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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028989
Receipt No. R000033169
Scientific Title Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer
Date of disclosure of the study information 2017/09/10
Last modified on 2020/09/07

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Basic information
Public title Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer
Acronym Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer
Scientific Title Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer
Scientific Title:Acronym Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer
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 1) To reveal the real world utilization of the key drugs such as 1st generation of EGFR-TKI, 2nd generation of EGFR-TKI, Osimertinib, immune checkpoint inhibitors (ICIs), and platinum doublets in the patients with EGFR mutation-positive advanced/recurrent non-Sq NSCLC, and search the best treatment sequence of these drugs.
2) Genetic analysis of the mechanisms of responsiveness and acquired resistance to Osimertinib.
Basic objectives2 Others
Basic objectives -Others Data cllection of real world treatments
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes To reveal real world clinical utility of Osimertinib in EGFR-mutant non-Sq NSCLC
1)Frequency of Osimertinib utilization after 1st or 2nd generation EGFR-TKI
2)Line of Osimertinib administration
3)Efficacy of Osimertinib
4)Toxicities of Osimertinib
Key secondary outcomes 1)To reveal real world treatments and their results for EGFR-mutant non-Sq NSCLC
2)To reveal the factors contributing to OS prolongation
3)Osimertinib-related part:
1.Frequency and success rate of re-biopsy
2.Efficacy of Osimertinib in CNS
3.Pattern, frequency, and severity of interstitial pneumonitis (IP) by Osimertinib
4)Osimertinib-unrelated part
1.Line of Nivolumab (and the other ICI monotherapy) administration
2.Response rate, disease control rate, and PFS of Nivolumab (and the other ICI monotherapy) in EGFR-mutated NSCLC
3.Accumulation and analysis of the cases who received an EGFR-TKI after ICIs.
5)To reveal interactions among different treatments especially that with ICI

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 I. Patients with histologically or cytologically confirmed EGFR mutation-positive advanced/recurrent non-Sq NSCLC (including minor mutation)
II. Patients who received or are planning to receive any drug therapy for NSCLC after 01 June 2016.
(Data are collected from the patients who actually received drug therapy after 01 June 2016.)
III. Sufficient functions of the main organs
IV. PS 0-2 at the start of initial drug therapy
Key exclusion criteria Patients judged by the investigator to be unsuitable for the study
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Fumio
Middle name
Last name Imamura
Organization Osaka International Cancer Institute
Division name Department of Thoracic Oncology
Zip code 5418567
Address 3-1-69 Otemae, Chuo-ku, Osaka 541-8567
TEL +81-6-6945-1181
Email imamura-fu@mc.pref.osaka.jp

Public contact
Name of contact person
1st name Fumio
Middle name
Last name Imamura
Organization Osaka International Cancer Institute
Division name Department of Thoracic Oncology
Zip code 5418567
Address 3-1-69 Otemae, Chuo-ku, Osaka 541-8567
TEL +81-6-6945-1181
Homepage URL
Email imamura-fu@mc.pref.osaka.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization AstraZeneca
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 Osaka International Cancer Institute
Address -1-69 Otemae, Chuo-ku, Osaka 541-8567
Tel +81669721181
Email imamura-fu@mc.pref.osaka.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
2017 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 524
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 Completed
Date of protocol fixation
2017 Year 09 Month 10 Day
Date of IRB
2017 Year 09 Month 27 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No

Management information
Registered date
2017 Year 09 Month 04 Day
Last modified on
2020 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033169

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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