NGR014: Randomized Phase II Study of NGR-hTNF in Combination With Standard Chemotherapy Versus Standard Chemotherapy Alone in Previously Untreated Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 4
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The main objective of this study is to demonstrate superiority in progression-free survival (PFS) when NGR-hTNF is added to standard chemotherapy regimen (cisplatin/gemcitabine or cisplatin/pemetrexed) in locally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent non-small cell lung cancer (NSCLC).
详细描述
Eligible patients will be randomly assigned to a standard chemotherapy regimen plus low-dose (0.8 mcg/m^2) NGR-hTNF or standard chemotherapy alone, through a centralized randomization process using the following stratification factors: performance status (0 vs 1) and histology (squamous vs non-squamous). In both arms the choice between the two chemotherapy regimens will be based on the histologic subtype: in patients with squamous histology (including also generic diagnosis of NSCLC without further subtype classification) is recommended cisplatin/gemcitabine regimen, in patients with nonsquamous histology (including adenocarcinoma and large-cell carcinoma) is recommended cisplatin/pemetrexed regimen.
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
A: NGR-hTNF + cisplatin/gemcitabine or cisplatin/pemetrexed
NGR-hTNF with cisplatin/gemcitabine regimen in patients with squamous histology or with cisplatin/pemetrexed regimen in patients with nonsquamous histology
干预措施: NGR-hTNF (Drug)
A: NGR-hTNF + cisplatin/gemcitabine or cisplatin/pemetrexed
NGR-hTNF with cisplatin/gemcitabine regimen in patients with squamous histology or with cisplatin/pemetrexed regimen in patients with nonsquamous histology
干预措施: Cisplatin (Drug)
A: NGR-hTNF + cisplatin/gemcitabine or cisplatin/pemetrexed
NGR-hTNF with cisplatin/gemcitabine regimen in patients with squamous histology or with cisplatin/pemetrexed regimen in patients with nonsquamous histology
干预措施: Gemcitabine (Drug)
A: NGR-hTNF + cisplatin/gemcitabine or cisplatin/pemetrexed
NGR-hTNF with cisplatin/gemcitabine regimen in patients with squamous histology or with cisplatin/pemetrexed regimen in patients with nonsquamous histology
干预措施: Pemetrexed (Drug)
B: cisplatin/gemcitabine or cisplatin/pemetrexed
Cisplatin/gemcitabine regimen is administered in patients with squamous histology and cisplatin/pemetrexed regimen is administered in patients with nonsquamous histology
干预措施: Cisplatin (Drug)
B: cisplatin/gemcitabine or cisplatin/pemetrexed
Cisplatin/gemcitabine regimen is administered in patients with squamous histology and cisplatin/pemetrexed regimen is administered in patients with nonsquamous histology
干预措施: Gemcitabine (Drug)
B: cisplatin/gemcitabine or cisplatin/pemetrexed
Cisplatin/gemcitabine regimen is administered in patients with squamous histology and cisplatin/pemetrexed regimen is administered in patients with nonsquamous histology
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD
PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)
次要结局
- Objective response rate(Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD)
- Duration of response (DR)(from the time of first recorded evidence of complete response or partial response until the progressive disease objectively documented)
- Safety according to NCI-CTCAE criteria (version 3)(from the date of randomization until 28 days after last treatment)
- Overall survival (OS)(from the randomization until to the date of patient death or discontinuation from the study)