NCT03050437Unknown2 期
A Randomized, Open Label, Phase II Study Comparing Pemetrexed Plus Cisplatin Followed by Pemetrexed Until Progression Versus Pemetrexed Alone Until Progression in Non-small Cell Lung Cancer Patients Who Have Progressed on First Line Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
It has not been established whether platinum-based doublets is better than single agent chemotherapy in EGFR mutant NSCLC patients who failed first-line EGFR TKI.
In this prospective trial, the investigators try to evaluate whether the progression-free survival of pemetrexed/cisplatin (PC) regimen is longer than that of pemetrexed single(P) regimen in NSCLC patients who have progressed after first line treatment of EGFR-TKI.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed nonsquamous NSCLC with activating EGFR mutation (on exon 19 deletion or exon 21 L858R mutation)
- •Stage IIIb, IV or recurrent NSCLC (AJCC 7th criteria)
- •Age ≥ 20 years
- •ECOG performance status of 0 or 1
- •At least one measurable lesion by RECIST 1.1
- •Progression after first line treatment with EGFR TKIs for advanced NSCLC
- •Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery
- •At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy
- •Adequate renal function: estimated creatinine clearance ≥ 45 mL/min
- •Organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 3 UNL, in case of known hepatic metastasis, AST/ALT< 5 UNL
- •Written informed consent form
- •No other previous systemic chemotherapy
排除标准
- •Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
- •Patients with post-obstructive pneumonia or uncontrolled serious infection
- •Pregnant or nursing women (Women of reproductive potential have to agree to use an effective contraceptive method)
- •Uncontrolled symptomatic brain metastasis
- •Presence of third space fluid which cannot be controlled by drainage
- •Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer.
研究组 & 干预措施
Pem/Cis
Experimental
Pem/Cis IV every 3 weeks
干预措施: Cisplatin (Drug)
Pem/Cis
Experimental
Pem/Cis IV every 3 weeks
干预措施: Pemetrexed (Drug)
Pem alone
Active Comparator
Pem IV alone every 3 weeks
干预措施: Pemetrexed (Drug)
结局指标
主要结局
progression-free survival
时间窗: 2 years
次要结局
未报告次要终点
研究者
Myung-Ju Ahn
MD, PhD
Samsung Medical Center
研究点 (1)
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