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临床试验/NCT04930133
NCT04930133Unknown不适用

Totality Outcome of Afatinib Sequential Treatment in Patients With EGFR Sensitizing Mutation-positive NSCLC in South Korea

Seoul St. Mary's Hospital1 个研究点 分布在 1 个国家目标入组 737 人开始时间: 2020年2月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
737
试验地点
1
主要终点
Total TOT

研究概览

简要总结

The T790M mutation is highly sensitive to osimertinib, which is approved in this setting following failure of gefitinib, erlotinib or afatinib. In contrast to first- and second-generation EGFR TKIs, no predominant resistance mechanism to first-line osimertinib has been clearly defined yet. The most common mechanisms of resistance were c-MET amplification only for 15% of patients and the emergence of the EGFR C797S mutation in 7%, while > 60% of patients were still with no identifiable mechanisms of resistance. As a result, targeted treatment options following first-line osimertinib failure remain limited. Thus, interest on sequential administration of EGFR TKIs in patients with EGFR mutation-positive NSCLC has been growing. So, here in this study, we intend to investigate treatment outcome (TOT) along with the several treatment options starting from the first line EGFR TKI treatment to various second line treatments including 3rd generation TKI and chemotherapy and others.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Age more than 18 years
  • Stage IIIB/IIIC/IV/IVA/IVB NSCLC patients treated with first-line afatinib for EGFR sensitizing mutations (Del19, L858R, G719X, S768I, or L861Q etc.)
  • Afatinib treatment was started 13 month prior to data collection date to reduce premature censoring of patients. Data cutoff date will be determined before data entry starts.

排除标准

  • Patients who received drug(s) other than afatinib (Giotrif®) as the first-line treatment
  • Patients who received drug(s) other than 3rd-generation EGFR TKI osimertinib as the second-line in "Cohort A'

研究组 & 干预措施

Cohort A

T790M+ patients sequentially treated with osimertinib in cohort A

干预措施: Gilotrif (Drug)

Cohort B

T790M- patients treated with chemotherapy or other treatments in cohort B

干预措施: Gilotrif (Drug)

Cohort C

patients with unknown mutation status in cohort C

干预措施: Gilotrif (Drug)

Cohort D

Cohort D included patients who were still ongoing with afatinib.

干预措施: Gilotrif (Drug)

结局指标

主要结局

Total TOT

时间窗: Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).

the time on treatment (total TOT) of EGFR M+ NSCLC patients treated with afatinib in the first-line (TOT-1) followed by second line treatments(TOT-2) including osimertinib, chemotherapy and other treatments.

次要结局

  • objective response rate (ORR-1 & ORR-2's)(Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).)
  • overall survival time(Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin Hyoung Kang

Division of Medical Oncology, Department of Internal Medicine

Seoul St. Mary's Hospital

研究点 (1)

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