UMIN-CTR Clinical Trial

Basic information
Public title	Medical team treatment decision of immune-checkpoint inhibitor in non-small cell lung cancer
Acronym	Medical team treatment decision of immune-checkpoint inhibitor in non-small cell lung cancer
Scientific Title	Medical team treatment decision of immune-checkpoint inhibitor in non-small cell lung cancer
Scientific Title:Acronym	Medical team treatment decision of immune-checkpoint inhibitor in non-small cell lung cancer
Region	Japan

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

Objectives
Narrative objectives1	Early identification of beneficial patients in patients treated with immune checkpoint inhibitors
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The correct rate of decision on 28 days after the start of administration
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Histologically or cytologically confirmed non-small cell lung cancer 2 At least one regimen or more of chemotherapy has been performed 3 18 years-old or over 4 Patients were judged appropriate by the attending physician as subjects of immune checkpoint inhibitors 5 Whether or not there is an evaluable lesion is not required 6 Patients who have adequate organ function 7 Patients provided written imformed consent
Key exclusion criteria	1 Patients who the physician judges unsuitable for this study 2 Patients who had pretreatment with immune checkpoint inhibitor
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomonori Hirashima
Organization	Osaka Habikino medical center
Division name	Department of thoracic oncology
Zip code
Address	3-7-1 habikino habikino-city OSAKA
TEL	0729572121
Email	hirashimat@opho.jp

Public contact
Name of contact person	1st name Middle name Last name Hidekazu Suzuki
Organization	Osaka Habikino Medical Center
Division name	Department of Thoracic oncology
Zip code
Address	3-7-1 habikino habikino-city OSAKA
TEL	0729572121
Homepage URL
Email	suzukih@opho.jp

Sponsor
Institute	Osaka Habikino Medical Center
Institute
Department

Funding Source
Organization	none
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
Address
Tel
Email

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	大阪はびきの医療センター（大阪府）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 12 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	No longer recruiting
Date of protocol fixation	2018 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date	2018 Year 03 Month 12 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study

Management information
Registered date	2018 Year 03 Month 06 Day
Last modified on	2018 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036081

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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