UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter retrospective study investigating the safety and efficacy of immune checkpoint inhibitors in lung cancer with interstitial pneumonia
Acronym	A multicenter retrospective study investigating the safety and efficacy of immune checkpoint inhibitors in lung cancer with interstitial pneumonia
Scientific Title	A multicenter retrospective study investigating the safety and efficacy of immune checkpoint inhibitors in lung cancer with interstitial pneumonia
Scientific Title:Acronym	A multicenter retrospective study investigating the safety and efficacy of immune checkpoint inhibitors in lung cancer with interstitial pneumonia
Region	Japan

Condition
Condition	Lung cancer with interstitial pneumonia
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We retrospectively examine the safety and efficacy of immune checkpoint inhibitors in primary lung cancer with interstitial pneumonia.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of drug-induced lung injury as an immune-related adverse event and rate of serious adverse events in patients treated with immune checkpoint inhibitors for primary lung cancer with interstitial pneumonia
Key secondary outcomes	1) Response rate of immune checkpoint inhibitors 2) Progression-free survival 3) Overall survival 4) Duration of treatment

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) Patients diagnosed with primary lung cancer 2) Patients with interstitial pneumonia 3) Patients who received immune checkpoint inhibitors
Key exclusion criteria	1) Radiation pneumonia 2) Drug-induced pneumonia 3) Interstitial lung abnormality
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kazuma Middle name Last name Kishi
Organization	Toho University School of Medicine
Division name	Division of Respiratory Medicine
Zip code	143-8542
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL	03-3762-4151
Email	kazuma.kishi@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Kazutoshi Middle name Last name Isobe
Organization	Toho University School of Medicine
Division name	Division of Respiratory Medicine
Zip code	143-8542
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL	03-3762-4151
Homepage URL
Email	kazutoshiisobe@med.toho-u.ac.jp

Sponsor
Institute	Toho University
Institute
Department

Funding Source
Organization	the Ministry of Health, Labour and Welfare of Japan awarded to the Study Group on Diffuse Pulmonary Disorders, Scientific Research/Research on intractable disease.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Toho University School of Medicine Ethics Committee
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
Tel	03-3762-4151
Email	med.rinri@ext.toho-u.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	2021 Year 04 Month 20 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 02 Month 25 Day
Date of IRB	2021 Year 04 Month 09 Day
Anticipated trial start date	2021 Year 04 Month 20 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	N/A

Management information
Registered date	2021 Year 04 Month 19 Day
Last modified on	2021 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050228