A Randomized, Multicenter, Open-label Phase Ib/II Study of RO5083945 in Combination With Cisplatin and Gemcitabine/Pemetrexed Versus Cisplatin and Gemcitabine/Pemetrexed in Patients With Advanced or Recurrent Non Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA)
研究概览
简要总结
This open label, 2-part study will evaluate the safety and efficacy of RO5083945 in combination with standard chemotherapy in patients with advanced or recurrent non-small cell lung cancer who have not received prior chemotherapy. In Part 1 patients will receive RO5083945 intravenously and standard chemotherapy (cisplatin plus either gemcitabine or pemetrexed) for up to 6 cycles of 3 weeks and then RO5083945 until disease progression. In Part 2 patients will be randomized to receive either RO5083945 in combination with standard chemotherapy or chemotherapy alone for up to 6 cycles. In the absence of disease progression, patients receiving RO503945 can continue treatment with RO5083945 as monotherapy.
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
- •Adult patients, >/=18 years of age
- •Advanced (IIIb), metastatic (IV) or recurrent non-small cell lung cancer
- •At least 1 measurable disease lesion as per RECIST criteria
- •Confirmed presence of EGFR in tumor tissue
- •ECOG performance status 0-1
- •Adequate hematological, renal and liver function
排除标准
- •Prior chemotherapy or treatment with another systemic anti-cancer agent
- •Radiotherapy within the last 4 weeks, except for limited field palliative radiotherapy for bone pain relief
- •Symptomatic or active CNS metastases
- •Recent history of poorly controlled hypertension (systolic >180mmHg or diastolic >100mmHg)
- •Requirement for steroids > 40 mg prednisolone
研究组 & 干预措施
A non-squamous
干预措施: RO5083945 (Drug)
A non-squamous
干预措施: cisplatin (Drug)
A non-squamous
干预措施: pemetrexed (Drug)
A squamous
干预措施: RO5083945 (Drug)
A squamous
干预措施: cisplatin (Drug)
A squamous
干预措施: gemcitabine (Drug)
B non-squamous
干预措施: cisplatin (Drug)
B non-squamous
干预措施: pemetrexed (Drug)
B squamous
干预措施: cisplatin (Drug)
B squamous
干预措施: gemcitabine (Drug)
结局指标
主要结局
Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA)
时间窗: 6 months
Part 2: Progression-free survival, according to RECIST criteria by CT/MRI
时间窗: 23 months
次要结局
- Duration of response, according to RECIST criteria by CT/MRI(from response to disease progression)
- Pharmacokinetics of RO5083945 (AUC, Cmax and Cmin) in combination with cisplatin and gemcitabine/pemetrexed(multiple sampling cycles 1-6 (18 weeks))
- Overall survival(23 months)
- Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), according to RECIST criteria by CT/MRI(23 months)
- Overall response rate (ORR), according to RECIST criteria by CT/MRI(23 months)