UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042961
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email khamada@jp.imshealth.com

Sponsor
Institute IQVIA Solutions Japan K.K.,Real World Evidence Solutions/HEOR
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


Contact us.