UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046353
Receipt number R000052616
Scientific Title Safety and efficacy of combination immunotherapy with nivolumab and ipilimumab for elderly lung cancer patients: a cohort study
Date of disclosure of the study information 2021/12/12
Last modified on 2021/12/11 13:10:24

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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 or person

Institute

National Hospital Organization Kyoto Medical Center

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052616


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name