A Randomized, Double-blind, Placebo Controlled, Multicentre, Phase II Study of Oral Lapatinib in Combination With Concurrent Radiotherapy and Cisplatin Versus Radiotherapy and Cisplatin Alone, in Subjects With Stage III, IVA, B Squamous Cell Carcinoma of the Head and Neck (SCCHN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Number of Participants (Par.) With Complete Response (CR), as Assessed by Independent Radiological Review
研究概览
简要总结
This is a phase II study comparing the effects of lapatinib versus placebo when administered concurrently with cisplatin and radiotherapy followed by 1 year monotherapy with lapatinib or placebo. The study is designed to evaluate and compare the two treatment groups with respect to complete response rate at 6 months following chemoradiation completion.
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
- Double (Participant, Investigator)
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
Lapatinib
1500mg lapatinib orally daily
干预措施: Lapatinib oral tablets (Drug)
Lapatinib
1500mg lapatinib orally daily
干预措施: radiotherapy (Drug)
Lapatinib
1500mg lapatinib orally daily
干预措施: cisplatin chemotherapy (Drug)
Placebo
orally daily
干预措施: Lapatinib oral tablets (Drug)
Placebo
orally daily
干预措施: radiotherapy (Drug)
Placebo
orally daily
干预措施: cisplatin chemotherapy (Drug)
结局指标
主要结局
Number of Participants (Par.) With Complete Response (CR), as Assessed by Independent Radiological Review
时间窗: From the date of randomization until 6 months post chemoradiation treatment, assessed for a median time of 13 months
Participants with CR are defined as those who achieved a complete tumor response at 6 months after the completion of the chemoradiation treatment (CRT), as assessed by independent radiological review. Tumor response was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per RECIST, CR is defined as the disappearance of all target and non-target lesions. Data are based on Week 24 scans from participants receiving study treatment at that time and on those in follow-up.
次要结局
- Disease-specific Survival(From the date of randomization until the date of death due to disease, assessed after a median of 13 months of follow-up)
- Number of Participants With CR, as Assessed by the Investigator(From the date of randomization until 6 months post chemoradiation treatment, assessed after a median time of 13 months of follow-up)
- Overall Survival (OS)(From the date of randomization until the date of death due to any cause, assessed after a median of 30.9 months)
- Number of Participants Who Died Due to Progressive Disease(From the date of randomization until the date of death due to disease under study, assessed after a median of 30.9 months)
- Analysis of Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) From Tumor Samples(Screening)
- Number of Participants With Distant Recurrence of Initial Disease(From the date of randomization until the first occurrence of distant metastasis, assessed after a median of 30.9 months)
- Distant Relapse(From the date of randomization until the first occurrence of distant metastasis, assessed after a median of 30.9 months)
- Number of Participants With Overall Response (OR), as Assessed by the Investigator(From the date of randomization until 6 months post chemoradiation treatment, assessed for a median of 13 months)
- Progression-Free Survival (PFS), as Assessed by the Investigator(From the date of randomization until the date of disease progression or death due to any cause, assessed after a median of 22 months of follow-up)
- Plasma Proteome Analysis(From up to 28 days prior to the first dose of lapatinib/placebo start to 8 weeks after the first dose)
- Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3(From the date of randomization until 6 months post chemoradiation treatment, assessed for up to 24 weeks)
- Number of Participants With Loco-regional Recurrence of Initial Disease(From the date of randomization until progression in the T or N site or death due to any cause, assessed after a median of 30.9 months)
- Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha)(Up to 28 days prior to the date of the first dose of lapatinib/placebo start)
- Number of Participants Negative and Positive for Human Papilloma Virus (HPV) Infection, as Determined From Tumor Samples(Up to 28 days prior to the first dose of lapatinib/placebo)
- Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3)(From the date of randomization until 6 months post chemoradiation treatment, assessed for up to 24 weeks)
- Loco-regional Control(From the date of randomization until progression in the T or N site or death due to any cause, assessed after a median of 30.9 months)