Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer

Henan Cancer Hospital0 个研究点目标入组 500 人开始时间: 2022年9月21日最近更新: 2022年9月21日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Henan Cancer Hospital
入组人数: 500
主要终点: Objective Response Rate (ORR) in second-line treatment of patients with non-small cell lung cancer based on Camrelizumab regimen

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

To explore the effectiveness and safety of Camrelizumab based cross-line therapy for patients with advanced NSCLC in the real world

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

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

•Signed informed consent and volunteered to join the study
•Aged >=18 years
•Patients with stage IIIb, IV, or relapsed non-small cell lung cancer diagnosed cytologically or histopathologically as EGFR/ALK-
•Eastern Cooperative Oncology Group (ECOG) performance status 0-1
•At least one measurable lesion (according to RECIST 1.1)
•No prior systemic therapy for advanced/metastatic NSCLC
•contraception

排除标准

•Those who are allergic to drug treatment；
•Patients who were also treated with other immunodrugs or therapies；
•Patients who are participating in other intervention studies；
•Patients with other malignant tumors at the same time；
•Pregnant or lactating women；
•The investigator did not consider the patients eligible to participate in the study under any other circumstances.

结局指标

主要结局

Objective Response Rate (ORR) in second-line treatment of patients with non-small cell lung cancer based on Camrelizumab regimen

时间窗: Up to 12 months

CR+PR

次要结局

To evaluate the safety of Camrelizumab based first/second line therapy in patients with non-small cell lung cancer(Up to 12 months)
Evaluation of Progression Free survival (PFS) in patients with non-small cell lung cancer based on first-line/second-line treatment with Camrelizumab(Up to 36 months)
OS(Up to 12 months)
Evaluation of second progression-free survival (PFS2) in patients with non-small cell lung cancer based on Camrelizumab regimen(Up to 12 months)

研究者

发起方

Henan Cancer Hospital

申办方类型

Other Gov

责任方

Sponsor

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