Biomarkers Impact on the Response to Treatment With Erlotinib in First Line Non-small Cell Lung Cancer With EGFR Activating Mutations - BIOTEC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 9
- 主要终点
- Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
研究概览
简要总结
This open-label, single-arm, multi-center study will evaluate the progression-free survival in participants with histologically documented, advanced and/or metastatic chemotherapy naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) positive mutations and receiving erlotinib treatment. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
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
- •Histological documented adenocarcinoma, locally advanced - Stage IIIB, metastatic - Stage IV or recurrent non-squamous NSCLC
- •Activated EGFR mutation positive status (Exons 19 and 21) for treatment phase
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Life expectancy greater than or equal to (≥) 12 weeks
- •Evidence of disease with at least one measurable disease evaluation on Response Evaluation Criteria in Solid Tumors (RECIST)
- •Adequate hematological , liver and renal function
排除标准
- •Known hypersensitivity to erlotinib or any of its excipients
- •Squamous non-small cell or small cell tumors or absence of histological report
- •Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment
- •Prior exposure to inhibitors of EGFR
- •Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of disease
- •Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
- •Radical radiotherapy with curative intent within 28 days prior to enrollment
- •Any active non-controlled systemic disease
研究组 & 干预措施
Erlotinib
Participants will receive 150 milligrams (mg) erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
干预措施: Erlotinib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
时间窗: Baseline up to approximately 4 years
PFS was the time from inclusion in the study to the date of first documented PD or death from any cause, whichever occurred first. Participants without event were censored at the date of the last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Analysis was performed using Kaplan-Meier method. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
次要结局
- Number of EGFR Positive Participants Classified Based on Type of EGFR Mutations(Day 1)
- Percentage of Participants With Complete Response (CR) And Partial Response (PR) as Assessed by the Investigator Using RECIST v1.1(Baseline up to approximately 4 years)
- Number of EGFR Positive Participants Classified Based on Smoking Status(Day 1)
- Percentage of Participants by Localization of PD, as Assessed by Investigator Using RECIST v1.1(Baseline up to approximately 4 years)
- Percentage of Similar EGFR Mutations Between Matched Plasma and Tumor Tissue Samples(Baseline up to approximately 4 years)
- Time to Disease Progression, as Assessed by Investigator Using RECIST v1.1(Baseline up to approximately 4 years)
- Percentage of Participants Who Were Alive One Year After Study Treatment Initiation(Year 1)