An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the Treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
研究概览
简要总结
The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nonsquamous Non-Small Cell Lung Cancer that was confirmed by tissue biopsy
- •Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2)
- •Tumor considered potentially resectable
- •Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale (ECOG)
- •No prior therapy for lung cancer
- •Measurable disease according to version 1.1 of Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
- •Life expectancy of at least 6 months
- •Organs are functioning well (bone marrow reserve, liver, kidney, lung)
- •Signed Informed Consent
- •Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after last dose of study drug; must have a negative pregnancy test within 7 days before study enrollment; and must not be breast-feeding.
- •Men must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after last dose of study drug.
- •Be fit for surgery at the time of enrollment
排除标准
- •Receiving or have received an investigational drug or device within the last 30 days
- •Have previously completed or withdrawn from this study or any other study investigating pemetrexed
- •Serious concomitant systemic disorder
- •Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
- •Receiving concurrent administration of any other anticancer therapy
- •Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination
- •Inability or unwillingness to take Pemetrexed supplementation/premedication (folic acid, vitamin B12, or corticosteroids)
- •Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day
研究组 & 干预措施
Pemetrexed + Cisplatin
干预措施: Pemetrexed (Drug)
Pemetrexed + Cisplatin
干预措施: Cisplatin (Drug)
Pemetrexed + Cisplatin
干预措施: Folic Acid (Drug)
Pemetrexed + Cisplatin
干预措施: Vitamin B12 (Drug)
Pemetrexed + Cisplatin
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
时间窗: From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size \[\<10 millimeter (mm) short axis\]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.
次要结局
- Percentage of Participants With No Viable Tumor Cells in Resected Lung Tissue [Pathological Complete Remission (pCR)](At the time of surgery (within 3 to 6 weeks of Day 1 of Cycle 3 [21-day cycles] of chemotherapy))
- Percentage of Participants Who Exhibit a Downward Shift in Tumor Extent From Stage IIIAN2 to Stages IIIA, II, I, or Stage 0(From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy)
- Overall Survival (OS)(Enrollment until the date of death from any cause up to 64 months)
- Progression-Free Survival (PFS)(Enrollment until the first date of objectively determined PD or death up to 64 months)