A Phase II Single-arm Study of Furmonertinib Combined With Radiotherapy for Non-small Cell Lung Cancer With Oligoprogression After First-line EGFR-TKI Therapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
This Phase II randomized study is to explore the efficacy and safety of Furmonertinib combined with radiotherapy for non-small cell lung cancer with oligoprogression after first-line EGFR-TKI therapy.
详细描述
This Phase II randomized study is to explore the efficacy and safety of Furmonertinib combined with radiotherapy for non-small cell lung cancer with oligoprogression after first-line EGFR-TKI therapy.
The first group will enroll NSCLC patients with oligoprogression after using the first/second generation EGFR-TKI. The participants will receive Furmonertinib 80mg and local radiotherapy as the following therapy.
The other group will enroll NSCLC patients with oligoprogression after using the third generation EGFR-TKI. The participants will receive Furmonertinib 160mg and local radiotherapy as the following therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with locally advanced or metastatic NSCLC who are diagnosed by histology or cytology and are not suitable for surgery or radiotherapy;
- •After receiving the first or second generation of EGFR-TKI treatment, the disease is oligoprogressive with 3-5 lesions (with imaging evidence), and the mutation is T790M+ (histological or hematological specimens, ARMS detection method);
- •After receiving osimertinib treatment in the past, the disease is oligoprogressive with 3-5 lesions (with imaging evidence), and the patient refused chemotherapy;
- •18-80 years old;
- •ECOG PS 0-2 scores;
- •Organ and bone marrow functions were generally normal within 30 days before enrollment, including:AST, ALT ≤ 2.5 × ULN or ≤ 5 × ULN (with liver metastasis); total bilirubin ≤ 1.5 × ULN; neutrophils absolute value ≥ 1500 cells/mm3; Creatinine clearance ≥45 mL/min; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥90g/L.
- •The baseline has measurable lesions defined by the RECIST 1.1 standard, and the progressive lesions should be treated with local radiotherapy; the definition of the lesion number includes:
- •When there are lesions on both adrenal glands, it is considered to be 2 metastases;
- •Two consecutive vertebral lesions and a paravertebral lesion within 6 cm can be considered as one metastasis, and the non-contiguous vertebral lesions should be counted separately;
- •The adjacent lesions in the liver, lung, and mediastinum can be considered as a metastasis if one isocenter can be used for irradiation;
- •Intracranial lesions are counted as 1 metastasis.
- •The patient signed an informed consent form.
排除标准
- •Severe or uncontrolled hypertension, diabetes, coronary artery stenosis, aortic dissection, aneurysm or acute bleeding disease;
- •Any situation that increases the risk of QTc prolongation or arrhythmia;
- •Left ventricular ejection fraction <50%;
- •History of interstitial lung disease;
- •FEV1%<30% or DLCO%<40%;
- •Insertion of EGFR exon 20;
- •The researcher believes that the patient is inappropriate to participate in this trial.
研究组 & 干预措施
Furmonertinib 80mg combined with radiotherapy
This group will enroll NSCLC patients who are oligoprogressive after first/second generation EGFR-TKI therapy. These patients will receive furmonertinib 80mg combined with radiotherapy as following therapy.
干预措施: Furmonertinib (Drug)
Furmonertinib 160mg combined with radiotherapy
This group will enroll NSCLC patients who are oligoprogressive after third generation EGFR-TKI therapy. These patients will receive furmonertinib 160mg combined with radiotherapy as following therapy.
干预措施: Furmonertinib (Drug)
结局指标
主要结局
progression-free survival
时间窗: 2-year
From the first day of treatment to the day of progression or the day of death.
次要结局
- Overall survival(2-year)
- Failure pattern(2-year)
- Safety evaluation(2 year after therapy)
研究者
Hui Liu
Professor
Sun Yat-sen University