A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin in the First Line Therapy of Advanced NSCLC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate)
研究概览
简要总结
This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.
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
- •Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV
- •No previous systemic chemotherapy for this cancer
- •At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria In Solid Tumors (RECIST) criteria
- •Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 and adequate organ function
- •Prior radiation therapy allowed but limited to <25% of the patient's bone marrow
排除标准
- •Serious concomitant systemic disorder or active infection
- •Mild to moderate renal insufficiency, but unable to interrupt salicylates or other nonsteroidal anti-inflammatory drugs
- •Symptomatic central nervous system (CNS) metastases requiring concurrent corticosteroid therapy
- •Presence of clinically significant third-space fluid collections
研究组 & 干预措施
Pemetrexed + Cisplatin
干预措施: Pemetrexed (Drug)
Pemetrexed + Cisplatin
干预措施: Cisplatin (Drug)
Pemetrexed + Carboplatin
干预措施: Pemetrexed (Drug)
Pemetrexed + Carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate)
时间窗: Randomization to Month 6
For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 \* exp(-6 λ) \* (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln\[ r / ∑ti \] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,...,n), event or censored up to 6 months, and n= total number of patients per treatment group.
次要结局
- Overall Survival(Randomization to date of death from any cause (up to 1 year))
- Number of Participants With Tumor Response (as Basis for Response Rate)(Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression)
- Time to Treatment Failure (TTF)(Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year))
- Pharmacology Toxicities(Every 21-day cycle for up to 6 cycles)