An Open-label, Single-arm Clinical Study to Evaluate the Efficacy of Afatinib in Advanced Lung Squamous Cell Carcinoma With EGFR Sensitive Mutation
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This is an open-label, sing-arm, single site, phase IV clinical study. The main objective is to evaluate the efficacy of afatinib in LSQC patients with EGFR sensitive mutation, and to explore the clinical factors which might be predictive for the effectiveness in LSQC.
详细描述
This is an open-label, sing-arm phase IV clinical study which will recruit about 20 patients in China.
The main objective of this study is to evaluate the efficacy of afatinib in LSQC patients with EGFR sensitive mutation, and to explore the clinical factors which might be predictive for the effectiveness in LSQC.
Target patient population:Locally advanced (IIIB) or metastatic (stage IV) immunohistochemistry (IHC)-verified Lung squamous cell carcinoma (LSQC) with EGFR sensitive mutation patients, whom previously untreated or received platinum-based doublet chemotherapy as first-line treatment with subsequent disease progression, and had to be eligible for second-line treatment.
Investigational product, the dose and administration method: Afatinib is a member of the second generation TKIs, which binds irreversibly to the erbB family of receptors. Afatinib will be administrated orally with the starting dose of 40 mg tablets, once per day. If patients can't tolerate drug related AEs with 40mg, patients can receive 30mg once per day after AEs recovered to Grade 0-1 (CTCAE 5.0).
Study assessment: The collected data include the patient's demographic characteristics, information needed to determine whether the patient is eligible (including medical history, attributes of previous and current disease, and EGFR mutation status in tumor tissues), efficacy of objective response rate(ORR), progression-free survival (PFS), overall survival (OS), and safety (including serious adverse events and dose change-induced adverse events).
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
- •Selected patients must meet all of the following standards:
- •The patient's or his/her legal representative's has signed and dated written informed consent before any specific study procedure.
- •The patient is above 18 years old.
- •Locally advanced (IIIB) or metastatic (stage IV) immunohistochemistry (IHC)-verified Lung squamous cell carcinoma (LSQC) with EGFR sensitive mutation patients, whom previously untreated or received platinum-based doublet chemotherapy as first-line treatment with subsequent disease progression, and had to be eligible for second-line treatment.
- •The patient has NOT previously received EGFR-TKI treatment.
- •ECOG Performance Status Score is 0~
- •The patient has sufficient bone marrow and organ function proved by baseline complete plasma count, plasma biochemistry and urinary biochemistry tests.
- •Female patients of childbearing age must use adequate contraceptives, and breastfeeding is not allowed.
- •Male patients must voluntarily to use contraceptives.
- •Exclusion criteria
- •Selected patients can not meet any one of the following standards:
- •The patient has received EGFR-TKI treatment.
- •The patient has any severe or uncontrolled systemic signs of illness, including uncontrolled hypertension, active easy-bleeding constitution, active infection, or significantly impaired function of bone marrow or organs, which researchers believe can significantly change the patient's risk/benefit balance.
- •The patient has symptomatic central nervous system (CNS) metastases.
- •The patient has the history of interstitial pneumonia, or radiation pneumonia which needs steroid treatment.
- •The patient still has unrecovered toxic reaction with ≥ grade 3 (CTCAE5.0) caused by previously received treatment.
排除标准
- 未提供
研究组 & 干预措施
Afatinib treatment group
This is an open-label, sing-arm phase IV clinical study
干预措施: Afatinib (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Up to 12 months
PFS refers to the time from initial prescription of afatinib to the time of disease progression or death recorded in CRF in this study, no matter whether the patient withdraw from the treatment before disease progression or receive other anti-cancer treatment or not. For the patient without progression or death at the time of analysis, the latest assessment date will be used as interpolation (censoring). (Or, if there's no tumor assessment after baseline visit, baseline visit date will be used
次要结局
- Overall survival (OS)(Up to 12 months)
- Objective response rate (ORR)(Up to 12 months)
- Rate of SAEs, dose change-induced AEs, and AEs of particular concerns.(Up to 12 months)
研究者
Lu Shun
Chief physician
Shanghai Chest Hospital