An Observational Study of Effectiveness and Safety of the First-Line Nivolumab Plus Ipilimumab With or Without Chemotherapy for Advanced/Recurrent Non-Small Cell Lung Cancer in Japan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 525
- 试验地点
- 2
- 主要终点
- Treatment continuation rate
研究概览
简要总结
The purpose of this observational study is to assess the effectiveness and safety of Nivolumab plus Ipilimumab with or without chemotherapy as first-line treatment for participants with untreated advanced or recurrent NSCLC in the real world setting in Japan.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- •Inclusion Criteria:
- •Histologically confirmed advanced or recurrent NSCLC
- •Participants who have received or scheduled to administrate nivolumab plus ipilimumab with or without chemotherapy as first-line treatment from the date of approval of nivolumab plus ipilimumab with or without chemotherapy to November 30,
- •Pemetrexed plus cisplatin or carboplatin for participants with non- squamous histology and paclitaxel plus carboplatin for participants with squamous histology are only acceptable combinations of chemotherapy.
排除标准
- •In participants with non-squamous histology, participants who are confirmed to be positive for EGFR gene mutation or ALK fusion gene for which EGFR tyrosine kinase inhibitor or ALK tyrosine kinase inhibitor is indicated.
- •Participants who had antineoplastic treatment as first-line treatment of advanced or recurrent NSCLC prior to initiation of nivolumab plus ipilimumab with or without chemotherapy.
- •However, participants who correspond to a) or b) below will be included in this study.
- •Prior perioperative chemotherapy or Stage III chemoradiotherapy or durvalumab combination chemoradiotherapy.
- •Participants who are received or have received bisphosphonates or denosumab for bone metastasis
- •Participants who initiated treatment with nivolumab plus ipilimumab and added chemotherapy from the second course onwards.
- •Participants who received investigational anti-tumor drug in clinical trial after being diagnosed with NSCLC
- •Other participants who are judged by the investigators to be inappropriate for enrollment in this study
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Treatment continuation rate
时间窗: Up to 1 year
The rate of eligible participants who have continued nivolumab plus ipilimumab with or without chemotherapy during the observation period.
Incidence of treatment-related adverse events (TRAEs) leading to treatment discontinuation
时间窗: Up to 1 year
Incidence of Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 Grade 3 or higher immune-related adverse events [irAEs]
时间窗: Up to 1 year
Time to next treatment [(TNT)
时间窗: Up to 1 year
Defined as the time between the date of combination therapy with nivolumab plus ipilimumab with or without chemotherapy initiation among eligible participants and the date of second-line treatment initiation or the date of death from any cause, whichever occurs first.
Overall survival (OS)
时间窗: Up to 1 year
Defined as the time between the date of initiation of nivolumab plus ipilimumab with or without chemotherapy and the date of death from any cause among eligible participants.
Treatment-free survival (TFS)
时间窗: Up to 1 year
Defined as the time between the date of nivolumab plus ipilimumab with or without chemotherapy cessation among eligible participants and the date of second-line treatment initiation or the date of death from any cause, whichever occurs first.
Rates of participants with second-line treatment
时间窗: Up to 1 year
The rate of eligible participants who have completed nivolumab plus ipilimumab with or without chemotherapy during the observation period and have initiated second-line treatment
Duration of treatment
时间窗: Up to 1 year
Time from the initiation date of nivolumab plus ipilimumab with or without chemotherapy among eligible participants to the last date of treatment as an event.
次要结局
- Duration of treatment of second-line treatment(Up to 1 year)
- Treatment related death of second-line treatment(Up to 1 year)
- Treatment-free survival in participants who discontinued treatment due to treatment-related adverse events within 90 days(Up to 1 year)
- Objective response rate (ORR) in participants evaluated for tumor response according to RECIST v 1.1(Up to 1 year)
- Disease control rate (DCR) in participants evaluated for response in accordance with RECIST v 1.1(Up to 1 year)
- Duration of response (DOR) in participants evaluated for tumor response in accordance with RECIST v 1.1(Up to 1 year)
- Incidence of CTCAE v 5.0 Grade 3 or higher irAEs by patient background(Up to 1 year)
- Incidence of TRAEs leading to treatment discontinuation by patient background(Up to 1 year)
- Treatment continuation rate of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors(Up to 1 year)
- Reasons for treatment discontinuation of second-line treatment(Up to 1 year)
- Treatment continuation rate in participants who discontinued treatment due to treatment-related adverse events within 90 days(Up to 1 year)
- Overall survival of second-line treatment in participants with disease progression within 90 days(Up to 1 year)
- Response rate of second-line treatment in participants with disease progression within 90 days(Up to 1 year)
- Progression-free survival (PFS) in participants assessed for tumor response according to RECIST v 1.1(Up to 1 year)
- Treatment-free survival (TFS) by patient background(Up to 1 year)
- Overall survival of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors(Up to 1 year)
- Response rate of second-line treatment(Up to 1 year)
- Treatment related death of second-line treatment in participants with disease progression within 90 days(Up to 1 year)
- Overall Survival (OS) by patient background(Up to 1 year)
- Time to next treatment (TNT) by patient background(Up to 1 year)
- Time to next treatment of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors(Up to 1 year)
- Time to onset of immune-related adverse events (irAEs) to be collected, treatment for these events and time to symptom improvement, and impact on effectiveness(Up to 1 year)
- Reasons for treatment discontinuation of second-line treatment in participants with disease progression within 90 days(Up to 1 year)
- Treatment continuation rate by patient background(Up to 1 year)
- Treatment-free survival of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors(Up to 1 year)
- Incidence of CTCAE v 5.0 Grade 3 or higher irAEs of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors(Up to 1 year)
- Incidence of TRAEs leading to treatment discontinuation of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors(Up to 1 year)
- Overall survival in participants who discontinued treatment due to treatment-related adverse events within 90 days(Up to 1 year)
- Time to next treatment in participants who discontinued treatment due to treatment-related adverse events within 90 days(Up to 1 year)
- Duration of treatment of second-line treatment in participants with disease progression within 90 days(Up to 1 year)