UMIN-CTR 臨床試験登録情報の閲覧

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
Institute	Yokohama City University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048789