Targeted Natural Killer (NK) Cell Based Adoptive Immunotherapy for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) After Radiochemotherapy (RCT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Progress free survival
研究概览
简要总结
Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)
详细描述
Patients with non-small cell lung carcinoma (NSCLC) in stage III A and III B showing at least stable disease after RCTx will be enrolled into the clinical trial. The aim of the study is to show the efficacy of an adjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine). Patients will be randomized 1:1 either to the interventional study group to receive 4 cycles of autologous immunotherapy with activated NK cells or to the control group (BSC).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First diagnosis of histologically and/or cytologically proven and unresectable NSCLC with clinically stage III A and III B
- •Completion of radiochemotherapy no longer than 8 weeks ago
- •Progression free according to RECIST criteria at the first assessment after completion of RCTx
- •Confirmed presence of Hsp70 on patient´s tumors
- •ECOG Status(Appendices) ≤ 2
排除标准
- •Any severe heart disease or any severe concomitant disease (ECOG stage > 2)
- •NSCLC patients (stage IIIA/B) eligible for initial surgery with a confirmed consent of an interdisciplinary tumorboard
- •Patients that show ALK positivity or an activating mutation of the EGFR-TK domain
- •Patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology
- •Receipt of immunosuppressive drugs including high dose systemic corticosteroids within 3 weeks before study entry. Low dose corticosteroids as they are a common treatment option for patients suffering from COPD are not an exclusion criterium
结局指标
主要结局
Progress free survival
时间窗: follow up after randomization for at least 18 months
次要结局
- overall survival (OS)(follow up after randomization for at least 18 months)
- toxicity (AE and SAE)(follow up after randomization for at least 18 months)
- quality of life (QoLQ-30, LC-13)(follow up after randomization for at least 18 months)
- biological parameters (NK cell activation)(follow up after randomization for at least 18 months)