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
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
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
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
