UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041251 |
|---|---|
| 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 | 2024/08/09 15:57:00 |
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Basic information
Public title
Retrospective observational study of osimertinib and afatinib for patients with advanced EGFR-mutated non-small cell lung cancer.
Acronym
Retrospective study of osimertinib and afatinib in EGFR-mutated NSCLC.
Scientific Title
Retrospective observational study of osimertinib and afatinib for patients with advanced EGFR-mutated non-small cell lung cancer.
Scientific Title:Acronym
Retrospective study of osimertinib and afatinib in EGFR-mutated NSCLC.
Region
| Japan |
Condition
Condition
Advanced non-small cell lung cancer harboring EGFR mutation.
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of osimertinib and afatinib for advanced non-small cell lung cancer harboring EGFR mutation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to Discontinuation of any EGFR tyrosine kinase inhibitor (TD-TKI)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Morise |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
466-8560
Address
65, Turumaicho, Showaku, Nagoya, Aichi, Japan
TEL
+81-052-741-2111
morisem@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Ito |
Organization
Matsusaka Municipal Hospital
Division name
Department of Respiratory Medicine, Respiratory Center
Zip code
515-0073
Address
1550, Tonomachi, Matsusaka City, Mie, Japan
TEL
+81-598-23-1515
Homepage URL
kentarou_i_0214@yahoo.co.jp
Sponsor or person
Institute
Central Japan Lung Study Group (CJLSG)
Institute
Department
Personal name
Funding Source
Organization
Central Japan Lung Study Group (CJLSG)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsusaka Municipal Hospital
Address
1550, Tonomachi, Matsusaka, Mie, Japan
Tel
+81-598-23-1515
kentarou_i_0214@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
Not available URL
Publication of results
Unpublished
Result
URL related to results and publications
https://www.esmoopen.com/article/S2059-7029(21)00073-9/fulltext
Number of participants that the trial has enrolled
557
Results
TD-TKI in the afatinib and osimertinib groups was 18.6 months and 20.5 months, respectively, without significant difference (P = 0.204). OS adjusted by propensity score favored the afatinib group with a significant difference (P = 0.018). Subgroup analysis with propensity score showed that patients with L858R and without brain metastasis had superior survival benefit with afatinib compared with osimertinib (P < 0.001).
Results date posted
| 2024 | Year | 08 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All consecutive NSCLC patients who were treated with osimertinib or afatinib as first-line therapy between May 2016 and October 2019 from 15 institutions in Japan.
Participant flow
Retrospectively registered
Adverse events
Not applicable
Outcome measures
Primary endpoint: TD-TKI, using propensity scoring analysis by the inverse probability of treatment weighting (IPTW) method.
Secondary endpoints: OS, PFS, and TTF.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 14 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 31 | Day |
Other
Other related information
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.
Management information
Registered date
| 2020 | Year | 07 | Month | 29 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047106
