An Open-label, Single-Arm, Phase 2 Trial of Stereotactic Radiotherapy for Patients With Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This study is an open-label, single-arm phase 2 trial to evaluate the efficacy and safety of stereotactic radiotherapy (SRT) for patients with oligo-residual NSCLC after 3rd generation EGFR-TKIs.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration.
- •The patient has a diagnosis of American Joint Committee on Cancer (AJCC) 8th Edition stage IV NSCLC.
- •The patient receives 3rd generation EGFR-TKI in the first line setting.
- •The patient is ≥18 years of age and ≤75 years of age at the time of screening.
- •The patient's Karnofsky performance score (KPS) is ≥70 at study entry.
- •The patient has adequate baseline tumor assessment before initiation of 3rd generation EGFR-TKI.
- •The patient has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.
- •The patient presents with a residual "oligometastatic" state after 3rd generation EGFR-TKI therapy that would be amenable to consolidative SRT in the opinion of the investigator.
- •The patient has signed informed consent.
- •EGFR Exon19 deletion or Exon21 L858R mutation
排除标准
- •History of another malignancy or concurrent malignancy. Patients with cervical carcinoma in situ or adequately treated basal cell carcinoma who have been disease free for > 5 years are eligible.
- •The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
- •Patients with uncontrolled epilepsy, mental disorders, drug abuse, or social condition that may affect compliance or ability to sign a written informed consent in the opinion of the investigator.
- •Patients with residual metastatic disease after 3rd generation EGFR-TKI therapy that is deemed not amenable to consolidative SRT.
研究组 & 干预措施
3rd generation EGFR-TKI+ SRT
Patients were treated with the intent to ablate all residual disease with consolidative SRT. EGFR-TKI treatment was continued during and after consolidative SRT until disease progression or intolerable toxicity.
干预措施: 3rd generation EGFR-TKI (Drug)
3rd generation EGFR-TKI+ SRT
Patients were treated with the intent to ablate all residual disease with consolidative SRT. EGFR-TKI treatment was continued during and after consolidative SRT until disease progression or intolerable toxicity.
干预措施: Consolidative SRT (Radiation)
结局指标
主要结局
Progression Free Survival
时间窗: Two years
PFS was measured from the date of enrollment to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death due to any cause, whichever occurred first. For patients whose disease did not progress, PFS was evaluated by censoring patients at their most recent imaging.
次要结局
- Percentage of Participants With Adverse Events(Two years)
- Overall Survival(Two years)