Consolidative Stereotactic Radiotherapy for Oligo-Residual Advanced EGFR-Mutant Non-Small Cell Lung Cancer After First-Line Treatment With Third-Generation EGFR Tyrosine Kinase Inhibitor Plus Chemotherapy: A National Multicenter, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 374
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This national multicenter, randomized controlled clinical trial evaluates the safety and efficacy of consolidative stereotactic radiotherapy in patients with advanced EGFR-mutant non-small cell lung cancer who have oligo-residual disease after four cycles of first-line treatment with third-generation EGFR-TKI plus platinum-based pemetrexed chemotherapy. Eligible participants will be randomized 1:1 to continue third-generation EGFR-TKI plus pemetrexed maintenance therapy alone or to receive stereotactic radiotherapy to all oligo-residual lesions in addition to the same maintenance therapy. The primary endpoint is progression-free survival.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-small cell lung cancer.
- •Clinical stage IV disease according to the AJCC 9th edition.
- •Sensitizing EGFR mutation: EGFR exon 19 deletion or EGFR L858R.
- •Age 18-75 years.
- •Karnofsky Performance Status score ≥
- •Complete whole-body imaging assessment before initiation of first-line third-generation EGFR-TKI plus chemotherapy, with at least one evaluable lesion according to RECIST version 1.
- •No disease progression after completion of four cycles of first-line third-generation EGFR-TKI plus chemotherapy and no unresolved grade ≥3 nonhematologic toxicity.
- •Oligo-residual disease after four treatment cycles, with all residual lesions considered suitable for stereotactic radiotherapy by the investigator.
- •Written informed consent.
排除标准
- •Double primary or multiple primary malignancies, except early skin cancer or cervical carcinoma in situ treated with curative intent and without recurrence or progression for at least five years.
- •Pregnancy or breastfeeding, or considered unsuitable by the investigator for PET/CT or brain MRI examination.
- •History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder that, in the investigator's judgment, may interfere with informed consent or participant compliance.
- •Residual lesions considered unsuitable for consolidative stereotactic radiotherapy after first-line third-generation EGFR-TKI plus chemotherapy.
研究组 & 干预措施
Radiotherapy plus TKI Group
Consolidative stereotactic radiotherapy plus continued third-generation EGFR-TKI and pemetrexed maintenance therapy.
干预措施: Third-generation EGFR tyrosine kinase inhibitor (Drug)
Radiotherapy plus TKI Group
Consolidative stereotactic radiotherapy plus continued third-generation EGFR-TKI and pemetrexed maintenance therapy.
干预措施: Platinum plus pemetrexed chemotherapy (Drug)
Radiotherapy plus TKI Group
Consolidative stereotactic radiotherapy plus continued third-generation EGFR-TKI and pemetrexed maintenance therapy.
干预措施: Pemetrexed maintenance therapy (Drug)
Radiotherapy plus TKI Group
Consolidative stereotactic radiotherapy plus continued third-generation EGFR-TKI and pemetrexed maintenance therapy.
干预措施: Consolidative stereotactic radiotherapy (Radiation)
TKI alone Group
Continued third-generation EGFR-TKI and pemetrexed maintenance therapy alone.
干预措施: Third-generation EGFR tyrosine kinase inhibitor (Drug)
TKI alone Group
Continued third-generation EGFR-TKI and pemetrexed maintenance therapy alone.
干预措施: Platinum plus pemetrexed chemotherapy (Drug)
TKI alone Group
Continued third-generation EGFR-TKI and pemetrexed maintenance therapy alone.
干预措施: Pemetrexed maintenance therapy (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 4 years
The time from randomization to disease progression or death of the patient. Patients who have not yet progressed at the time of analysis will be censored at the date of their last contact.
次要结局
- Overall Survival (OS)(4 years)
- Intracranial Progression-Free Survival (iPFS)(4 years)
- Health-Related Quality of Life (HRQoL)(4 years)
- Incidence of Treatment-Related Toxicities(4 years)