A Phase III Randomized, Open-Label Clinical Trial of BBI-608 Plus Weekly Paclitaxel Versus Weekly Paclitaxel Alone in Patients With Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 主要终点
- Overall Survival
研究概览
简要总结
This is an international, multi-center, prospective, randomized, open-label Phase 3 clinical trial of the cancer stemness inhibitor napabucasin administered with weekly paclitaxel versus weekly paclitaxel alone in patients with advanced non-squamous non-small cell lung cancer who have disease progression following systemic treatment with a platinum-based combination regimen in the metastatic setting, who have received treatment with an immune checkpoint inhibitor if a candidate, additional approved therapies, and for whom weekly paclitaxel is an acceptable treatment option.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Must have histologically or cytologically confirmed non-squamous NSCLC.
- •Must have progressed following treatment with platinum-based combination chemotherapy for metastatic disease, and patients with an EGFR or ALK/ROS1 genetic aberration must have received appropriately targeted treatment.
- •Must have received either nivolumab or pembrolizumab or a different IND-approved anti-PD1 or anti-PD-L1 therapy, unless medically contraindicated
- •Weekly paclitaxel must be an acceptable treatment option
- •Must submit tumor tissue for correlative analyses
- •Women of child-bearing potential and partners of women of child-bearing potential must take measures to avoid pregnancy while receiving and for a period of time following protocol therapy
- •Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, adequate organ function, and a life expectancy of ≥ 3 months
排除标准
- •Has squamous NSCLC
- •Has received prior systemic treatment with a taxane for advanced/metastatic disease
- •Has received systemic anti-cancer therapy within the 14 days prior to randomization
- •Has received radiotherapy within the 28 days prior to randomization, with the exception of palliative radiotherapy to focal lesions for pain or other symptom control
- •Has brain metastases with evolving neurologic symptoms or a steroid requirement.
- •Has had major surgery requiring general anesthesia and/or mechanical ventilation within the 28 days prior to randomization
- •Has a corrected QT interval (QTc) > 470 ms or has an electrocardiogram (ECG) with a new abnormal finding that is clinically significant
- •Has peripheral neuropathy ≥ Grade 2 (NCI-CTCAE)
- •Refuses to complete quality of life questionnaires either alone or with assistance from study staff despite adequate fluency
- •Has an intercurrent (non-malignant) chronic medical or psychiatric illness or condition(s) not optimally controlled and carrying a moderate to high risk of interfering with protocol therapy administration or compliance with required procedures, in the judgment of the investigator
研究组 & 干预措施
Napabucasin plus Weekly Paclitaxel
Patients randomized to this arm will receive napabucasin administered orally, twice daily in combination with paclitaxel administered intravenously, once weekly, on 3 of every 4 weeks.
干预措施: Napabucasin (Drug)
Napabucasin plus Weekly Paclitaxel
Patients randomized to this arm will receive napabucasin administered orally, twice daily in combination with paclitaxel administered intravenously, once weekly, on 3 of every 4 weeks.
干预措施: Paclitaxel (Drug)
Weekly Paclitaxel
Patients randomized to this arm will receive weekly paclitaxel alone administered intravenously, once weekly, on 3 of every 4 weeks.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Overall Survival
时间窗: 36 months
To assess the effect of napabucasin plus weekly paclitaxel versus weekly paclitaxel on the Overall Survival of patients with previously treated advanced, non-squamous non-small cell lung cancer.
次要结局
- Overall Survival in Biomarker Positive Patients(36 months)
- Progression Free Survival in Biomarker Positive Patients(36 months)
- Progression Free Survival(36 months)
- Disease Control Rate(36 months)
- Disease Control Rate in Biomarker Positive Patients(36 months)
- Quality of Life (QoL)(36 months)
- Number of Patients With Adverse Events(36 months)