An Expanded Access Program of Tarceva (Erlotinib) in Patients With Advanced Stage IIIB/IV Non-Small Cell Lung Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6,586
- 主要终点
- Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.
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
- •Adults greater than or equal to (≥) 18 years of age
- •Histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent NSCLC
- •Previous treatment with no more than 2 prior chemotherapy regimens
排除标准
- •Previous systemic anti-cancer therapy with human epidermal growth factor receptor 1 (HER1)/epidermal growth factor receptor (EGFR) inhibitors
- •Inability to take oral medication
- •Any other malignancies within 5 years
研究组 & 干预措施
Erlotinib
Erlotinib will be given as a single agent in this expanded access program (EAP) to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Treatment will continue until unacceptable toxicity, disease progression, or withdrawal for any other reason.
干预措施: Erlotinib (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
Objective response was defined as a best overall response of either complete response (CR) or partial response (PR) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. The percentage of participants (in nearest integer) with objective response was reported.
次要结局
- Percentage of Participants With Disease Control According to RECIST(Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter)
- Percentage of Participants by Best Overall Response According to RECIST(Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter)
- Progression-Free Survival (PFS) According to RECIST(Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter)
- Percentage of Participants Who Died(Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter)
- Percentage of Participants With Death or Disease Progression According to RECIST(Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter)
- Overall Survival (OS)(Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter)