Post-marketing Clinical Trial of Induction Chemotherapy of Pemetrexed Plus Carboplatin Followed by Pemetrexed Maintenance Therapy for Advanced Nonsquamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods
研究概览
简要总结
To investigate efficacy and safety of the combination with pemetrexed plus carboplatin, followed by pemetrexed in patients with advanced nonsquamous Non Small Cell Lung Cancer (NSCLC) who receive at least one dose of the induction therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-squamous cell Non Small Cell Lung Cancer (NSCLC) disease
- •Clinical stage IIIB/IV or recurrent disease after surgery
- •No prior systemic chemotherapy, immunotherapy, targeted therapy or biological therapy, including adjuvant therapy
- •Prior radiation therapy is allowed to less than 25% of the bone marrow
- •Measurable disease as defined by response evaluation criteria in solid tumors (RECIST)
- •The Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Adequate organ function
- •Estimated life expectancy of at least 12 weeks
排除标准
- •Clinically significant third-space fluid collections
- •Central nervous system disease other than stable and treated brain metastasis
- •More than 3 weeks interval between the surgery and enrollment request date
- •Unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), for a 5 days period
- •Unable or unwilling to take folic acid or vitamin B12 supplementation
- •Unable to take corticosteroids.
- •Serious concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol
- •Currently have and historically had interstitial pneumonitis (interstitial pneumonia) or pulmonary fibrosis manifested as opacity on Chest x-ray or Computed tomography (CT)
研究组 & 干预措施
Pemetrexed + Carboplatin
After four 21-day cycles of Pemetrexed plus Carboplatin treatment, Pemetrexed monotherapy is continued until study discontinuation.
干预措施: Pemetrexed (Drug)
Pemetrexed + Carboplatin
After four 21-day cycles of Pemetrexed plus Carboplatin treatment, Pemetrexed monotherapy is continued until study discontinuation.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods
时间窗: Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months)
PFS defined as time from enrollment date to first date of objective progression of disease or of death from any cause. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy.
次要结局
- Overall Survival (OS) During the Induction and Maintenance Therapy Periods(Enrollment to the date of death from any cause (up to 30.8 months))
- Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods(Enrollment to date of progressive disease (up to 18 months))
- Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods(Enrollment to date of progressive disease (up to 18 months))
- Progression Free Survival (PFS) During the Maintenance Therapy Period(From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 24.4 months))
- Overall Survival (OS) During the Maintenance Therapy Period(From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 26.3 months))
- Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Maintenance Therapy Period(From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months))
- Percentage of Participants Who Observe a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction Therapy Period(Enrollment to the date of PD, or end of induction period up to Cycle 4 (21-day cycle))
- Percentage of Participants Who Achieve a Complete Response (CR) or a Partial Response (PR) During the Induction Therapy Period(Enrollment to date of PD, or end of induction period up to Cycle 4 (21-day cycle))