Unique ID issued by UMIN | UMIN000041251 |
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Receipt number | R000047106 |
Scientific Title | Retrospective observational study of osimertinib and afatinib for patients with advanced EGFR-mutated non-small cell lung cancer. |
Date of disclosure of the study information | 2020/07/30 |
Last modified on | 2020/07/29 18:21:50 |
Retrospective observational study of osimertinib and afatinib for patients with advanced EGFR-mutated non-small cell lung cancer.
Retrospective study of osimertinib and afatinib in EGFR-mutated NSCLC.
Retrospective observational study of osimertinib and afatinib for patients with advanced EGFR-mutated non-small cell lung cancer.
Retrospective study of osimertinib and afatinib in EGFR-mutated NSCLC.
Japan |
Advanced non-small cell lung cancer harboring EGFR mutation.
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To evaluate the efficacy and safety of osimertinib and afatinib for advanced non-small cell lung cancer harboring EGFR mutation.
Safety,Efficacy
Time to Discontinuation of any EGFR tyrosine kinase inhibitor (TD-TKI)
Observational
Not applicable |
Not applicable |
Male and Female
1. Diagnosed pathologically with non-small cell lung cancer.
2. With EGFR mutation, regardless of subtype of mutation.
3. Recieved afatinib or osimertinib as systemic first-line monotherapy.
1. Not recieved afatinib or osimertinib as a monotherapy.
2. Recieved chemotherapy or immunotherapy before monotherapy of afatinib/osimertinib as systemic treatment for advanced non-small cell lung cancer.
3. Cases identified as ineligible by investigator.
300
1st name | Masahiro |
Middle name | |
Last name | Morise |
Nagoya University Graduate School of Medicine
Department of Respiratory Medicine
466-8560
65, Turumaicho, Showaku, Nagoya, Aichi, Japan
+81-052-741-2111
morisem@med.nagoya-u.ac.jp
1st name | Kentaro |
Middle name | |
Last name | Ito |
Matsusaka Municipal Hospital
Department of Respiratory Medicine, Respiratory Center
515-0073
1550, Tonomachi, Matsusaka City, Mie, Japan
+81-598-23-1515
kentarou_i_0214@yahoo.co.jp
Central Japan Lung Study Group (CJLSG)
Central Japan Lung Study Group (CJLSG)
Other
Matsusaka Municipal Hospital
1550, Tonomachi, Matsusaka, Mie, Japan
+81-598-23-1515
kentarou_i_0214@yahoo.co.jp
NO
2020 | Year | 07 | Month | 30 | Day |
Unpublished
557
No longer recruiting
2019 | Year | 11 | Month | 12 | Day |
2019 | Year | 12 | Month | 16 | Day |
2020 | Year | 02 | Month | 20 | Day |
2020 | Year | 07 | Month | 31 | Day |
2020 | Year | 07 | Month | 31 | Day |
2020 | Year | 08 | Month | 14 | Day |
2021 | Year | 01 | Month | 31 | Day |
Study design: Multicenter, retrospective observational cohort study
Data cut-off in survival analysis: 31 Dec 2019 in the survival analysis.
Revision History of the study protocol:
2019.11.12 version 1.0
2020. 1.13 version 1.1
2020. 1.20 version 1.2
2020. 3.18 version 1.3
*The case enrollment period was extended to July 31, 2020, by the memorandum after version 1.3 of the protocol.
2020 | Year | 07 | Month | 29 | Day |
2020 | Year | 07 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047106
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