A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment for Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 663
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) Time
研究概览
简要总结
This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care in NSCLC. Participants must have received 1 of 6 induction regimens for 4 cycles and did not have progressive disease prior to randomization (enrollment) into this trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologic or cytologic diagnosis of NSCLC Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or Stage IV prior to induction therapy.
- •Participants must have had 1 of the following induction therapies for treatment for Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV NSCLC: Gemcitabine plus carboplatin, paclitaxel plus carboplatin, or docetaxel plus carboplatin, gemcitabine plus cisplatin, paclitaxel plus cisplatin or docetaxel plus cisplatin.
- •Participants must have received only 1 chemotherapeutic doublet lasting precisely 4 cycles.
- •Induction regimens must be based on 21-day cycles.
- •Documented evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD). Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the participant to be randomized. Positron emission tomography (PET) scans and ultrasounds may not be used for lesion measurements for response determination.
排除标准
- •With the exception of those chemotherapies listed as inclusion criterion, participants will not be included if they have received prior systemic anticancer therapy (including adjuvant early-stage treatment for NSCLC) or any systemic treatment for any other cancer.
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •Inability to comply with protocol or study procedures.
- •A serious concomitant systemic disorder that 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.
研究组 & 干预措施
Pemetrexed and Best Supportive Care
干预措施: Pemetrexed (Drug)
Pemetrexed and Best Supportive Care
干预措施: Best Supportive Care (Other)
Placebo and Best Supportive Care
干预措施: Placebo (Drug)
Placebo and Best Supportive Care
干预措施: Best Supportive Care (Other)
结局指标
主要结局
Progression-Free Survival (PFS) Time
时间窗: Randomization to measured PD or death from any cause (up to 41 months)
PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant's last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
次要结局
- Time to Worsening of Symptoms (TWS)(Randomization to worsening of each LCSS item (up to 39 months))
- Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)(Baseline to measured PD (up to 41 months))
- Overall Survival (OS) Time(Randomization to date of death from any cause (up to 41 months))
- Number of Participants With Adverse Events (AEs)(Baseline to study completion (up to 41 Months))
- Time to Objective Progressive Disease (TPD)(Randomization to measured PD (up to 41 months))
- Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS(Baseline through 30 days post discontinuation of study treatment (up to 39 Months))