UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective observational study of investigating the real world data of post-treatment after drug-induced lung injury by osimertinib and the safety and efficacy of EGFR-TKI re-challenge
Acronym	Osi-risk study
Scientific Title	A retrospective observational study of investigating the real world data of post-treatment after drug-induced lung injury by osimertinib and the safety and efficacy of EGFR-TKI re-challenge
Scientific Title:Acronym	Osi-risk study
Region	Japan

Condition
Condition	Non small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of EGFR-TKI rechallenge after second or later line therapy in non-small cell lung cancer patients who have previously suffered drug-induced lung injury due to Osimertinib administration in first-line therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cumulative incidence of drug-induced lung injury at 3, 6, and 12 months after initiation of EGFR-TKI rechallenge
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	Non small cell lung cancer patients who received Osimertinib as first-line therapy and who experienced clinical drug-induced lung injury
Key exclusion criteria	Patients participating in studies aimed at similar analysis of treatment after Osimertinib
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Hisao Middle name Last name Imai
Organization	Saitama Medical University International Medical Center
Division name	Respiratory Medicine
Zip code	350-1298
Address	1397-1, Yamane, Hidaka-City, Saitama-Pref, Japan
TEL	042-984-4177
Email	hisao725@saitama-med.ac.jp

Public contact
Name of contact person	1st name Naoya Middle name Last name Nishioka
Organization	Shizuoka cancer center
Division name	Thoracic Oncology
Zip code	411-8777
Address	1007, Shimo-nagakubo,Sunto-gun,Shizuoka
TEL	055-989-5222
Homepage URL
Email	n.nishioka@scchr.jp

Sponsor
Institute	Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization	None
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	Shizuoka cancer center
Address	1007, Shimo-nagakubo,Sunto-gun,Shizuoka
Tel	055-989-5222
Email	irb@scchr.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 07 Month 13 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	Open public recruiting
Date of protocol fixation	2021 Year 06 Month 28 Day
Date of IRB	2021 Year 06 Month 28 Day
Anticipated trial start date	2021 Year 06 Month 28 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 07 Month 13 Day
Last modified on	2021 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051155