A Randomized Phase II Trial of Erlotinib or Intermittent Dosing of Erlotinib and Docetaxel in Male Former-smokers With Locally Advanced or Metastatic Squamous NSCLC in Second-line Setting After Failure on Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- Percentage of Participants Free From Disease Progression or Death at 6 Months
研究概览
简要总结
This randomized parallel group study will assess the efficacy and safety of erlotinib [Tarceva], as monotherapy or intermittent dosing with docetaxel, in second-line setting in former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4 cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally, days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •male patients, >/=18 years of age
- •former smoker (smoked >/= 100 cigarettes in his lifetime and quit >12 months before enrollment)
- •locally advanced (stage IIIb), metastatic (stage IV) or recurrent squamous non-small cell lung cancer
- •prior platinum-based therapy for advanced NSCLC
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
排除标准
- •uncontrolled symptomatic central nervous system (CNS) metastases
- •prior therapy against epidermal growth factor receptor (EGFR)
- •>1 prior chemotherapy for advanced/metastatic NSCLC
- •radiotherapy <28 days prior to enrollment
- •history of melanoma at any time, or another malignancy in the last 5 years except for carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or surgically cured malignant neoplasias with a disease-free interval of >5 years
- •not fully treated eye inflammation or infection, or predisposing conditions
研究组 & 干预措施
A
干预措施: erlotinib [Tarceva] (Drug)
B
干预措施: docetaxel (Drug)
B
干预措施: erlotinib [Tarceva] (Drug)
结局指标
主要结局
Percentage of Participants Free From Disease Progression or Death at 6 Months
时间窗: Month 6
According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, progressive Disease (PD) is defined as: for Target Lesions - At least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). (Note: the appearance of one or more new lesions is also considered progression). For Non-Target Lesions - Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).
次要结局
- Progression-free Survival (PFS)(From randomization until progressive disease or death, assessed up to 18 months)
- Overall Survival (OS)(From randomization until death, assessed up to 18 months)
- Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)(From randomization until progressive disease or death, assessed up to 18 months)
- Percentage of Participants With Disease Control(From randomization until progressive disease or death, assessed up to 18 months)
- Duration of Response (DoR)(From randomization until progressive disease or death, assessed up to 18 months)