UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037777
Receipt number R000043080
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
Date of disclosure of the study information 2019/08/22
Last modified on 2022/02/22 21:47:23

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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 or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043080


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name