NCT04894591已完成不适用
Jazz Emerge 402: Phase IV Observational Study to Collect Safety and Outcome Data in Real-World Setting in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Zepzelca
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 41
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
To assess the effectiveness and safety of Zepzelca in adult participants with extensive stage small cell lung cancer (SCLC) in real-world clinical practice.
详细描述
A phase IV, prospective, single arm, multi-center, observational study to collect safety and outcome data of Zepzelca in adult participants with extensive stage SCLC previously exposed to at least one line of treatment with platinum-based chemotherapy. Patients enrolled in the study will be encouraged to complete patient reported outcome (PRO) questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patient has initiated or will be receiving Zepzelca treatment in line with the local Zepzelca prescribing information.
- •Decision to initiate treatment with Zepzelca was made as per investigator's routine treatment practice prior to enrollment in the study.
- •Patient, or a legally acceptable representative, signed the informed consent before any study-related activities are undertaken.
- •Patients initiating Zepzelca treatment in second-line.
- •Patients who are sensitive to platinum-based chemotherapy with CTFI≥180 days. The CTFI is defined as the length of time from last platinum dose to time of relapse or disease progression.
- •Eastern Cooperative Oncology Group performance status (ECOG) ≤1
排除标准
- •Patients who discontinued a prior Zepzelca treatment due to adverse events.
- •Patient who received more than 2 cycles of Zepzelca treatment in their current treatment schedule.
- •Patient received treatment with any investigational agent within 30 days prior to first Zepzelca infusion or plans to use another investigational agent while receiving Zepzelca.
- •Known CNS involvement prior to Zepzelca treatment.
- •Patients who were treated with Zepzelca in later lines rather than in second-line treatment
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: up to 6 months after first infusion
次要结局
- Overall Survival (OS)(up to 6 months after first infusion)
- Progression-Free Survival (PFS)(up to 6 months after first infusion)
- Duration of Response (DoR)(up to 6 months after first infusion)
- Disease Control Rate (DCR)(up to 6 months after first infusion)
- Distribution of Treatment Patterns in Participants Measured by Number of Days in a Cycle, Dose Intensity, Number of Dose Reductions and Dose Delays, Number of Cycles Summarized by Number of Previous Lines of Therapy(up to 6 months after first infusion)
- Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)(up to 6 months after first infusion)
- Time to Response to Zepzelca(up to 6 months after first infusion)
- Participants Health-related Quality of Life (HRQOL) using Patient Reported Outcome (PRO) Questionnaires(up to 6 months after first infusion)
- Overall Survival (OS) in Other Subgroups of Interest(up to 6 months after first infusion)
- Progression-Free Survival (PFS) in Other Subgroups of Interest(up to 6 months after first infusion)
- Duration of Response (DoR) in Other Subgroups of Interest(up to 6 months after first infusion)
- Disease Control Rate (DCR) in Other Subgroups of Interest(up to 6 months after first infusion)
- Assessing Safety and Tolerability of Zepzelca by Assessing the Number of Participants with SAEs and AESI in Subgroups of Interest(up to 6 months after first infusion)
研究者
研究点 (41)
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