UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030457
Receipt number R000034774
Scientific Title Phase II trial of early secondary treatment with nibolumab for non-small cell lung cancer
Date of disclosure of the study information 2018/01/01
Last modified on 2021/06/21 14:17:02

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Basic information

Public title

Phase II trial of early secondary treatment with nibolumab for non-small cell lung cancer

Acronym

Early secondary treatment with nibolumab for NSCLC

Scientific Title

Phase II trial of early secondary treatment with nibolumab for non-small cell lung cancer

Scientific Title:Acronym

Early secondary treatment with nibolumab for NSCLC

Region

Japan


Condition

Condition

non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The effectiveness and safety of early nibolab secondary treatment after primary treatment with platinum drug combination.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Disease control rate at 24 weeks after initiation of nivolumab therapy

Key secondary outcomes

Progression-free survival, Overall survival, Time to treatment failure, Response rate, Adverse events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Nivolumab 3mg/kg every 2 weeks

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

Pathologically diagnosed non-small-cell
Non-small-cell lung cancer of stage IIIB or IV
Reccurence of operation or concurrent chemoradiotherapy
Patients without driver gene mutation (i.e. EGFR/ALK/RET/ROS1)
Expression of PD-L1 in adenocarcinoma are 0-49%
Expression of PD-L1 in squamouscarcinoma are 1-49%
Adequate organ function
3 months or longer expected survival
Written informed consent
Age over 20 years old
ECOG PS 0-1
Measurable lesion

Key exclusion criteria

Active auto-immune disease
An inappropriate case judged by doctor in charge

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kazuyoshi
Middle name
Last name Imaizumi

Organization

Fujita Health University School

Division name

Medicine department of pulmonary

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi

TEL

0562-93-9241

Email

jeanluc@fujita-hu.ac.jp


Public contact

Name of contact person

1st name Yasuhiro
Middle name
Last name Goto

Organization

Fujita Health University School

Division name

Medicine department of pulmonary

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi

TEL

0562-93-9241

Homepage URL


Email

gotoyasu510@hotmail.com


Sponsor or person

Institute

Fujita Health University School

Institute

Department

Personal name



Funding Source

Organization

Fujita Health University School

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

Fujita Health University School

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi

Tel

0562-93-9241

Email

gotoyasu510@hotmail.com


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

2018 Year 01 Month 01 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

Completed

Date of protocol fixation

2017 Year 11 Month 15 Day

Date of IRB

2017 Year 11 Month 15 Day

Anticipated trial start date

2018 Year 01 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 12 Month 18 Day

Last modified on

2021 Year 06 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034774


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name