Study of Antitumor Immune Response Generated After Concurrent Chemo-radiotherapy (cCRT) and IO Treatment in Non-resectable Stage IIIA/B and IIIC NSCLC Patients Treated in Real World.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 22
- 主要终点
- Overall survival (OS)
研究概览
简要总结
Observational, multicenter, one-arm, non-comparative study. Data will be recorded in a retrospectively manner. The study will be based on secondary data collected from patient clinical chart completed by the doctor during routine visits. The primary objective is describe the antitumor immune response generated in the context of IO (immunotherapy) treatment after cCRT in patients with unresectable NSCLC treated in real world.
详细描述
The study is based on the collection of blood samples and tumor sample analysis, in real world NSCLC stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients on treatment with IO after cCRT without progression. The patients participating in this study will not receive treatment in relation to the study, no drugs will be provided. Patients will be treated as per standard clinical practice. All data collected for this study will be collected retrospectively from patient clinical chart. Only secondary data collected will be analyzed together will samples analysis information.The duration of the study is expected to be 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patients with histologically- or cytologically- documented NSCLC who present unresectable stage IIIA-IIIB-IIIC disease, according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology).
- •PDL1>1%.
- •Age ≥ 18 years at time of study
- •Patients without progression after cCRT, that are going to receive IO treatment (Durvalumab) for 12 months as subsequent treatment as per standard clinical practice
- •Patient capable of proper therapeutic compliance and accessible for correct follow-up.
- •Patients must have signed, dated and IRB/EC-approved written informed consent form in accordance with regulatory and institutional guidelines.
排除标准
- •Patients who refuse to sign and date an IRB/IEC-approved written informed consent form.
- •No possibility of venipuncture
- •Any medical, mental, or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.
研究组 & 干预措施
Observational Study Group
Real world non-small cell lung cancer (NSCLC) stage IIIA/B and IIIC; PD-L1>1%; non-resectable patients in treatment with IO after concurrent chemo-radiotherapy without progression.
干预措施: Durvalumab (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: To evaluate the Overall Survival at 12, 18, 24 and 36 months
Defined from the date of diagnosis to death from any cause. Patients alive at the end of follow-up or lost to follow-up are censored at the last contact time. The probability of remaining free of events at specific timepoints
Progression-free survival (PFS)
时间窗: To evaluate the Progression-free survival at 12, 18, 24 and 36 months
Defined from the diagnosis date to the date of investigator-determined disease relapse or death, whichever occurs first. The probability of remaining free of events at specific timepoints
次要结局
- Association between ctDNA clearance (no detection of ctDNA) after IO treatment and Progression free survival (PFS) or Overall survival (OS).(From date of end of treatment until the date of last follow up, assessed up to 36 months)