UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051330 |
|---|---|
| Receipt number | R000058556 |
| Scientific Title | Integrated analysis of the IMpower130 and IMpower132 trials |
| Date of disclosure of the study information | 2023/06/13 |
| Last modified on | 2023/06/13 12:20:04 |
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Basic information
Public title
Integrated analysis of the IMpower130 and IMpower132 trials
Acronym
Integrated analysis of the IMpower130 and IMpower132 trials
Scientific Title
Integrated analysis of the IMpower130 and IMpower132 trials
Scientific Title:Acronym
Integrated analysis of the IMpower130 and IMpower132 trials
Region
| Japan |
Condition
Condition
unresectable locally advanced non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the Atezolizumab combination regimen in patients with non-squamous non-small cell lung cancer with patient backgrounds such as the elderly and decreased renal function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy (progression-free survival, overall survival, response rate) and safety by subgroup
Key secondary outcomes
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
Patients with non-squamous non-small-cell lung cancer enrolled in Studies IMpower130 and IMpower132 who are judged by the ethics review committee to be eligible for analysis in this study.
Key exclusion criteria
Patients with non-squamous non-small-cell lung cancer enrolled in Studies IMpower130 and IMpower132 who are judged by the ethics review committee to be ineligible for analysis in this study.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shunichiro |
| Middle name | |
| Last name | Iwasawa |
Organization
Chugai Pharmaceutical Co., Ltd
Division name
Medical Affairs Div.
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-Chome, Chuo-Ku Tokyo
TEL
03-3273-0866
cma-clinicaltrial@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kobayashi |
Organization
Chugai Pharmaceutical Co., Ltd
Division name
Medical Affairs Div.
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-Chome, Chuo-Ku Tokyo
TEL
03-3273-0866
Homepage URL
cma-clinicaltrial@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd
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
Ethics Committee for Research Using Human-Derived Samples (Committee Number: 11001059)
Address
1-1 Nihonbashi-Muromachi 2-Chome, Chuo-Ku Tokyo
Tel
03-3281-6611
cma-clinicaltrial@chugai-pharm.co.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 | 06 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
IMpower130 (GO29537) _NCT02367781
IMpower132 (GO29438) _NCT02657434
Management information
Registered date
| 2023 | Year | 06 | Month | 13 | Day |
Last modified on
| 2023 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058556
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
