days before the first dose of radiation and resumed 3 days after the last dose.
After radiation, all patients will continue osimertinib therapy. If subsequently there is any evidence of progression, there will be an assessment of whether a repeat course of radiation is feasible. If it is feasible to repeat SABR to sites of progression, this will be performed and osimertinib resumed. If SABR is not possible, then a change in systemic therapy will be required.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Osimertinib
Osimertinib in combination with Stereotactic Ablative Radiation (SABR)
干预措施: Osimertinib (Drug)
Osimertinib
Osimertinib in combination with Stereotactic Ablative Radiation (SABR)
干预措施: SABR (Radiation)
结局指标
主要结局
Determine efficacy of Osimertinib plus SABR in patients with EGFR mutant lung cancer measured by Progression-Free Survival (PFS)
时间窗: Every 8 weeks from the time of first dose of study medication until subject death from any cause, assessed up to 300 weeks.
Progression-Free Survival (PFS) as determined by RECIST 1.1 or death (in the absence of progression).
次要结局
- Determine the impact of Osimertinib plus SABR on survival(From time of first dose of study medication until subject death from any cause, up to 300 weeks.)
- Determine the impact of Osimertinib plus SABR on length of response(Every 8 weeks from time of first dose of study medication until disease progression or death from any cause, assessed up to 300 weeks.)
- Determine the impact of Osimertinib plus SABR on the length of time until next therapy needed(Every 8 Weeks from time of first dose of study medication until subsequent SABR, discontinuation, or disease progression, assessed up to 300 weeks.)
- Determine the impact of Osimertinib plus SABR on tumor response(Every 8 weeks from time of first study medication dose until discontinuation or subject death from any cause, assessed up to 300 weeks.)
- Determine the impact of Osimertinib plus SABR on the duration of time while on Osimertinib(Every 8 weeks from time of first study medication dose until disease progression, discontinuation or subject death from any cause, up to 300 weeks.)
- Number and type of adverse events related to Osimertinib plus SABR as assessed by CTCAE v4.0(From time of first study medication dose through treatment period and including the follow-up period every 4 months following last dose of study medication, until subject death from any cause, up to 48 months.)
研究者
Sawsan Rashdan
Assistant Professor
University of Texas Southwestern Medical Center