UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044863
Receipt number R000050892
Scientific Title Safety and efficacy of first-line Osimertinib therapy including the frequency of drug-induced lung disease
Date of disclosure of the study information 2021/07/19
Last modified on 2023/01/13 15:10:43

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Basic information

Public title

Safety and efficacy of first-line Osimertinib therapy including the frequency of drug-induced lung disease

Acronym

Safety and efficacy of first-line Osimertinib therapy including the frequency of drug-induced lung disease

Scientific Title

Safety and efficacy of first-line Osimertinib therapy including the frequency of drug-induced lung disease

Scientific Title:Acronym

Safety and efficacy of first-line Osimertinib therapy including the frequency of drug-induced lung disease

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the frequency of drug-induced lung disease in patients with advanced non-small cell lung cancer, EGFR mutation positive, and treated with Osimertinib as first-line therapy, based on retrospectively collected data.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the frequency of drug-induced lung disease

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients for whom information on medical treatment and prognosis can be obtained from medical records.
2.Patients with a confirmed diagnosis of non-small cell lung cancer and positive EGFR mutation who received Osimertinib as first-line therapy
3.Patients who are 20 years old or older.

Key exclusion criteria

1.Patients who have requested not to participate in this study based on the published information.
2.Patients who are currently participating or will participate in clinical research involving interventions related to pharmacotherapy.
3.Other patients who are judged ineligible by the principal investigator.

Target sample size

160


Research contact person

Name of lead principal investigator

1st name Motoko
Middle name
Last name Tachihara

Organization

Kobe University Graduates School of Medicine

Division name

Division of Respiratory Medicine/Department of Internal Medicine

Zip code

650-0017

Address

7-5-2 Kusunoki-cho, Chuou-ku, Kobe, Hyogo

TEL

078-382-5660

Email

mt0318@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Chihiro
Middle name
Last name Mimura

Organization

Kobe University Hospital

Division name

Division of Respiratory Medicine

Zip code

650-0017

Address

7-5-2 Kusunoki-cho, Chuou-ku, Kobe, Hyogo

TEL

078-382-5660

Homepage URL


Email

f9s5m1s3@gmail.com


Sponsor or person

Institute

Kobe University Graduates School of Medicine

Institute

Department

Personal name



Funding Source

Organization

No

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

KOBE University Hospital Clinical Translational Research Center

Address

7-5-2 Kusunoki-cho, Chuou-ku, Kobe, Hyogo

Tel

078-382-6669

Email

f9s5m1s3@gmail.com


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 07 Month 19 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

133

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

2021 Year 06 Month 01 Day

Date of IRB

2022 Year 01 Month 21 Day

Anticipated trial start date

2021 Year 07 Month 19 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The survey sheet will be sent to the facilities that are able to participate in this research study, and the research staff at each facility will enter the survey results, which will then be compiled at the data center.


Management information

Registered date

2021 Year 07 Month 14 Day

Last modified on

2023 Year 01 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050892


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name