UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042744
Receipt number R000048789
Scientific Title network meta-analysis of first-line treatment for ALK-positive NSCLC
Date of disclosure of the study information 2020/12/14
Last modified on 2021/12/20 13:02:06

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Basic information

Public title

network meta-analysis of first-line treatment for ALK-positive NSCLC

Acronym

NMA of 1L ALK inhibitors

Scientific Title

network meta-analysis of first-line treatment for ALK-positive NSCLC

Scientific Title:Acronym

NMA of 1L ALK inhibitors

Region

Japan


Condition

Condition

ALK-positive NSCLC

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Aim of this study is to compare first-line treatment for ALK-positive NSCLC.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

OS

Key secondary outcomes

PFS, ORR, AE(>g3), TRD


Base

Study type

Others,meta-analysis etc


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

English-written individually randomized controlled trials for ALK-positive NSCLC will be included. A trial should have recruited untreated, chemo-naive, or ALK naive patients.

Key exclusion criteria

None

Target sample size



Research contact person

Name of lead principal investigator

1st name Nobuyuki
Middle name
Last name Horita

Organization

Yokohama City University

Division name

Department of Pulmonology

Zip code

236-0004

Address

3-9, Fikuura, Kanazawa, Yokohama, Japan

TEL

+81457872800

Email

horitano@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Nobuyuki
Middle name
Last name Horita

Organization

Yokohama City University

Division name

Department of Pulmonology

Zip code

236-0004

Address

3-9, Fikuura, Kanazawa, Yokohama, Japan

TEL

+81457872800

Homepage URL


Email

horitano@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

None

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

NA

Address

NA

Tel

NA

Email

NA


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

2020 Year 12 Month 14 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

Terminated

Date of protocol fixation

2020 Year 12 Month 14 Day

Date of IRB

2020 Year 12 Month 14 Day

Anticipated trial start date

2020 Year 12 Month 14 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

The frequentist weighted least squares approach random-model network meta-analysis will be performed by the R software (Command: netmeta, Package: netmeta). An odds ratio (OR) of a binary outcome should be continuous corrected with 0.5 if necessary. OR and hazard ratio (HR) will be log converted prior to meta-analysis. P value less than 0.05 is considered significant.


Management information

Registered date

2020 Year 12 Month 14 Day

Last modified on

2021 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048789


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name