UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of immune checkpoint inhibitors in patients with non-small cell lung cancer other than adenocarcinoma or squamous cell carcinoma: multicenter retrospective observational study
Acronym	Efficacy of ICI in patients with NSCLC other than adenocarcinoma or squamous cell carcinoma in a multi-center retrospective study
Scientific Title	Efficacy of immune checkpoint inhibitors in patients with non-small cell lung cancer other than adenocarcinoma or squamous cell carcinoma: multicenter retrospective observational study
Scientific Title:Acronym	Efficacy of ICI in patients with NSCLC other than adenocarcinoma or squamous cell carcinoma in a multi-center retrospective study
Region	Japan

Condition
Condition	Non-small cell lung cancer other than adenocarcinoma or squamous cell carcinoma
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the efficacy of immune checkpoint inhibitors on non-small cell lung cancer other than adenocarcinoma or squamous cell carcinoma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression free survival
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	All patients who had unresectable non-small cell lung cancer other than adenocarcinoma or squamous cell carcinoma, and all patients received with immune checkpoint inhibitors
Key exclusion criteria	Patients with no or insufficient clinical information
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takafumi Middle name Last name Suda
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192 JAPAN
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	1st name Koichi Middle name Last name Miyashita
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192 JAPAN
TEL	053-435-2263
Homepage URL
Email	miya501@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University 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	Hamamatsu university school of medicine Research cooperation section research support staff
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192 JAPAN
Tel	053-435-2111
Email	rinri@hama-med.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	2019 Year 08 Month 22 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	Main results already published
Date of protocol fixation	2019 Year 06 Month 10 Day
Date of IRB	2019 Year 07 Month 31 Day
Anticipated trial start date	2019 Year 08 Month 22 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multi-center retrospective observational study

Management information
Registered date	2019 Year 08 Month 22 Day
Last modified on	2022 Year 02 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043080