LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 795
- 试验地点
- 190
- 主要终点
- Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1
研究概览
简要总结
This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Erlotinib
Patients receive erlotinib tablets once daily
干预措施: erlotinib (Drug)
Afatinib
Patients receive afatinib tablets once daily
干预措施: afatinib (Drug)
结局指标
主要结局
Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1
时间窗: First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).
Progression Free Survival (PFS) was defined as the time from randomization to disease progression (or death if the patient died before progression) by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Overall Survival(From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).)
- Number of Participants With Objective Response According to RECIST 1.1(First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).)
- Number of Participants With Disease Control According to RECIST 1.1(First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).)
- Tumour Shrinkage(First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).)
- Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire(From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).)
- Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.(From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).)
- Change in Score Over Time in Coughing,Dyspnoea and Pain(From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).)