BEPACT Lung: Impact of Patient Characteristics on Pneumo-oncologists Non Small Cell Lung Cancer (NSCLC) Systemic Treatment Decision in Belgium: A Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 21
- 主要终点
- The Study Outcome is Defined as the Systemic Treatment Choice.
研究概览
简要总结
The treatment landscape of metastatic non small cell lung cancer (NSCLC) is rapidly evolving. There are new diagnostic and treatment options available in the coming months and years.
New combination treatments will give different solutions to pneumo-oncologists who might be guided by certain patient and tumor characteristics.
The link between patient and tumor characteristics in untreated stage IV non small cell lung cancer (NSCLC) patients and systemic treatment needs further investigation, allowing the identification of possible treatment issues, data gaps and/or areas of improvement.
详细描述
This is a multicenter, non-interventional, cross-sectional study. Consecutive patients with metastatic stage IV non small cell lung cancer (NSCLC) selected for systemic treatment or best supportive care will be included in the trial at the time the patient signed the informed consent form (ICF). Patients that were selected for systemic treatment, should have received at least their first dose and a maximum of one cycle of the same treatment.
The pneumo-oncologist that treats the patient will fill in the CRF, indicating the systemic treatment option and the link with the variable categories that impacted the choice for a systemic treatment option.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have voluntarily agreed to participate by giving written informed consent/assent for the trial.
- •Have a histologically or cytologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) on first-line (1L) systemic treatment.
- •Have received at least their first dose of the selected systemic treatment and a maximum of 1 cycle of the same treatment. Patients that were selected to receive best supportive care will not have to comply to this inclusion criterion.
- •Be ≥ 18 years of age on day of signing informed consent.
排除标准
- •Has received prior systemic treatment for their metastatic non-small cell lung cancer (NSCLC) before the first dose of trial treatment. However, subjects who received adjuvant or neoadjuvant therapy during an earlier stage of their disease, but evolved to stage IV, are eligible.
- •Tyrosine kinase inhibitor (TKI) selected as first-line systemic treatment.
- •Is participating in an interventional trial or medical need program.
结局指标
主要结局
The Study Outcome is Defined as the Systemic Treatment Choice.
时间窗: during visits 1 and 2, up to approximately 3 weeks
Systemic treatment choices are defined as : 1. Chemotherapy (chemo) 2. Immunotherapy (IO) 3. immuno combined therapies (IO+IO) 4. IO+chemo 5. IO+bevacizumab+chemo (IO+bev+chemo) 6. best supportive care (BSC). There is no exposure in this study.
次要结局
未报告次要终点