jRCT1031240063招募中不适用
"Real world treatment practice, effectiveness, and safety of nivolumab combination with chemotherapy as a neoadjuvant therapy for resectable NSCLC patients in Japan, an observational study" (NivoLuminate)
ONO PHAMACEUTICAL CO., LTD.0 个研究点目标入组 200 人开始时间: 2024年7月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 主要终点
- Real world treatment practice
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients aged 18 years or older.
- •Patients diagnosed with resectable non-small cell lung cancer.
- •Patients who started or were planned to start nivolumab combined with chemotherapy as a neoadjuvant therapy * between April 1, 2023, and September 30,
- •Acceptable concomitant chemotherapies are cisplatin (or carboplatin) plus gemcitabine and carboplatin plus paclitaxel for squamous cell carcinoma, and cisplatin (or carboplatin) plus pemetrexed and carboplatin plus paclitaxel for non-squamous cell carcinoma.
- •(For those patients who were visiting the participating medical institutions) Patients who provided written consent with their own free will and full understanding, after receiving sufficient explanation regarding enrollment in the study,
- •(For those who have been transferred to another hospital) Patients who provided written or verbal consent with their own free will and full understanding, after receiving sufficient explanation regarding enrollment in this study. In cases where consent was obtained verbally, the verbal consent will be recorded in the medical records. Subsequently, for cases where written consent was obtainable, written consent will be obtained.
- •In addition, the following conditions are acceptable:
- •a) In the case of patients with difficulty in writing, enrollment for this study is permitted through the use of a scribe by an individual equivalent to a legally authorized representative, based on the patient's verbal consent.
- •b) For patients who are unable to provide consent themselves or who have died, enrollment through a legally authorized representative is permitted when written consent is obtained after explanation to the representative.
- •c) For patients who have died and it is difficult to obtain written consent from a legally authorized representative or the equivalent, enrollment through only research institutions that fall under the "Academic research institutions " as defined in Article 16, Paragraph 8 of the Act on the Protection of Personal Information is permitted when the reason for the difficulty in obtaining consent is recorded in the medical records, the research content is disclosed to the legally authorized representative or the equivalent, and they have the opportunity to refuse the implementation or continuation of the research through an opt-out method, in which case enrollment in this study is permitted.
排除标准
- •Patients with a positive EGFR mutation or ALK fusion gene confirmed prior to initiation of nivolumab combination with chemotherapy as a neoadjuvant therapy
- •Patients who have participated in a trial for antitumor effects in NSCLC and who have received a therapeutic agent
- •Patients who have received antitumor medication within 3 months before the initiation of nivolumab combined chemotherapy as a neoadjuvant therapy (however, those are receiving hormonal therapy are allowed for enrollment)
- •Patients with a complication of treatment-related adverse events of hematologic toxicity due to treatment with antitumor agents that had occurred more than 3 months before initiation of nivolumab combined with chemotherapy as a neoadjuvant therapy
- •Patients who started nivolumab combined with chemotherapy as a neoadjuvant therapy outside the participating medical institutions and were transferred to the participating medical institutions
- •Patients who are considered inappropriate for enrollment in the study, which was judged by the principal investigator or investigations at participating medical institutions
结局指标
主要结局
Real world treatment practice
Patients characteristics Treatment status Cancellation rate of surgery in patients treated with nivolumab combined with chemotherapy as a neoadjuvant therapy
Safety
时间窗: from the start of nivolumab combined with chemotherapy as a neoadjuvant therapy to within 100 days after the last dose
Treatment-related adverse events from the start of nivolumab combined with chemotherapy as a neoadjuvant therapy to within 100 days after the last dose; TRAE incidence Immune-mediated adverse events from the start of nivolumab combined with chemotherapy as a neoadjuvant therapy to within 100 days after the last dose; IMAE incidence
Effectiveness
Pathological complete response rate (pCR rate). Event-free survival (EFS) Overall Survival (OS)
次要结局
- Treatment status in patients where surgery was postponed
- Treatment status in patients with recurrence
- Treatment status in patients where surgery was cancelled
- Aggregation of the above treatment status items by patient characteristics
- Incidence of adverse events within 100 days after the last dose of nivolumab combined with chemotherapy as a neoadjuvant therapy(100 days after the last dose)
- Incidence of adverse events leading to cancellation of surgery
- Incidence of adverse events leading to delay of surgery
- Aggregation of the above safety items by patient characteristics
- Other aggregations required for safety evaluation
- Time to death or distant metastases (TTDM)
- Overall response rate (ORR)
- Pathological evaluation in the primary lesion
- Aggregation of the above efficacy items by patient characteristics
- Other aggregations required for efficacy evaluation
- Operative procedure
- Completeness of resection
- Incidence of surgery-related adverse events within 90 days of surgery(90 days of surgery)
- Treatment status
- Aggregation of the above treatment status by patient characteristics
- Treatment status of the subsequent therapies
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