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临床试验/NCT03505515
NCT03505515已完成不适用

Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced/Metastatic Lung Cancer: a Retrospective Observational Study

Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 6,205 人开始时间: 2017年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6,205
试验地点
1
主要终点
Distribution of first-line treatment duration

研究概览

简要总结

The purpose of the study is to document real-world pattern of care, outcomes and health resource use for participants diagnosed with and receiving treatment for advanced Non-small cell lung cancer (NSCLC) and extensive disease Small cell lung cancer (SCLC) in China.

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

入选标准

  • Histologically confirmed advanced NSCLC (IIIB/IV) and extensive disease SCLC with pathology/cytology record between 1-Dec-2013 and 30-Nov-2014
  • Received inpatient treatment more than twice (inclusive) at a selected site. For hospitals with outpatient records, patients receiving oral TKI therapy and routinely (more than twice a year) followed up outpatient will be included although no inpatient records. For hospitals with outpatient chemotherapy center, patients will be include if they were prescribed with chemotherapy and routinely (more than twice a year, inclusive) followed up outpatient in the hospital
  • 18 years of age or older at initial diagnosis of IIIB/IV NSCLC and extensive disease SCLC

排除标准

  • Patients who have participated in or are attending clinical trials receiving active LC therapy
  • Unknown initial diagnosis time and initial treatment time.
  • For hospitals without outpatient chemo therapy center, patients who were prescribed with chemo therapy but with no inpatient records will be excluded
  • Patients who received inpatient therapy for one time and were not routinely (more than twice a year, inclusive) followed up outpatient will be excluded
  • Other protocol defined inclusion/exclusion criteria could apply

结局指标

主要结局

Distribution of first-line treatment duration

时间窗: Approximately 36 months

Calculated by the difference between the treatment start date of the first observed drug in the regimen and the last observed date of the regimen

Proportion of participants receiving fourth-line systemic therapy

时间窗: Approximately 36 months

Proportion of patients receiving fourth-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

Proportion of participants receiving first-line systemic therapy

时间窗: Approximately 36 months

Proportion of patients receiving first-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

Proportion of participants receiving second-line systemic therapy

时间窗: Approximately 36 months

Proportion of patients receiving second-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

Distribution of subsequent regimens

时间窗: Approximately 36 months

All chemotherapy, radiation and/or biologic drugs given to a patient following first-line regimen

Distribution of first-line therapy completion rate

时间窗: Approximately 36 months

Completion of more than 4 cycles

Distribution of subsequent therapy completion rate

时间窗: Approximately 36 months

Completion of more than 4 cycles

Proportion of participants receiving third-line systemic therapy

时间窗: Approximately 36 months

Proportion of patients receiving third-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

Distribution of first-line regimens

时间窗: Approximately 36 months

All chemotherapy, radiation and/or biologic drugs given to a patient during the first 28 days after initiation of treatment

Distribution of subsequent treatment duration

时间窗: Approximately 36 months

Calculated by the difference between the treatment start date of the first observed drug in the regimen and the last observed date of the regimen

次要结局

  • Distribution of disease characteristic data(At baseline)
  • Distribution of Overall Survival from first observed diagnosis to death(At baseline)
  • Distribution of other cancer-directed therapies(Approximately 36 months)
  • Distribution of Interval of Therapy(Up to 36 months)
  • Distribution of Lung Cancer related direct health care costs(Up to 36 months)
  • Distribution of Overall Survival from the initiation of third-line systemic anti-cancer therapy to death(At baseline)
  • Distribution of patient demographic data(At baseline)
  • Distribution of Overall Survival from the initiation of first-line systemic anti-cancer therapy to death(At baseline)
  • Distribution of Overall Survival from the initiation of second-line systemic anti-cancer therapy to death(At baseline)
  • Distribution of Overall Survival from the initiation of fourth-line systemic anti-cancer therapy to death(At baseline)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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