UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of combination immunotherapy with nivolumab and ipilimumab for elderly lung cancer patients: a cohort study
Acronym	Safety and efficacy of combination immunotherapy with nivolumab and ipilimumab for elderly lung cancer patients: a cohort study
Scientific Title	Safety and efficacy of combination immunotherapy with nivolumab and ipilimumab for elderly lung cancer patients: a cohort study
Scientific Title:Acronym	Safety and efficacy of combination immunotherapy with nivolumab and ipilimumab for elderly lung cancer patients: a cohort 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 determine the efficacy and safety of combination immunotherapy with ipilimumab and nivolumab for 75-year-old or older lung cancer patients compared with those for younger than 75 years of age
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	overall response rate, incidence of adverse events
Key secondary outcomes	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	Advanced or recurrent non-small cell lung cancer patients who receive combination immunotherapy with nivolumab and ipilimumab
Key exclusion criteria	None
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takuma Middle name Last name Imakita
Organization	Kyoto Medical Center
Division name	Division of Respiratory Medicine
Zip code	6128555
Address	1-1 Fukakusamukaihatacho, Fushimi, Kyoto, Japan
TEL	0756419161
Email	imakita-kyt@umin.ac.jp

Public contact
Name of contact person	1st name Takuma Middle name Last name Imakita
Organization	National Hospital Organization Kyoto Medical Center
Division name	Division of Respiratory Medicine
Zip code	6128555
Address	1-1 Fukakusamukaihatacho, Fushimi, Kyoto, Japan
TEL	0756419161
Homepage URL
Email	imakita-kyt@umin.ac.jp

Sponsor
Institute	National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Kyoto Medical Center
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	National Hospital Organization Kyoto Medical Center
Address	1-1 Fukakusamukaihatacho, Fushimi, Kyoto, Japan
Tel	0756419161
Email	404-chiken@mail.hosp.go.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 12 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	Enrolling by invitation
Date of protocol fixation	2021 Year 10 Month 22 Day
Date of IRB	2021 Year 10 Month 18 Day
Anticipated trial start date	2021 Year 12 Month 01 Day
Last follow-up date	2023 Year 10 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study: enrolling

Management information
Registered date	2021 Year 12 Month 11 Day
Last modified on	2021 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052616