A Randomized Phase 3 Study Comparing Pemetrexed-Carboplatin With Docetaxel-Carboplatin as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Survival Without Grade 3 or 4 Toxicity
研究概览
简要总结
The purpose of this study is to compare the combination of pemetrexed and carboplatin with the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4 toxicity in previously untreated patients with locally advanced or metastatic 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
- •Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior chemotherapy for advanced disease or molecular target treatment
- •Easter Cooperative Oncology Group (ECOG) performance status 0 to 2
- •Estimated life expectancy of at least 8 weeks
排除标准
- •Known or suspected brain metastases
- •Concurrent administration of any other tumor therapy
- •Serious concomitant disorders
- •Pregnancy or breast feeding
- •Inability or unwillingness to take folic acid or vitamin B12 supplementation
研究组 & 干预措施
pemetrexed plus carboplatin
Drug: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous (IV), every (q) 21 days x 6 cycles maximum
Drug: carboplatin Area Under the Curve (AUC) 5 milligram*minute/milliLiter (mg*min/mL), IV, q 21 days x 6 cycles maximum
干预措施: pemetrexed (Drug)
pemetrexed plus carboplatin
Drug: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous (IV), every (q) 21 days x 6 cycles maximum
Drug: carboplatin Area Under the Curve (AUC) 5 milligram*minute/milliLiter (mg*min/mL), IV, q 21 days x 6 cycles maximum
干预措施: carboplatin (Drug)
docetaxel plus carboplatin
Drug: docetaxel 75 mg/m^2, IV, q 21 days x 6 cycles maximum
Drug: carboplatin AUC 5 mg*min/mL, IV, q 21 days x 6 cycles maximum
干预措施: docetaxel (Drug)
docetaxel plus carboplatin
Drug: docetaxel 75 mg/m^2, IV, q 21 days x 6 cycles maximum
Drug: carboplatin AUC 5 mg*min/mL, IV, q 21 days x 6 cycles maximum
干预措施: carboplatin (Drug)
结局指标
主要结局
Survival Without Grade 3 or 4 Toxicity
时间窗: Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact.
次要结局
- Overall Survival (OS)(Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).)
- Progression-free Survival (PFS)(Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).)
- Percentage of Participants With Tumor Response (Response Rate)(Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).)
- Survival Without Clinically Important Grade 3 or 4 Toxicity(Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).)
- Survival Without Grade 4 Toxicity(Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months).)
- Number of Participants With Adverse Events (AEs)(Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).)