A Pilot Study of Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 主要终点
- PFS
研究概览
简要总结
This is a Phase II, multi-center pilot study assessing the efficacy and safety of durvalumab combined with chemotherapy and stereotactic body radiotherapy (SBRT) in patients with oligo-metastatic non-small cell lung cancer (NSCLC).
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 80 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
- •≤3 metastatic organs and ≤5 metastatic lesions (supraclavicular and mediastinal lymph nodes are not classified as distant metastasis; other lymph node
- •metastasis 一 group lymph node region will be classified as one metastatic lesion）
- •Tissue biopsy prior to treatment
- •ECOG performance score 0-1
排除标准
- •EGFR mutation or ALK positive.
- •Evidence on pulmonary interstitial disease or symptoms of active non-infectious pneumonia.
- •Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
- •Previous treatment with antibody against pd -1, pd - L1, pd - L2, CD137 or CTLA-4 (including ipilimumab or any antibody or drug against T cell co-stimulation or checkpoint pathway).
研究组 & 干预措施
Durvalumab therapy
Chemo+Durvalumab (PD-L1 monoclonal antibody)1500 mg every 3 weeks [q3w] intravenously [iv] for 4 cycles, then SBRT 50-60 Gy/≤10f + Durvalumab 1500 mg q4w, then Durvalumab 1500 mg q4w for up to 24 months or until progression or other discontinuation criteria are met.
干预措施: Durvalumab (Drug)
Durvalumab therapy
Chemo+Durvalumab (PD-L1 monoclonal antibody)1500 mg every 3 weeks [q3w] intravenously [iv] for 4 cycles, then SBRT 50-60 Gy/≤10f + Durvalumab 1500 mg q4w, then Durvalumab 1500 mg q4w for up to 24 months or until progression or other discontinuation criteria are met.
干预措施: the first line chemotherapy for metastatic NSCLC (Drug)
Durvalumab therapy
Chemo+Durvalumab (PD-L1 monoclonal antibody)1500 mg every 3 weeks [q3w] intravenously [iv] for 4 cycles, then SBRT 50-60 Gy/≤10f + Durvalumab 1500 mg q4w, then Durvalumab 1500 mg q4w for up to 24 months or until progression or other discontinuation criteria are met.
干预措施: stereotactic body radiotherapy (SBRT) (Radiation)
结局指标
主要结局
PFS
时间窗: up to 2 years
Progression-Free Survival (PFS) assessed according to RECIST 1.1 in subpopulation of patients with oligometastatic NSCLC
次要结局
- Objective response rate(ORR)(up to 2 years)
- and OS Overall Survival(OS)(up to 2 years)
- Safety (AESI, AEs/SAEs)(up to 2 years)
- To assess the treat failure patterns(up to 2 years)