UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036606
Receipt number R000041556
Scientific Title Multicenter PK PD Study of Immune Checkpoint Inhibitors for Patients Aged 75 or Older with Advanced Non Small Cell Lung Cancer.
Date of disclosure of the study information 2019/04/26
Last modified on 2022/10/28 09:33:04

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Basic information

Public title

PK/PD study of Pembrolizumab

Acronym

PK/PD study of Pembrolizumab

Scientific Title

Multicenter PK PD Study of Immune Checkpoint Inhibitors for Patients Aged 75 or Older with Advanced Non Small Cell Lung Cancer.

Scientific Title:Acronym

Elderly Pembro trial

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Analyses for K/PD/PGX, efficacy & safety, and biomarker in elderly patients with non-small cell lung cancer treated with pembrolizumab.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Pharmacokinetics of pembrolizumab

Key secondary outcomes

1)Responce rate
2)Disease control rate
3)Progression free survival
4)Overall survival
5)Adverse event
6)PK/PD/PGx
7)Biomarker


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

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histlogically or cytologically confirmed EGFR mutation positive non small cell lung cancer(NSCLC)
2)Patients who are going to treat with Pembrolizumab monotherapy or combination therapy.
3)No object about organ function, prior treatment, performance status, or measurable lesion.
4)More than 75 years old
5)Written informed consent

Key exclusion criteria

1)Patients who have treated with Pembrolizumab
2)Patients who denied to collect sample
3)Patients whose attending doctor consider as inappropriate for this study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Akinobu
Middle name
Last name Hamada

Organization

National Cancer Center Research Institute

Division name

Division of Molecular Pharmacology

Zip code

104-0045

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo, JAPAN

TEL

03-3542-2511

Email

akhamad@ncc.go.jp


Public contact

Name of contact person

1st name Shigehiro
Middle name
Last name Yagishita

Organization

National Cancer Center Research Institute

Division name

Division of Molecular Pharmacology

Zip code

104-0045

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo, JAPAN

TEL

03-3542-2511

Homepage URL


Email

syagishi@ncc.go.jp


Sponsor or person

Institute

National Cancer Center Research Institute
Division of Molecular Pharmacology

Institute

Department

Personal name



Funding Source

Organization

AMED

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

National Cancer Center

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo, JAPAN

Tel

03-3542-2511

Email

syagishi@ncc.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

2019 Year 04 Month 26 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

100

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

2019 Year 01 Month 04 Day

Date of IRB

2019 Year 03 Month 25 Day

Anticipated trial start date

2019 Year 03 Month 25 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

Efficacy, safety, PK/PD/PGx, and biomarker study for elderly patients with non-small cell lung cancer treated with pembrolizumab.


Management information

Registered date

2019 Year 04 Month 26 Day

Last modified on

2022 Year 10 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041556


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name