An Parallel Phase II Study of Tarceva (Erlotinib) in Patients With Advanced Non-small Cell Lung Cancer (Stage IIIB/IV) Not Pre-treated by Chemotherapy Including Dose Escalation to Toxicity in Current and Former Smokers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Non-Progression Rate (NPR) at 8 Weeks
研究概览
简要总结
This study will evaluate the efficacy and safety of Tarceva in two groups of patients with non-small cell lung cancer who have not been pre-treated with chemotherapy. One group, consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >=18 years of age;
- •histologically documented advanced non-small cell lung cancer (stage IIIB/IV);
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- •no previous chemotherapy.
排除标准
- •previous therapy which acts on Epidermal Growth Factor Receptor (EGFR) axis;
- •clinical evidence of brain metastasis;
- •any unstable systemic disease;
- •unable to take oral medication;
- •any significant ophthalmological abnormality.
研究组 & 干预措施
Never Smokers
Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
干预措施: erlotinib [Tarceva] (Drug)
Current/Former Smokers
Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
干预措施: erlotinib [Tarceva] (Drug)
结局指标
主要结局
Non-Progression Rate (NPR) at 8 Weeks
时间窗: Week 8
Non-Progressive Rate (NPR) was defined as the percentage of participants without progression (had stable disease (SD) or better) based on (Response Evaluation Criteria in Solid Tumours (RECIST) criteria 8 weeks after start of treatment. Diagnosis of Progressive Disease (PD) was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
次要结局
- Progression-Free Survival(Up to 2 years)
- Overall Survival(Up to 2 years)
- Disease Control Rate(Up to 2 years)
- Duration of Response(Up to 2 years)
- Time to Progression(Up to 2 years)
- Objective Response Rate(Up to 2 years)
- Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)(Up to 2 years)