UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052814 |
|---|---|
| Receipt number | R000060254 |
| Scientific Title | Immunotherapy for KRAS Mutant Advanced Non-Small Cell Lung Cancer: A Systematic Review and Network Meta-analysis |
| Date of disclosure of the study information | 2023/11/16 |
| Last modified on | 2023/11/16 12:17:33 |
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Basic information
Public title
Immunotherapy for KRAS Mutant Advanced Non-Small Cell Lung Cancer: A Systematic Review and Network Meta-analysis
Acronym
Immunotherapy for KRAS Mutant Advanced Non-Small Cell Lung Cancer
Scientific Title
Immunotherapy for KRAS Mutant Advanced Non-Small Cell Lung Cancer: A Systematic Review and Network Meta-analysis
Scientific Title:Acronym
Immunotherapy for KRAS Mutant Advanced Non-Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Advanced non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of immune checkpoint inhibitors as monotherapy or in combination with platinum-based regimens for KRAS-positive advanced non-small cell lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
Progression Free Survival
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Phase III trials investigating the efficacy of immune checkpoint inhibitors as monotherapy or in combination with platinum agents for advanced Non-Small Cell Lung Cancer, with accessible KRAS mutation Information
Key exclusion criteria
Excluded from the analysis were phase 1/phase 2 trials, single-arm trials, observational studies, and meta-analyses. Studies lacking information on KRAS mutations were also excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Akinari |
| Middle name | |
| Last name | Tsukada |
Organization
National Center for Global Health and Medicine
Division name
Department of Respiratory Medicine
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL
+81-3-3202-7181
atsukada@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Akinari |
| Middle name | |
| Last name | Tsukada |
Organization
National Center for Global Health and Medicine
Division name
Department of Respiratory Medicine
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL
+81-3-3202-7181
Homepage URL
atsukada@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
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
National Center for Global Health and Medicine
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
Tel
+81-3-3202-7181
atsukada@hosp.ncgm.go.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
| 2023 | Year | 11 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will extract phase 3 trials involving immunotherapy, including immune checkpoint inhibitors, for advanced non-small cell lung cancer. We will focus on trials that include information on KRAS mutations. The data will be analyzed using the statistical software R to conduct a network meta-analysis.
Management information
Registered date
| 2023 | Year | 11 | Month | 16 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060254
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
