Phase III, Multicenter, Randomized Controlled Clinical Study of Three-Dimensional Radiotherapy for Primary Tumors in Non-Oligometastatic Stage IV Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Overall Survival, Local regional progressive-free survival, LRPFS
研究概览
简要总结
For patients with non-small cell lung cancer and more than five metastatic lesions (non-oligometastatic disease), does radical treatment of the primary lung lesion, in addition to pharmacotherapy, also provide benefits in terms of progression-free survival (PFS) and local control? Currently, there is limited clinical research on combining pharmacotherapy with radiotherapy for the primary lesion in non-oligometastatic patients. Therefore, this study aims to investigate whether radical radiotherapy targeting the primary lung lesion, in addition to pharmacotherapy, can improve local control and survival in non-oligometastatic patients, and whether the associated toxicities are acceptable.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically or cytologically confirmed stage IV NSCLC [9th edition, 2024];
- •Non-oligometastatic disease (number of metastatic lesions > 5, regardless of the number of organs involved); patients with brain metastases must be conscious; the number of lung metastases must not affect lung function and allow for possible primary tumor radiotherapy;
- •Treatment-naïve (no prior antitumor therapy); or disease control after 1-3 months of monotherapy with TKI, ALK inhibitor/ROS inhibitor; or disease control after 4-6 cycles of chemotherapy combined with immunotherapy;
- •Age 18-80 years, ECOG 0-2 or KPS ≥70; no contraindications to radiotherapy, EGFR-TKI, ALK/ROS1 inhibitors, chemotherapy, or immunotherapy;
- •No major organ dysfunction, or laboratory test results must meet the following criteria: Hematology , cardiac function, liver function , and renal function within normal ranges according to respective laboratory standards. Pulmonary function : FEV1 >50%, mild to moderate impairment of lung function.
- •Signed informed consent before treatment (for radiotherapy, chemotherapy, immunotherapy, and targeted drug therapy);
- •Good patient compliance with the treatment and follow-up.
排除标准
- •Stage I-III NSCLC, oligometastasis (number of metastatic lesions ≤ 5), Stage IV NSCLC with malignant serous cavity effusion, or KPS ≤ 60;
- •Patients with extensive liver metastases or lung metastases that have severely impaired liver or lung function;
- •Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, symptomatic congestive heart failure within the past 12 months, or uncontrolled arrhythmia; clinically diagnosed valvular heart disease; active bacterial, fungal, or viral infections; mental disorders; severe pulmonary dysfunction;
- •Pregnant or lactating patients;
- •Patients with a history of other active malignant tumors prior to enrollment, except for non-small cell lung cancer; excluding non-melanoma skin basal cell carcinoma, cervical carcinoma in situ, and cured early-stage prostate cancer;
- •Patients with allergic constitution or known/suspected allergy to any investigational drugs without alternative medications;
- •Patients with poor compliance; Patients deemed unsuitable for participation in this trial by the investigator.
研究组 & 干预措施
Pharmacotherapy group
For patients positive for driver gene mutations, first-line targeted therapy with or without chemotherapy is recommended according to NCCN guidelines. For patients negative for driver gene mutations, first-line immunotherapy combined with chemotherapy is recommended according to NCCN guidelines.
Radiotherapy group
For patients positive for driver gene mutations, first-line targeted therapy with or without chemotherapy is recommended according to NCCN guidelines. For patients negative for driver gene mutations, first-line immunotherapy combined with chemotherapy is recommended according to NCCN guidelines. Concurrent radiotherapy for the primary tumor in combination with drug therapy.
干预措施: Three-Dimensional Radiotherapy for Primary lungTumors (Radiation)
结局指标
主要结局
Overall Survival, Local regional progressive-free survival, LRPFS
时间窗: From enrollment to the end of treatment at 1 year
OS refers to the period the date of randomization in a clinical trial until the patient dies from any cause. Local progression-free survival time refers to the duration from randomization until the first occurrence of local progression at the primary tumor site or region, or death from any cause
次要结局
- ORR,(From enrollment to the end of treatment at 1year.)
- PFS(From enrollment to the end of treatment at 1 year)
- Toxicities(From enrollment to the end of treatment at 1 year)