Almonertinib With Concurrent Radiotherapy in The Treatment of Unresectable, Stage Ⅲ Non-small-cell Lung Cancer Harboring EGFR Mutations: A PhaseⅡCohort Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- RP(≥3)
研究概览
简要总结
Previous clinical studies showed there is a potential value of EGFR-TKI in local advanced EGFR-mutant NSCLC, while the risk of radiation pneumonia in combination of EGFR-TKI with thoracic radiotherapy is unknown. This study aims to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI drug, with radiotherapy in local advanced EGFR-mutant NSCLC patients.
详细描述
Doublet platinum-based therapy combined with radiotherapy remains the standard treatment for first-line management of unresectable stage III NSCLC patients, regardless of the EGFR mutation status. But the 5-year survival rate is not satisfying. Previous clinical studies showed there is a potential value but also a high risk of radiation pneumonia in treatment regimens of combination TKI with radiotherapy. This study intends to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI drug, with radiotherapy in EGFR-sensitive mutated locally advanced NSCLC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed histologically or pathologically as non-small cell lung cancer;
- •According to the eighth edition of the 2015 IASLC international lung cancer staging, imaging staging assessed as inoperable stage III patients (according to the eighth edition of the 2015 IASLC international lung cancer staging);
- •Blood or tissue EGFR detection is Exon 19 deletion or L858R mutation;
- •Have not received systemic anti-tumor therapy;
- •FEV1>0.75L;
- •Age ≥ 18 years old;
- •ECOG PS score ≤ 2;
- •Estimated survival period ≥ 6 months;
- •Women must undergo surgical sterilization, post-menopausal, or take contraceptive measures during the treatment period and within 3 months after the end;
- •Sign the informed consent form.
排除标准
- •Previously received other anti-tumor treatment, including almonertinib or other EGFR-TKI drugs;
- •Contraindications for radiotherapy such as uncontrolled systemic lupus erythematosus, scleroderma or other connective tissue diseases;
- •Other malignant tumors within 5 years (except for non-melanoma skin cancer and cervical cancer);
- •Any medical or non-medical reasons prevent the patient from continuing to participate in the research;
- •It is expected that the patient will not be able to comply with the research procedures, restrictions and requirements, and researchers determine that the patient is not suitable for participating in the trial;
- •Currently receiving (or unable to stop using it before receiving the first dose of study treatment) drugs or herbal supplements known to be potent inducers of CYP3A4 (at least 3 weeks ago);
- •The patient is taking any drugs that prolong the QT interval, and the drug cannot be stopped before the treatment of almonertinib;
- •Patients with lung V20 > 28% even after two-month almonertinib treatment.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Induction group
If the lung V20 of initial radiation plan is equal to or more than 28%, then the patient will receive 2 months almonertinib before concurrent thoracic radiotherapy
干预措施: Almonertinib (Drug)
Concurrent group
If the lung V20 of initial radiation plan is less than 28%, then the patient will receive concurrent thoracic radiotherapy with almonertinib.
干预措施: Almonertinib (Drug)
结局指标
主要结局
RP(≥3)
时间窗: 6 months
incidence of radiation pneumonitis (≥ grade 3) within 6 month after Radiotherapy
次要结局
- LCR(1 years)
- PFS(2 years)
- OS(2 years)