Open-Label Study Evaluating the Safety and Effectiveness of Immunopheresis With the LW-02 Column Alone or in Combination With Paclitaxel or Atezolizumab in Removing Soluble Tumor Necrosis Factor Receptors to Treat Patients With Advanced, Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This pilot study aims to evaluate the short-term and long-term safety, tolerability, and effectiveness of immunopheresis with the LW-02 column in removal of sTNFRs from plasma of patients with advanced, refractory NSCLC and to detect a potential disease control signal when employed in combination with low dose chemotherapy (ie, paclitaxel), immunotherapy (ie, atezolizumab) in patients who already failed first-line therapy, or as monotherapy in patients who already have failed second-line therapy.
详细描述
This is an open-label, Phase 2a pilot study of Immunicom's LW-02 column- combined with low-dose chemotherapy or immunotherapy in patients who have failed first-line treatment or employed as monotherapy in patients who have failed second-line therapy-to evaluate the short-term and long-term safety, tolerability and effectiveness of these approaches in removing sTNF-Rs and the potential for disease control in advanced, refractory NSCLC patients. Along with LW-02 column immunopheresis, patients enrolled in Arm 1 will receive combination immunotherapy with atezolizumab and patients enrolled in Arm 2 also will receive combination chemotherapy with paclitaxel. Patients in Arm 3 will be treated with LW-02 column immunopheresis alone as a third-line treatment regimen, assuming the first-line treatment included a platinum salt. Following study qualification, patients will be assigned to the appropriate treatment. All patients may receive up to 48 LW-02 column-based immunopheresis treatments over a 16-week (4-month) period with up to 3 treatments per week). Importantly, each LW-02 immunopheresis treatment should last up to 3 hours and process, approximately, 2 times the patient's plasma volume (2PV).
Each patient assigned to the treatment with LW-02 column-based immunopheresis will require central vascular access for the procedure. In general, a cuffed, tunneled dual-lumen catheter will be inserted into a central vein and remain in situ throughout the 16-week treatment phase (or longer if additional treatment is clinically indicated). The catheter will be used to connect the inlet and return lines of the apheresis system to the patient. Immunopheresis treatments will be performed using the LW-02 column used inline with a centrifugal apheresis system that allows for secondary plasma processing system (eg, the Terumo BCT Spectra Optia Apheresis System® or alternate apheresis system). Proper anticoagulation of the centrifugal apheresis device is generally provided by utilizing acid citrate dextrose formula A (ACD-A).
Patients will be followed and clinically evaluated for two-years posttreatment. In Year 1, patients will be clinically evaluated at 3, 6, 9, and 12 months from the end-of-treatment (EOT) visit. In Year 2 quarterly (every 3 months) telephone contacts will be made to determine overall survival.
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
盲法说明
Open-label
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 16 weeks
Treatment-Emergent Adverse Events which will be analysed in study ill be: 1. Adverse Event (AE) 2. Serious Adverse Events (SAE) 3. Adverse Device Effect (ADE) 4. Serious Adverse Device Effect (SADE) Each of the Treatment-Emergent Adverse Events will be assessed for their seriousness, severity \[using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 v. 5.0\] and causality (relationship with the use of the investigated medical device).
Column performance effectiveness
时间窗: 16 weeks
Column efficiency and effectiveness in removal of sTNF-Rs from patient plasma without clinically-meaningful leaching of capture ligand (SC-TNF-α) - change in sTNF-R and TNF-α plasma levels from initiation to the end of each LW-02 column perfornance effectiveness will be assessed to measure over 30 minutes (sTNF-Rs) and over the duration (leaching) of each procedure, respectively: * Removal of soluble TNF receptor 1 (sTNF-R1) * Removal of soluble TNF receptor 2 (sTNF-R2) * Leaching of sc-TNF-α from the column
Incidence of Treatment-Emergent Adverse Events of special interest.
时间窗: 16 weeks
Incidence of Treatment-Emergent Adverse Events of special interest assessment will include: 1. tumor lysis syndrome and 2. systemic inflammatory response syndrome. These events may or may not be serious and they may or may not be considered related to study treatment. Regardless of relationship or severity, these events will be recorded if they start after the first application of study treatment and will be followed until resolution.
次要结局
- Muscle performance assessment with a hand grip test(16 weeks)
- Patient functioninig with Eastern Cooperative Oncology Group (ECOG)(16 weeks)
- Quality of life assessment with EQ-5D-5L scale(16 weeks)
- Quality of life assessment with EORTC-QLQ-C30 scale(16 weeks)
- Quality of life assessment with EORTC-QLQ-LC29 scale(16 weeks)
- Clinical endpoint - overall survival(16 weeks)
- Clinical endpoint - progression free survival(16 weeks)
- Clinical endpoint - disease control rate(16 weeks)
- Nutritional status assessment(16 weeks)
- Physical performance status assessment with 6 minute walk test (6MWT)(16 weeks)