UMIN-CTR Clinical Trial

Basic information
Public title	A multi-institutional retrospective study of the efficacy and safety of immune checkpoint blockade for patients with non-small cell lung cancer and pre-existing autoimmune disease (NEJ047)
Acronym	NEJ047
Scientific Title	A multi-institutional retrospective study of the efficacy and safety of immune checkpoint blockade for patients with non-small cell lung cancer and pre-existing autoimmune disease (NEJ047)
Scientific Title:Acronym	NEJ047
Region	Japan

Condition
Condition	Patients with non-small cell lung cancer and pre-existing autoimmune disease
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of immune checkpoint blockade (ICB) for patients with non-small cell lung cancer and pre-existing autoimmune disease (AID)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Ratio of acute exacerbation of AID in patients with NSCLC and AID who received ICB 2. Rate of serious immune related adverse events (irAE) in patients with NSCLC and AID who received ICB
Key secondary outcomes	1. Objective response rate (ORR) 2. Progression-free survival (PFS) 3. Overall survival (OS) 4. Time to treatment failure (TTF)

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	1. Advanced/Relapsed non-small cell lung cancer 2. Patients with pre-existing autoimmune disease 3. Either patients who received immune checkpoint inhibitors or not can be included.
Key exclusion criteria	None
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazuhisa Middle name Last name Takahashi
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Zip code	113-8421
Address	2-2-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	kztakaha@juntendo.ac.jp

Public contact
Name of contact person	1st name Tetsuhiko Middle name Last name Asao
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Zip code	113-8421
Address	2-2-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	tasao@juntendo.ac.jp

Sponsor
Institute	North East Japan Study Group
Institute
Department

Funding Source
Organization	Juntendo University Graduate School of Medicine
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	Juntendo University Hospital Institutional Review Board
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel	03-3813-3111
Email	kenkyu5858@juntendo.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	2020 Year 05 Month 25 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	2020 Year 02 Month 15 Day
Date of IRB	2020 Year 03 Month 19 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective observational study

Management information
Registered date	2020 Year 05 Month 25 Day
Last modified on	2022 Year 11 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046248