A Randomized Phase II Study of S1 Plus Carboplatin Followed by Maintenance S1versus Pemetrexed Plus Carboplatin Followed by Maintenance Pemetrexed in Patients With EGFR Wild Type Stage IIIB or IV Nonsquamous Non-Small-Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 470
- 试验地点
- 1
- 主要终点
- Progression free survival(PFS)
研究概览
简要总结
This study compared the efficacy and safety of S1 plus carboplatin (C) followed by S1 with pemetrexed plus carboplatin (C) followed by pemetrexed in patients with epidermal growth factor receptor (EGFR) wild type advanced nonsquamous non-small-cell lung cancer (NSCLC).Patients with previously untreated EGFR wild type stage IIIB or IV nonsquamous NSCLC and Eastern Cooperative Oncology Group performance status of 0 to 1 were randomly assigned to receive pemetrexed 500 mg/m2 or S1（80-120 mg/d）combined with carboplatin area under the curve (AUC) 5 every 3 weeks for up to four cycles. Eligible patients received maintenance until disease progression: pemetrexed or S1. The primary end point of this non-inferiority study was progression free survival（PFS）
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chemotherapy-naive patients with histologically or cytologically confirmed nonsquamous NSCLC, classified as stage IIIB not amenable to curative treatment or stage IV; EGFR wild type.
- •At least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •18 <age<75 years
- •Patients had adequate bone marrow reserve and organ function.
- •Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment and patients had fully recovered from its acute effects
- •Written informed consent was obtained directly from every patient
- •Estimated life expectancy of at least 12 weeks.
- •Patient compliance and geographic proximity that allow adequate follow up.
- •Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate during and for 3 months after the study. Women with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
排除标准
- •Brain metastasis associated with central nervous symptoms (patients were eligible if symptoms were controlled by steroids or other treatments);
- •Serious infections or other serious complications.
- •Uncontrolled third-space fluid retention before study entry. unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids
- •Have a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
- •Pregnant or breast feeding.
- •A distinct history of drug allergies
研究组 & 干预措施
S1 and Carboplatin
S1 80-120 mg/d+Carboplatin AUC=5 Patients without progression received maintenance until disease progression with S1
干预措施: S1 80-120 mg/d (Drug)
S1 and Carboplatin
S1 80-120 mg/d+Carboplatin AUC=5 Patients without progression received maintenance until disease progression with S1
干预措施: carboplatin AUC=5 (Drug)
pemetrexed and Carboplatin
pemetrexed 500 mg/m2+ Carboplatin AUC=5 Patients without progression received maintenance until disease progression with pemetrexed
干预措施: pemetrexed 500 mg/m2 (Drug)
pemetrexed and Carboplatin
pemetrexed 500 mg/m2+ Carboplatin AUC=5 Patients without progression received maintenance until disease progression with pemetrexed
干预措施: carboplatin AUC=5 (Drug)
结局指标
主要结局
Progression free survival(PFS)
时间窗: 3 years
次要结局
- Overall survival(OS)(4 years)
- Disease control rate(DCR)(3 years)
- Health-related quality of life(3 years)
- Number of Participants with Adverse Events(3 years)
研究者
Li Zhang
Professor
Sun Yat-sen University