Hybrid Dose-fraction Radiotherapy for Metastatic Driven-genes Negative Non-small Cell Lung Cancer: A Phase II Multi-institutional Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
The combination of immune checkpoint inhibitors (ICI) and local ablative radiotherapy has been demonstrated to be able to increase the survival of patients with metastatic driven-genes negative non-small cell lung cancer. Various dose-fraction of radiotherapy could exert different effects on the immune system. Ablative-dose could induce immunogenic cell death through the activation of CD8+(Cluster of Differentiation) T cells. Low-dose could modulate immune microenvironment from immunosuppression to inflammatory anti-tumor phenotype. This trial is designed to validation the safety and primary efficacy of the combination of hybrid dose-fraction radiotherapy with ICI for metastatic driven-genes negative non-small cell lung cancer patients.
详细描述
Trial Title: Hybrid dose-fraction Radiotherapy for metastatic driven-genes negative non-small cell lung cancer: A phase II multi-institutional study Trial Objective: To explore the safety and primary efficacy of the combination of hybrid dose-fraction radiotherapy with ICI for metastatic driven-genes negative non-small cell lung cancer patients.
Trial Design: This trial is designed to enroll 74 patients with metastatic driven-genes negative non-small cell lung cancer to receive the combination of hybrid dose-fraction radiotherapy with ICI.
Staging Examination before Radiotherapy: a. ECOG scoring. b. Cranial contrast MRI and PET-CT (Positron Emissions Tomography), or cranial contrast MRI (preferred), chest contrast CT, abdominal ultrasonography and bone scan. c. Bronchoscopy for centrally located lung cancer.
Inductive therapy ICI±chemotherapy for 4-6 cycles. Pembrolizumab and Tislelizumab are preferred. Chemotherapy regimens could be referred to NCCN (National Comprehensive Cancer Network) guidelines.
Restaging examination after inductive therapy is mandatory: a. ECOG scoring. b. Cranial contrast MRI, chest contrast CT, abdominal ultrasonography.
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
- •18-75 years old;
- •Eastern Cooperative Oncology Group (ECOG) 0-1;
- •Non-small cell lung cancer, including squamous-cell carcinoma, adenocarcinoma, large-cell carcinoma, adenosquamous carcinoma;
- •Stage IVA and IVB confirmed by radiological examination (AJCC 8th Edition);
- •Driven-genes negative including EGFR (Epidermal Growth Factor Receptor), ALK (Anaplastic Lymphoma Kinase), ROS1 (ROS Proto-Oncogene 1), KRAS G12C (Kirsten Rat Sarcoma Viral Oncogene), BRAF V600E (v-raf murine sarcoma viral oncogene homolog B1), MET exon14 (Mesenchymal Epithelial Transition Factor), RET (Rearranged during Transfection Proto-oncogene), NTRK1/2/3 (NeuroTrophin Receptor Kinase);
- •First-line treatment of ICI±chemotherapy;
- •Partial response (PR) or stable (SD) after first-line treatment;
- •Signature of inform consent.
排除标准
- •younger than 18 years old or older than 75 years old;
- •Small-cell lung cancer and other neuroendocrine carcinoma;
- •Non stage IV confirmed by radiological examination;
- •Driven-genes positive including EGFR, ALK, ROS1, KRAS G12C, BRAF V600E, MET exon14, RET, NTRK1/2/3;
- •First-line treatment of other therapy rather than ICI±chemotherapy;
- •Complete response (CR) or progression (PD) after first-line treatment;
- •Contraindications for radiotherapy, chemotherapy and ICI;
- •No signature of inform consent.
研究组 & 干预措施
Hybrid dose-fraction Radiotherapy Arm
Patients in this arm would receive hybrid dose-fraction radiotherapy combined with immune checkpoint inhibitors.
干预措施: Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: 1-year
Progression-free Survival evaluated by RECIST (v1.1)
次要结局
未报告次要终点
研究者
Dong Qian
Professor
Anhui Provincial Hospital