UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042961 |
|---|---|
| Receipt number | R000048663 |
| Scientific Title | Prospective Cohort of Advanced and Metastatic Non-Small Cell Lung Cancer Patients with EGFR Mutations: Long-Term Survival and Other Outcomes After First Line Osimertinib |
| Date of disclosure of the study information | 2021/01/11 |
| Last modified on | 2021/01/10 09:44:06 |
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Basic information
Public title
Prospective Cohort of Advanced and Metastatic Non-Small Cell Lung Cancer Patients with EGFR Mutations: Long-Term Survival and Other Outcomes After First Line Osimertinib
Acronym
1L Osimertinib Prospective Cohort Study
Scientific Title
Prospective Cohort of Advanced and Metastatic Non-Small Cell Lung Cancer Patients with EGFR Mutations: Long-Term Survival and Other Outcomes After First Line Osimertinib
Scientific Title:Acronym
1L Osimertinib Prospective Cohort Study
Region
| Japan |
Condition
Condition
Non-small Cell Lung Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
In stage IIIB/IV patients with NSCLC EGFRm treated with first line osimertinib in the real world
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To describe overall survival (OS) .
To describe progression-free survival (PFS).
To describe treatments and sequencing after treatment on first line osimertinib.
Key secondary outcomes
To describe baseline demographic and clinical characteristics: histology, disease stage at diagnosis, EGFR mutation, brain metastases, smoking status, age, gender, performance status etc.
To examine the association between baseline characteristics and OS, PFS.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with Stage IIIB-IV NSCLC with EGFR mutation
2)Age 20 or older at the time of advanced NSCLC diagnosis (specific age may vary according to country-specific guidelines)
3)Treated in the first line with osimertinib between August 2018 and December 2020, according to the label
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Eric |
| Middle name | |
| Last name | Yu |
Organization
IQVIA Solutions Japan K.K.
Division name
Real World Evidence Solutions/HEOR
Zip code
108-0074
Address
Takanawa 4-10-18, Minatoku, Tokyo
TEL
+81-80-3553-5352
EYu@jp.imshealth.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Hamada |
Organization
IQVIA Solutions Japan K.K.
Division name
Real World Evidence Solutions/HEOR
Zip code
108-0074
Address
Takanawa 4-10-18, Minatoku, Tokyo
TEL
+81-80-4591-3561
Homepage URL
khamada@jp.imshealth.com
Sponsor or person
Institute
IQVIA Solutions Japan K.K.,Real World Evidence Solutions/HEOR
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca(global)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-751-3830
ekim@kuhp.kyoto-u.ac.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
| 2021 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is non-interventional observation study using medical records. Patient past record will be also collected.
Management information
Registered date
| 2021 | Year | 01 | Month | 10 | Day |
Last modified on
| 2021 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048663
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
