A Randomized Ph 3 Study Comparing First-Line Pemetrexed/Cisplatin Followed by Gefitinib With Gefitinib Alone in East Asian Never Smoker or Light Ex-Smoker Patients With Locally Advanced or Metastatic Nonsquamous NSCLC
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to compare two different approaches to treating non-small cell lung cancer (NSCLC) in East Asian never-smoker participants. Half of the participants will receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti-cancer agent (gefitinib) and the other half of the participants will receive only the oral anti-cancer agent (gefitinib).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of NSCLC with locally advanced or metastatic disease that is of non-squamous histology.
- •Participants must be "light ex-smokers" or "never-smokers".
- •"Light ex-smokers" defined as having ceased smoking for greater than or equal to 5 years and not to have exceeded 10 pack-years.
- •"Never-smokers" are defined as having smoked <100 cigarettes or equivalent during his/her lifetime.
- •Participants must be of East Asian ethnicity.
- •No prior systemic therapy for lung cancer.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
- •Any evidence of clinically active interstitial lung disease. Asymptomatic participants with chronic, stable, radiographic changes are eligible.
- •Participants whose Epidermal Growth Factor Receptor (EGFR) mutation status is known prior to study entry will be excluded. Participants in which EGFR mutation testing has not been performed, or whose EGFR mutation status is unknown or inconclusive at study entry are eligible.
研究组 & 干预措施
Pemetrexed + Cisplatin + Gefitinib
干预措施: Pemetrexed (Drug)
Pemetrexed + Cisplatin + Gefitinib
干预措施: Cisplatin (Drug)
Pemetrexed + Cisplatin + Gefitinib
干预措施: Gefitinib (Drug)
Gefitinib
干预措施: Gefitinib (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Randomization to the first date of measured PD or death up to 37.32 months
PFS was defined as the time from date of randomization to the objective disease progression or death due to any cause. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Progressive disease (PD) was defined as 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 and/or unequivocal progression of existing nontarget lesions. Participants who did not have a complete baseline disease assessment were censored at the date of randomization, regardless if PD was objectively determined or if participant died or if a participant was not known to have died or have objective PD at the data inclusion cutoff date. PFS was censored at the last complete objective progression-free disease assessment date.
次要结局
- Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)](Randomization up to 37.52 months)
- Time to Progressive Disease (TtPD)(Randomization to the first date of measured PD up to 37.32 months)
- Overall Survival (OS)(Randomization up to date of death from any cause up to 57.13 months)
- Duration of Tumor Response(Date of initial response to the date of measured PD or death up to 34.43 months)
- Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)(Every cycle while on-study therapy and at 3 months post last dose)
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)](Randomization up to 37.52 months)