A Multicenter, Randomized, Open-label, Phase III Trial to Assess Efficacy and Safety of Cetuximab When Given in Combination With Cisplatin Plus 5 Fluorouracil Versus Cisplatin Plus 5-fluorouracil Alone for the First-line Treatment of Chinese Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC)
研究概览
简要总结
This trial aimed to assess efficacy and safety of cetuximab when given in combination with chemotherapy compared with chemotherapy alone in Chinese participants with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment.
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
- •Histologically or cytologically confirmed diagnosis of SCCHN
- •Recurrent and/or metastatic SCCHN, not suitable for local-regional treatment
- •Presence of at least 1 measurable lesion according to RECIST Version 1.1
- •Signed written informed consent before any trial-related activities are carried out
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Other protocol-defined inclusion criteria could apply
排除标准
- •Prior systemic chemotherapy, except if given as part of multimodal treatment for locally advanced disease, that was completed within 6 months before randomization
- •Surgery (excluding prior biopsy for diagnosis) or irradiation within 4 weeks before trial entry
- •Previous treatment with monoclonal antibody or signal transduction inhibitors targeting epidermal growth factor receptor
- •Nasopharyngeal carcinoma
- •Known central nervous system metastasis and/or leptomeningeal disease
- •Medical or psychological condition that would not permit the participant to complete the trial or sign informed consent
- •Legal incapacity or limited legal capacity
- •Other protocol-defined exclusion criteria could apply
研究组 & 干预措施
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
干预措施: Cetuximab (Drug)
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
干预措施: Cisplatin/Carboplatin (Drug)
Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil
干预措施: 5-fluorouracil (Drug)
Cisplatin/Carboplatin + 5-Flurouracil
干预措施: Cisplatin/Carboplatin (Drug)
Cisplatin/Carboplatin + 5-Flurouracil
干预措施: 5-fluorouracil (Drug)
结局指标
主要结局
Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC)
时间窗: Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)
PFS time was defined as the time in months from the date of randomization until first observation of PD (based on imaging as assessed by IRC), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 millimeter. PFS was measured using Kaplan-Meier (KM) estimates.
次要结局
- Best Overall Response Rate (ORR)(Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days))
- Duration of Response (DOR)(Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days))
- Progression-free Survival (PFS) Time, as Assessed by the Investigator(Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days))
- Overall Survival (OS) Time(Time from date of randomization up to data cutoff (assessed up to 904 days))
- Disease Control Rate (DCR)(Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days))
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Emergent Adverse Events Leading to Death and AEs Leading to Discontinuation(Time from date of randomization up to data cutoff (assessed up to 904 days))