Intercalated Combination of Erlotinib and Radiotherapy for Patients With EGFR-mutant, Unresectable, Locally Advanced Non-small-cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
The aim of this study is to investigate the efficacy and safety of intercalated combination of erlotinib and radiotherapy for patients with EGFR-mutant, unresectable, locally advanced NSCLC, and to explore a new treatment strategy for this subset. After Induction by erlotinib, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance.
详细描述
Chemoradiation therapy is the standard treatment for unresectable, locally advanced NSCLC, but its efficacy reaches a platform, and treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitors (TKIs) produce a dramatic response in patients carrying EGFR activating mutations in the metastatic setting. Multiple prospective trials show that EGFR-TKIs have a better tolerability when compared with chemotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged ≥18 years.
- •ECOG performance status 0-
- •Pathologically diagnosed of non-small cell lung cancer, and staged as unresectable IIIA/IIIB according the TNM staging system (2009).
- •EGFR activating mutations in exon 18, 19 or 21were detected in tumor tissue or plasma.
- •Measurable disease must be characterized according to RECIST 1.1 criteria.
- •Life expectancy ≥12 weeks.
- •Adequate pulmonary function: FEV1.0 >50% of the normal predicted value, or DLCO >40% of the normal predicted value.
- •Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3.0 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
- •Adequate renal function: serum creatinine ≤
- •5 x ULN, and creatinine clearance ≥ 45 ml/min.
- •Adequate hematological function: Absolute neutrophil count (ANC) ≥1.0 x 109/L, and Platelet count ≥75 x 109/L, and Hemoglobin ≥8 g/dL.
- •Female subjects should not be pregnant or breast-feeding.
- •Written informed consent provided.
- •Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
排除标准
- •Histologically mixed with small-cell lung cancer.
- •Mutations in EGFR exon 20 are detected.
- •Exposure to prior chest irradiation before the enrollment.
- •Patients with prior chemotherapy or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- •History of another malignancy in the last 5 years with the exception of the following: Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted; Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- •Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- •Existence of interstitial lung disease.
研究组 & 干预措施
EGFR-mutant IIIA/IIIB NSCLC
Erlotinib Hydrochloride 150mg daily intercalated with radiotherapy
干预措施: Erlotinib Hydrochloride (Drug)
结局指标
主要结局
Objective response rate
时间窗: Tumor response will be evaluated through study completion, an average of 6 weeks.
assessed by the RECIST 1.1 criteria
次要结局
- Progression free survival（PFS）(Occurrence of local or regional progression, distant metastases, or death from any cause from the time of treatment to the occurrence of one of the failure events, whichever occurs first, assessed up to 10 years.)
- 1 year survival rate(Pts after maintenance phase will receive long-term follow-up including CT scan every 12 weeks for up to 10 years.)
- 3 year survival rate(Pts after maintenance phase will receive long-term follow-up including CT scan every 12 weeks for up to 10 years.)
- Overall survival(Time from treatment to death from any cause, assessed up to 10 years.)
研究者
Huajun CHEN
Principal Investigator
Guangdong Provincial People's Hospital