An Observational Study Describing Diagnosis and Treatment Patterns in Adults With Metastatic Non-small Cell Lung Cancer With BRAF V600E Mutation in Clinical Practice, to Assess Treatment Effectiveness and Quality of Life (OCTOPUS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 39
- 主要终点
- Description of treatment regiment/agents for first and second systemic treatment lines for mNSCLC
研究概览
简要总结
This study aims to describe the treatment patterns in clinical practice in adult patients with mNSCLC with a BRAF V600E mutation. This study will also describe Real-World Progression-Free Survival (rwPFS) and Overall Survival (OS) for treatments prescribed in routine practice for mNSCLC with BRAF V600E mutation. Adverse events (AEs) related to treatment management will also be described.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age ≥ 18 years at the time of first-line treatment initiation for mNSCLC,
- •Patients who initiated a first systemic treatment for mNSCLC in the metastatic setting from 01 December 2017 and before their study entry date (retrospectively enrolled patients), or Patients who initiated a first systemic treatment for mNSCLC (metastatic setting) at or after their study entry date (prospectively enrolled patients),
- •Confirmed diagnosis of Stage IV mNSCLCat any time before study inclusion Stage IV M1a, M1borM1c, as per the American Joint Committee on Cancer (AJCC cancer) staging manual,
- •Confirmed presence of BRAF V600E mutation - via tumor biopsy, metastasectomy, or liquid biopsy - at anytime before study inclusion,
- •Signed ICF or non-opposition to study participation,according to local regulations.
- •Patients eligible for prospective QoL data collection must, in addition to the above mentioned criteria, meet ALL of the following criteria to be eligible for the study:
- •Patients who initiate a first or second systemic treatment line for mNSCLC (metastatic setting) with a BRAF V600E mutation at or after their study entry date
排除标准
- •Concurrent or another previous malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, in-situcarcinoma of the cervix, Bowen's disease or Gleason ≤ 6 prostate cancer,
- •Previous, ongoing, or planned participation in a clinical trial involving an interventional drug as a first-or second-line systemic treatment for mNSCLC.
结局指标
主要结局
Description of treatment regiment/agents for first and second systemic treatment lines for mNSCLC
时间窗: From the start of first or second line treatment to progression or date of death from any cause,assessed up to 30 months
Names of regimens/agents
Time to treatment discontinuation
时间窗: From the start of first or second line treatment to the treatment discontinuation or death,assessed up to 30 months
Time to treatment discontinuation defined as the time between the date of start of a medication and the date of treatment discontinuation or death.
Description of line of treatment
时间窗: From the start of first or second line treatment to the end of second line treatment,assessed up to 30 months
Line of treatment number overall, not limited to metastatic setting
Description of duration of treatment line
时间窗: From the start of first or second line treatment to the end of line treatment,assessed up to 30 months
Duration of treatment line = End date of treatment line - Start date of treatment line
Time to next treatment
时间窗: From the start of first or second line treatment to the subsequent line treatment,assessed up to 30 months
Time to next treatment defined as the time between the date of start of a medication and the date of start of the next LoT.
次要结局
未报告次要终点