Prospective, Multicentre Phase II Clinical Study of Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- security
研究概览
简要总结
This study is aimed at patients with unresectable NSCLC who take nintedanib during sequential radiotherapy to explore the incidence of radiation pneumonitis above grade 2 in the nintedanib combined with radiotherapy mode and observe safety. And will further explore the progression-free survival (PFS) and overall survival (OS) of patients treated with nintedanib in combination with radiotherapy and immunotherapy.
Primary objective: To evaluate the safety of nintedanib combined with sequential radiotherapy in patients with unresectable NSCLC and the incidence of radiation pneumonitis above grade 2. Secondary objective: To evaluate the changes in lung function, progression-free survival (PFS) and overall survival (OS) in patients with unresectable NSCLC after nintedanib combined with sequential radiotherapy.
Patients need to receive induction therapy, chemotherapy and/or immunotherapy for at least one cycle. Then they will receive sequential radiotherapy and nintedanib for 6 months. Finally, they will receive immunotherapy maintenance therapy for 16 cycles.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Men or women who are over 18 years old (including 18 years old) when signing the informed consent form;
- •Non-small cell lung cancer was confirmed by histology and could not be resected, and EGFR/ALK driver gene was confirmed negative by gene mutation examination;
- •At least one measurable lesion with imaging examination (according to RECIST1.1) is examined by spiral CT or MR, and the length and diameter of the lesion are ≥ 10 mm;
- •within 3 days before treatment, the score according to ECOG is 0 ~ 1;
- •Life expectancy ≥3 months;
- •The vital organs function well,
- •The subjects volunteered to join the study and signed the informed consent form, with good compliance and cooperation with the follow-up.
排除标准
- •Complicated with severe respiratory diseases: pulmonary fibrosis, active tuberculosis, etc.
- •Persons with mental disorder, blood system diseases, autoimmune diseases and serious primary diseases of heart, brain, liver and kidney;
- •Hemorrhagic events that require blood transfusion, invasive intervention or hospitalization occur within 3 months before the first administration, or there are bleeding symptoms and need intervention treatment (such as hemoptysis, hematuria and bloody stool), or high-risk factors with bleeding risk (such as tumor surrounding or invading important blood vessels, obvious necrosis or cavity around tumor, esophageal varices, etc.);
- •Thrombosis or embolic diseases, abnormal blood coagulation function and bleeding tendency;
- •Known or suspected to be allergic to the study drug and its auxiliary materials;
- •The baseline pregnancy test of pregnant and lactating women or fertile women is positive.
- •According to the researcher's judgment, the subjects have other factors that may lead to the forced termination of this study.
结局指标
主要结局
security
时间窗: Up to 2 years
Incidence of adverse events
Incidence rate of radiation pneumonia
时间窗: Up to 2 years
Incidence of grade 2 and above radiation pneumonia
次要结局
- Overall Survival (OS)(Up to 2 years)
- Pulmonary function index(Up to 2 years)
- Progression-free Survival (PFS)(Up to 2 years)
研究者
Gang Jin
Director
Second Hospital of Shanxi Medical University