Open-Label, Single Arm, Phase 3b Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory DLL3 Expressing Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 60
- 主要终点
- Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE
研究概览
简要总结
A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell lung cancer by evaluating the frequency of high grade (>= Grade 3) select treatment-emergent adverse events (TEAEs).
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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Minimum life expectancy of at least 12 weeks.
- •Laboratory values meeting the criteria specified in the protocol.
- •Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with documented disease progression after at least 2 prior systemic regimens, including at least one platinum-based regimen.
- •Delta-Like Protein 3 (DLL3)-expressing SCLC based on central immunohistochemistry (IHC) assessment of banked or otherwise representative tumor tissue.
- •Measurable disease as described per protocol.
- •In participants with a history of central nervous system (CNS) metastases, documentation of stable or improved status based on brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of study drug, off or on a stable dose of corticosteroids.
排除标准
- •Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III - IV within 6 months prior to first dose of study drug.
- •Recent or on-going serious infection.
- •History of other invasive malignancy that has not been in remission for at least 3 years.
- •History of exposure to a pyrrolobenzodiazepine (PBD)-based drug or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation.
- •Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.
- •Documented history of capillary leak syndrome.
- •Grade 2 or higher pleural or pericardial effusion within 4 weeks of investigational drug start, or earlier history of recurrent Grade 2 or higher effusions with ongoing requirements for pericardiocentesis or thoracentesis.
研究组 & 干预措施
Rovalpituzumab tesirine + dexamethasone
Rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle plus oral dexamethasone 8 mg twice daily on Day -1, Day 1, and Day 2 of 6-week each cycle.
干预措施: Dexamethasone (Drug)
Rovalpituzumab tesirine + dexamethasone
Rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle plus oral dexamethasone 8 mg twice daily on Day -1, Day 1, and Day 2 of 6-week each cycle.
干预措施: Rovalpituzumab tesirine (Drug)
结局指标
主要结局
Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE
时间窗: Approximately 32 months
Number of participants with a high grade (≥ Grade 3) protocol specified Treatment-Emergent Adverse Events (TEAEs) during and after treatment with rovalpituzumab tesirine. Severity of TEAEs will be graded at each study visit according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.
次要结局
- Change in Participant Reported Outcome EORTC QLQC15-PAL(Approximately 32 months)
- Progression Free Survival (PFS)(Approximately 32 months)
- Change in EORTC QLQ-LC-13(Approximately 32 months)
- Clinical Benefit Rate (CBR)(Approximately 32 months)
- Objective response rate (ORR)(Approximately 32 months)
- Duration of Objective Response (DOR)(Approximately 32 months)
- Overall Survival (OS)(Approximately 32 months)