A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (Metmab) in Combination With Paclitaxel + Cisplatin or Carboplatin as First-Line Treatment for Patients With Stage IIIb (T4 Disease) or IV Squamous Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 主要终点
- Progression-free survival (tumor assessments according to RECIST criteria)
研究概览
简要总结
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.
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
- •Adult patients, >/= 18 years of age
- •Histologically or cytologically confirmed Stage III B or Stage IV squamous non-small cell lung cancer (NSCLC)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •No prior chemotherapy for squamous NSCLC
- •Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
- •Radiographic evidence of disease
排除标准
- •Prior systemic treatment for Stage IIIB or IV squamous NSCLC
- •NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)
- •Prior exposure to experimental treatment targeting either the HGF or Met pathway
- •Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator
- •Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1
- •History of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer
- •Pregnant or lactating women
- •Uncontrolled diabetes
- •Impaired bone marrow, liver or renal function as defined by protocol
- •Significant history of cardiovascular disease
- •Positive for HIV infection
研究组 & 干预措施
MetMAb+paclitaxel+platinum
干预措施: cisplatin/carboplatin (Drug)
MetMAb+paclitaxel+platinum
干预措施: onartuzumab (Drug)
MetMAb+paclitaxel+platinum
干预措施: paclitaxel (Drug)
Placebo+paclitaxel+platinum
干预措施: Placebo (Drug)
Placebo+paclitaxel+platinum
干预措施: cisplatin/carboplatin (Drug)
Placebo+paclitaxel+platinum
干预措施: paclitaxel (Drug)
结局指标
主要结局
Progression-free survival (tumor assessments according to RECIST criteria)
时间窗: up to approximately 32 months
Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC
时间窗: up to approximately 32 months
次要结局
- Overall survival(up to approximately 32 months)
- Overall response rate (tumor assessments according to RECIST criteria)(up to approximately 32 months)
- Duration of response (time from first documented objective response to disease progression)(up to approximately 32 months)
- Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks)(up to approximately 32 months)
- Serum levels of anti-therapeutic antibodies (MetMAb ATAs)(Pre-dose Day 1 of Cycles 1, 2 and 4)
- Safety: Incidence of adverse events(up to approximately 32 months)
- Pharmacokinetics: serum concentration (Cmin/Cmax)(Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years)
- Plasma concentrations of paclitaxel/platinum(Pre- and post-dose on Day 1 of Cycles 1 and 4)