Study of Anti-telomerase T CD4 Immunity in Metastatic Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 6
- 主要终点
- overall survival
研究概览
简要总结
Increasing evidence suggests that immune responses might be a determining factor in lung cancer tumor progression.
The impressive clinical responses obtained with immune checkpoint inhibitors (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune response is required for their efficacy and highlight the critical role of antitumor T cell immunity. Recent progress on the fields of tumor immunology underlines the critical role of CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.
In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the investigators group have previously described novel promiscuous peptides (referred as UCP:Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor antigen.
By using UCP-based immuno-assay, pre-existing UCP-specific Th1 responses have been detected in the blood of lung cancer patients (Telocap01). The frequency and magnitude of this response were inversely correlate to the disease stage. Furthermore, UCP-specific responses were significantly found in patients with low PD1+ and TIM3+ T cells.
Then in TeloCap02 study, UCP specific Th1 immune responses will be evaluated in lung cancer before and after treatment (chemotherapy, immunotherapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Histologically or cytologically confirmed NSCLC (Non Small Cell Lung Cancer) or SCLC (small cell lung cancer)
- •stade IIIb or metastatic
- •Patient candidate to a first-line therapy
- •Performance status 0, 1 or 2 on the ECOG scale
- •Written informed consent
排除标准
- •History of adjuvant chemotherapy for lung cancer treatment
- •Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
- •Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
- •Active autoimmune diseases, HIV, hepatitis C or B virus
- •Patients with any medical or psychiatric condition or disease,
- •Patients under guardianship, curatorship or under the protection of justice.
结局指标
主要结局
overall survival
时间窗: date of death from any cause (within 2 years after the initiation of the treatment)
time between the date of initiation of treatment and the date of death from any cause
次要结局
- UCP-specific Th1 responses measured by ELISPOT assay(up to 12 months)
- Progression free survival(date of first progression of the disease (within 2 years after the initiation of the treatment))
- quality of life related to health measured by EORTC-QLQC30 and LC13 questionaries.(from the inclusion to patient death, up to 2 years)