NCT01005680已完成3 期
A Randomized Phase 3 Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin as First-Line Treatment in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of two different chemotherapy types in the first line treatment of advanced Non-Small Cell Lung Cancer (NSCLC).
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
- •Present with histologically proven or cytological diagnosis of non-squamous non-small cell lung cancer (NSCLC) Stage IIIB or IV.
- •Participants must agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug.
- •Female participants must not be pregnant.
- •No prior systemic chemotherapy for lung cancer.
- •At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors.
- •Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or
- •Adequate organ function.
- •Prior radiation therapy allowed to <25% of the bone marrow.
- •Signed informed consent document on file.
- •Estimated life expectancy of greater than or equal to 12 weeks.
- •Participant compliance and geographic proximity that allow adequate follow up.
排除标准
- •Peripheral neuropathy of great than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade
- •Inability to comply with protocol or study procedures.
- •A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to complete the study.
- •A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
- •Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- •Documented brain metastases unless the participant has completed successful local therapy for central nervous system metastases and has not taken corticosteroids for at least 4 weeks before enrollment.
- •Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
- •Significant weight loss (that is, greater than or equal to 10%) over the previous 6 weeks before study entry.
- •Concurrent administration of any other anti-tumor therapy.
- •Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents, such as piroxicam).
- •Inability or unwillingness to take folic acid or vitamin B12 supplementation.
- •Inability to take corticosteroids.
- •Pregnant or breast-feeding.
- •Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
研究组 & 干预措施
Pemetrexed plus Cisplatin
Experimental
干预措施: Pemetrexed (Drug)
Pemetrexed plus Cisplatin
Experimental
干预措施: Cisplatin (Drug)
Gemcitabine plus Cisplatin
Active Comparator
干预措施: Gemcitabine (Drug)
Gemcitabine plus Cisplatin
Active Comparator
干预措施: Cisplatin (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Randomization to date of death from any cause up to 35.8 months post-randomization
OS was defined as the duration from date of randomization to date of death from any cause. Participants who were alive were censored at the date of last contact.
次要结局
- Time to Treatment Failure (TtTF)(Randomization until date of discontinuation of study treatment due to adverse events, PD, or death from any cause up to 6.3 months post-randomization)
- Tumor Response Rate(Randomization until date of objective PD or death from any cause up to 35.8 months post-randomization)
- Risk/Benefit Ratio(Randomization to date of death from any cause up to 35.8 months post-randomization)
- Progression Free Survival (PFS)(Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomization)
- Time to Progressive Disease (TtPD)(Randomization to first date of PD up to 23.7 months post-randomization)
- Duration of Response (DoR)(Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomization)
研究者
研究点 (1)
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