A Prospective Cohort Observational Study of Local Therapy for the Primary Tumor in EGFR-Mutant Advanced Non-Small Cell Lung Cancer Following Osimertinib Plus Chemotherapy (FLAURA2 Regimen)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Median progression-free survival (PFS)
研究概览
简要总结
This is a single-arm, open-label, phase II study evaluating the clinical outcomes of local therapy (surgery or radiotherapy) to the primary tumor in patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC) who have achieved disease control following first-line treatment with the FLAURA2 regimen (osimertinib plus platinum-based chemotherapy). The primary objective is to assess the median progression-free survival (PFS) after local therapy.
详细描述
This prospective, single-arm, multicenter observational study is designed to estimate the median progression-free survival (PFS) in patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC) who receive salvage local treatment after achieving disease control with first-line osimertinib plus chemotherapy. A total of 70 patients will be enrolled. The primary endpoint is median PFS, and the sample size was calculated to ensure that the 95% confidence interval around the estimated median has a width of no more than ±3 months, using Greenwood's approximation. Patients will be followed for a minimum of 24 months after the last enrollment, with an overall study duration of up to 72 months.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •\ Participants must meet all of the following criteria to be eligible:
- •1. Age ≥ 20 years at the time of consent.
- •2. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
- •3. Presence of activating EGFR mutation (exon 19 deletion or L858R).
- •4. Stage IV (metastatic) NSCLC at initial diagnosis.
- •5. Completion of four cycles of first-line osimertinib plus platinum-based chemotherapy (FLAURA2 regimen).
- •6. Radiologic evidence of disease control (complete response, partial response, or stable disease) after systemic therapy.
- •7. Residual primary lung tumor suitable for local therapy (surgery or radiotherapy), as determined by multidisciplinary evaluation.
- •8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •9. Adequate organ function based on institutional laboratory criteria.
- •10. Ability to understand and willingness to provide written informed consent.
排除标准
- •Participants will be excluded if they meet any of the following criteria:
- •Radiologic or clinical evidence of progressive disease during first-line osimertinib-chemotherapy.
- •Extensive, unresectable metastatic disease not amenable to local therapy.
- •Untreated or clinically unstable brain metastases.
- •Known contraindications to surgery or radiotherapy.
- •Active second malignancy requiring concurrent treatment.
- •Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results.
- •Pregnancy or breastfeeding at the time of enrollment.
研究组 & 干预措施
Local Therapy Arm
Patients with EGFR-mutant advanced non-small cell lung cancer who achieve disease control after first-line osimertinib plus chemotherapy (FLAURA2 regimen) will receive local therapy (surgery or radiotherapy) to the primary tumor. The study will evaluate clinical outcomes including progression-free survival, overall survival, and treatment-related toxicity.
干预措施: Local Therapy (Surgery or Radiotherapy) (Other)
结局指标
主要结局
Median progression-free survival (PFS)
时间窗: Up to 60 months (through June 30, 2030; patients followed for ≥24 months after last enrollment)
Time from the initiation of local therapy to the date of radiographic or clinical disease progression or death from any cause, whichever occurs first. Median PFS will be estimated using the Kaplan-Meier method.
次要结局
- Local Control Rate(Up to 60 months (through June 30, 2030))
- Overall survival (OS)(Up to 72 months (through June 30, 2031))
- Adverse events (AEs)(Up to 60 months (through June 30, 2030))