Real-world Survival Outcomes and the Evaluation of Optimal Strategies for Immuno-Radiotherapy in Advanced Non-Small-Cell Lung Cancer: a Territory-wide Study (OCEANUS Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- OS (overall survival)
研究概览
简要总结
The optimal combination strategy for radiotherapy combined with immunotherapy (iRT) in advanced non-small-cell lung cancer (NSCLC) remains unclear, and there is a lack of real-world data to validate its efficacy. The objective of this study is to confirm the survival benefits of iRT in advanced NSCLC and to identify the optimal combination strategy for its use.
详细描述
The PACIFIC study has established radiotherapy combined with immune checkpoint inhibitors (iRT) as the primary treatment modality for unresectable, locally advanced non-small-cell lung cancer (NSCLC). Simultaneously, the KEYNOTE-001 study provided evidence supporting the efficacy of iRT in patients with metastatic and progressive NSCLC. However, most available evidence comes from interventional clinical trials, where participants are rigorously selected and required to adhere strictly to protocol-defined interventions. This creates a significant gap in real-world data, which is essential to further validate the survival benefits of iRT in advanced NSCLC. Furthermore, clinical trials evaluating concurrent iRT in NSCLC have largely yielded negative or inconclusive results, highlighting the need for clarity on the optimal combination strategy for iRT.
To address these gaps, researchers will conduct a territory-wide real-world cohort study. The objective of this study is to validate the survival benefits of iRT in patients with advanced NSCLC and to identify the optimal sequential strategy for iRT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSCLC patients who received immunotherapy between 2015 and 2021
- •For unresectable locally advanced NSCLC: definitive thoracic radiotherapy must have been administered as the initial treatment, with immunotherapy initiated within 90 days after RT or concurrently with RT
- •For de novo metastatic NSCLC: radiotherapy targeting the primary lung tumor or metastatic lesions must have been administered as the initial treatment, with immunotherapy initiated within 90 days after RT or concurrently with RT
- •For post-treatment progressive NSCLC: salvage radiotherapy must have been performed during immunotherapy or within 90 days after the cessation of immunotherapy
- •Age >= 18 years old
排除标准
- •Patients with multiple primary cancers or a pathological diagnosis of small cell lung cancer
- •Patients who did not receive radiotherapy or who did not undergo radiotherapy within 90 days before or after immunotherapy
研究组 & 干预措施
initial iRT for locally advanced NSCLC
For unresectable locally advanced NSCLC: definitive thoracic radiotherapy must have been administered as the initial treatment, with immunotherapy initiated within 90 days after RT (Sequential iRT) or concurrently with RT (Concurrent iRT).
干预措施: initial Sequential iRT (Drug)
initial iRT for locally advanced NSCLC
For unresectable locally advanced NSCLC: definitive thoracic radiotherapy must have been administered as the initial treatment, with immunotherapy initiated within 90 days after RT (Sequential iRT) or concurrently with RT (Concurrent iRT).
干预措施: initial Concurrent iRT (Drug)
initial iRT for de novo metastatic NSCLC
For de novo metastatic NSCLC: radiotherapy targeting the primary lung tumor or metastatic lesions must have been administered as the initial treatment, with immunotherapy initiated within 90 days after RT (Sequential iRT) or concurrently with RT (Concurrent iRT).
干预措施: initial Sequential iRT (Drug)
initial iRT for de novo metastatic NSCLC
For de novo metastatic NSCLC: radiotherapy targeting the primary lung tumor or metastatic lesions must have been administered as the initial treatment, with immunotherapy initiated within 90 days after RT (Sequential iRT) or concurrently with RT (Concurrent iRT).
干预措施: initial Concurrent iRT (Drug)
Salvage iRT in post-treatment progressive NSCLC
For post-treatment progressive NSCLC: salvage radiotherapy must have been performed during immunotherapy or within 90 days after the cessation of immunotherapy (RT after discontinuation of ICI) , or concurrently with RT (RT with maintenance of ICI).
干预措施: RT with maintenance of ICI (Drug)
Salvage iRT in post-treatment progressive NSCLC
For post-treatment progressive NSCLC: salvage radiotherapy must have been performed during immunotherapy or within 90 days after the cessation of immunotherapy (RT after discontinuation of ICI) , or concurrently with RT (RT with maintenance of ICI).
干预措施: RT after discontinuation of ICI (Drug)
结局指标
主要结局
OS (overall survival)
时间窗: From the initiation date of iRT to the date of death from any cause, with a follow-up period of up to approximately 5 years.
OS is defined as the time from the initiation of iRT until death from any cause.
次要结局
未报告次要终点
研究者
Fengming Kong
professor
The University of Hong Kong-Shenzhen Hospital