ERLOTINIB, A TYROSINE KINASE INHIBITOR OF EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) AS FIRST LINE TREATMENT, IN PATIENTS WITH LOCALLY ADVANCED/METASTATIC NON SMALL CELL LUNG CANCER (NSCLC). A PHASE II STUDY
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Overall Response Rate
研究概览
简要总结
To evaluate the efficacy and toxicity of erlotinib as first line treatment in patients with locally advanced/metastatic (stages IIIB/IV) NSCLC, with clinical predictors of response to tyrosine kinase inhibitors (erlotinib, gefitinib), such as female gender, never-smoking status and adenocarcinoma histology. Furthermore, erlotinib-sensitivity will be correlated with the presence of EGFR mutations in exons 18, 19 and 21, in this population
详细描述
A randomized, placebo-controlled phase III trial of erlotinib versus placebo, with more than 700 patients demonstrated that therapy with this tyrosine kinase inhibitor (TKI) prolongs survival after first or second line therapy in patients with advanced NSCLC. Statistically significant and clinically relevant differences were observed for overall and progression free survival in favour of erlotinib. Moreover, several clinical factors had been correlated with response to gefitinib or erlotinib, including never smoking status, female gender, Asian ethnicity and adenocarcinoma histology (especially bronchioalveolar carcinoma).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
- •No previous therapy for advanced/metastatic NSCLC is allowed
- •age >18 years
- •bidimensionally measurable disease
- •non-smokers (or ex-smokers with less than 5 pack-years smoking history)
- •adenocarcinoma histology
- •performance status (WHO) 0-3
- •adequate liver (serum bilirubin <1.5 times the upper normal limit (UNL); AST and ALT <2.5 times the UNL in the absence of demonstrable liver metastases, or <5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
- •previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields
- •patient able to take oral medication
- •tissue sample for tumour mutational analysis is required
排除标准
- •serious chronic skin conditions (e.g. psoriasis, eczema) that would preclude study participation
- •active infection
- •history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- •malnutrition (loss of ≥ 20% of the original body weight)
- •performance status: 4
- •psychiatric illness or social situation that would preclude study compliance
- •pregnant or lactating women
研究组 & 干预措施
1
Tarceva
干预措施: Erlotinib (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
次要结局
- Overall Survival(1-year OS)
- Time to Tumor Progression(1 year TTP)
- Quality of life assessment(Assessment every two cycles)
- Toxicity assesment(Toxicity assessment on each cycles)