NCT06232265招募中不适用
An Observational Study on Predicting the Efficacy of Immunotherapy for Non-small-cell Lung Cancer Based on LIRAscore
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a multi-center, observational clinical study to explore the role of LIRAscore in predicting immunotherapy monotherapy and combination with chemotherapy efficacy and prognosis in locally advanced or metastatic non-small-cell lung cancer. The study plans to enroll 108 patients. The primary endpoint of this study was ORR, and secondary endpoints were PFS, OS, DoR, DCR, and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily participated in the study, signed the informed consent, and had good compliance;
- •Histologically and/or cytologically confirmed previously untreated, locally advanced or metastatic non-small-cell lung cancer (stage IIIB/IIIC or stage IV) without driver gene mutation;
- •Patients are willing to receive immunotherapy monotherapy or immunotherapy combined with chemotherapy;
- •The patient agrees to provide the remaining tissue samples after clinical routine diagnosis during the baseline period for LIRA score and PD-L1 immunohistochemical testing;
- •The Eastern Organization for Oncology (ECOG) physical fitness score is 0 or 1;
- •The patient has at least one measurable or unmeasurable but evaluable lesion.
排除标准
- •According to clinical routine, patients do not meet the criteria for receiving standard anti-tumor treatment;
- •Patients with known EGFR mutations, ALK rearrangements or ROS1 rearrangements are not eligible to participate in this study;
- •According to the researcher's judgment, the patient is not suitable to participate in this study.
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 3 years
Defined as the proportion of patients who achieved complete response (CR) or partial response (PR)
次要结局
- Duration of response (DoR)(3 years)
- Disease Control Rate (DCR)(3 years)
- Progression-free Survival (PFS)(3 years)
- Overall Survival (OS)(3 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Prospective Observational Study to Predict the Response of Biliary Tract Tumors to ImmunotherapyBiliary Tract TumorCholangiocarcinomaNCT06048289Zhejiang Cancer Hospital150
已完成
不适用
Observational Study to Evaluate the Efficacy and Safety of TeneligliptinType 2 Diabetes MellitusNCT03793023Handok Inc.2,983
招募中
不适用
Observation on the Therapeutic Effect of Huaier Granules in the Adjuvant Treatment of Non-small Cell Lung Cancer After Radical SurgeryNon-small Cell Lung CancerNCT06109454Liaoning Tumor Hospital & Institute240
终止
不适用
Allogeneic Hematopoietic Cell Transplantation for Adult Acute Lymphoblastic Leukemia (2015)Precursor Cell Lymphoblastic Leukemia-LymphomaNCT02428517Asan Medical Center20
已完成
不适用
A Multicenter, Prospective, oBservational Study to assEss the Clinical activitY and Impact on symptOm Burden and patieNts' HRQoL of Treatment With trabecteDin in aSTS in a Real World Setting in GreeceAdvanced Soft Tissue SarcomaNCT02618122Genesis Pharma S.A.63