Real-World Demographics, Clinical Characteristics and Outcomes in Resected Non-Small Cell Lung Cancer Patients Receiving Immunotherapy in Europe and Canada
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of participants with pathological complete response after neoadjuvant immunotherapy and surgical resection.
研究概览
简要总结
This study uses existing medical records to better understand how immunotherapy is used in people in Europe and Canada with non-small cell lung cancer (NSCLC) who undergo surgery. It looks at participant characteristics, treatments received before and after surgery, and outcomes such as survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Diagnosed with non-small-cell lung cancer (NSCLC) stage IIA to IIIB
- •Participants aged ≥18 years at time of NSCLC diagnosis
- •Initiated and received neoadjuvant nivolumab or neoadjuvant phase of perioperative immunotherapy during the patient inclusion period
- •Documented record of curative surgical resection following receipt of neoadjuvant nivolumab or neoadjuvant phase of perioperative immunotherapy
- •NSCLC is assessed as resectable by a clinician, surgeon, or multidisciplinary team.
排除标准
- •Diagnosis of another primary malignancy (excluding non-melanoma skin cancer) within 5 years prior to NSCLC diagnosis or at any time after diagnosis
结局指标
主要结局
Number of participants with pathological complete response after neoadjuvant immunotherapy and surgical resection.
时间窗: Up to 14 months
Pathological complete response (pCR) is defined as 0% residual viable tumor cells in the primary tumor and all sampled regional lymph nodes following neoadjuvant immunotherapy and surgical resection.
Number of participants with major pathological response after neoadjuvant immunotherapy and surgical resection.
时间窗: Up to 14 months
Major pathological response (MPR) is defined as ≤10% residual viable tumor cells in the primary tumor and all sampled regional lymph nodes following neoadjuvant immunotherapy and surgical resection.
Number of participants with post-operative complications following surgical resection
时间窗: Up to 90 days
Post-operative complications include infection, pneumonia, respiratory failure requiring assisted ventilation or intubation, immune-related pneumonitis, myocardial infarction, atrial fibrillation, cardiac failure, unplanned intensive care unit admission, stroke, acute renal failure, bronchopleural fistula, empyema, re-operation, prolonged hospitalization, prolonged air leak greater than 5 days, in-hospital death, 30-day death, and 90-day death.
Number of participants by surgical resection margin status
时间窗: Up to 14 months
Surgical resection margin status following surgery will be categorized as R0 (no residual tumor), R1 (microscopic residual tumor), or R2 (macroscopic residual tumor).
Number of participants by surgical resection type
时间窗: Day 1
Surgical resection type will be categorized as lobectomy, bilobectomy, segmentectomy, wedge resection, pneumonectomy, or sleeve resection.
Number of participants by surgical approach
时间窗: Day 1
Surgical approach will be categorized as open thoracotomy, video-assisted thoracoscopic surgery (VATS), or robotic-assisted surgery.
Number of participants with all-cause mortality within 90 days after surgery
时间窗: Up to 90 days
All-cause mortality occurring during hospitalization or within 90 days after surgical resection will be summarized.
次要结局
- Overall survival from surgical resection(Up to 46 months)
- Event-free survival from surgical resection(Up to 46 months)
- Number of participants initiating adjuvant immunotherapy after surgery(Up to 14 months)
- Time (days) from surgery to initiation of adjuvant immunotherapy(Up to 14 months)
- Number of participants receiving post-surgical systemic and local therapies(Up to 46 months)
- Length of hospital stay (days) following surgical resection(Up to 90 days)
- Number of participants with immune-mediated adverse events (AEs) during neoadjuvant immunotherapy(Up to 22 months)