Retrospective Hospitals' Database Analysis to Evaluate Efficacy and Safety of Double Immunochemotherapy in First-Line Non-Small Cell Lung Cancer in Real Clinical Practice in Poland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
研究概览
简要总结
This study will review medical records from hospitals in Poland to describe the demographics and baseline clinical characteristics of adults with advanced non-small cell lung cancer who received first-line nivolumab plus ipilimumab with chemotherapy in routine care between 01 January 2023 and 31 December 2023. The study will also describe treatment patterns and clinical outcomes, associated with immunotherapy.
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
- •Adults aged 18 years or older
- •Prescribed first-line nivolumab plus ipilimumab plus chemotherapy for non-small cell lung cancer between 01 January 2023 and 31 December 2023 in the Polish Drug Program
- •Diagnosis of inoperable locally advanced or metastatic non-small cell lung cancer with programmed death-ligand 1 tumor proportion score <50%
- •Eastern Cooperative Oncology Group performance status 0 to 1
- •At least one measurable lesion or a countable number of non-measurable lesions
- •Absence of activating mutations in the epidermal growth factor receptor (EGFR) gene or rearrangements in the anaplastic lymphoma kinase (ALK) gene and ROS1 gene
- •Absence of comorbid conditions that were not adequately controlled with pharmacological therapy and that, in the opinion of the treating physician, could compromise the safe administration of the study treatment
- •Absence of active autoimmune disease, except type 1 diabetes, hypothyroidism, psoriasis, or vitiligo
- •Hematopoietic function allowing treatment according to the current Summary of Product Characteristics (SmPC)
- •Absence of contraindications to nivolumab or ipilimumab according to the SmPC
- •Treatment history and response available for chart abstraction from treatment initiation through death or study end in living patients
- •Participants with central nervous system metastases may be included if they had no neurological symptoms, had at least stable disease after local treatment, and did not require chronic immunosuppressive doses of glucocorticoids
排除标准
- •Participants will be excluded from analysis if any of the following criteria are met:
- •Confirmed disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, unless treatment was continued following local ablative therapy in cases of oligoprogression (including central nervous system lesions).
- •Clinically significant deterioration without radiological evidence of disease progression.
- •Unacceptable or life-threatening toxicity, including any toxicity requiring treatment discontinuation as per the product's SmPC.
- •Clinically relevant hypersensitivity to the study drug or its components.
- •Decline in performance status to Eastern Cooperative Oncology Group (ECOG) grade 3 or
- •Treatment interruption due to adverse events exceeding 12 weeks.
- •Significant deterioration in quality of life, as documented in medical records.
- •Withdrawal of consent for continued treatment or participation.
研究组 & 干预措施
Overall Study Population
Adults with inoperable locally advanced or metastatic non-small cell lung cancer with programmed death-ligand 1 (PD-L1) tumor proportion score <50% who were prescribed first-line nivolumab plus ipilimumab plus chemotherapy in the Polish Drug Program between 01 January 2023 and 31 December 2023 at participating hospitals in Poland.
干预措施: Nivolumab + Ipilimumab + Chemotherapy (Combination Product)
结局指标
主要结局
Overall Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
时间窗: Up to 26 months
Disease Control Rate (DCR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
时间窗: Up to 26 months
Progression-Free Survival (PFS)
时间窗: Up to 26 months
Time from first-line treatment to documented disease progression or death from any cause, whichever occurs first.
Duration of Response (DOR) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
时间窗: Up to 26 months
Second-line systemic anticancer treatment prescribed after progression/discontinuation of first-line therapy
时间窗: Up to 26 months
Third-line systemic anticancer treatment prescribed after progression/discontinuation of second-line therapy
时间窗: Up to 26 months
Overall Survival (OS)
时间窗: Up to 26 months
Time from initiation of first-line treatment to death from any cause.
Duration of Treatment
时间窗: Up to 26 months
Duration of first-line treatment, defined as the time from the first dose to the last dose recorded in the medical record.
次要结局
- Participant tumor burden assessed by the number of metastatic sites(Baseline)
- Number of Participants with Central Nervous System Metastases(Baseline)
- Number of Participants with Liver Metastases(Baseline)
- Participant Neutrophil-to-Lymphocyte Ratio as Assessed by Standard peripheral Blood Count Analysis(Baseline)