UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052228 |
|---|---|
| Receipt number | R000059615 |
| Scientific Title | Efficacy and safety of initial treatment (combination immunotherapy or chemotherapy + ICI) in advanced non-small cell lung cancer patients (TPS 1-49%): A multicenter retrospective observational study (TOPGAN2023-01) |
| Date of disclosure of the study information | 2023/09/18 |
| Last modified on | 2024/05/08 07:49:37 |
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Basic information
Public title
Efficacy and safety of initial treatment (combination immunotherapy or chemotherapy + ICI) in advanced non-small cell lung cancer patients (TPS 1-49%): A multicenter retrospective observational study (TOPGAN2023-01)
Acronym
The initial treatment (combination immunotherapy or chemotherapy + ICI) in advanced non-small cell lung cancer (TPS 1-49%)
Scientific Title
Efficacy and safety of initial treatment (combination immunotherapy or chemotherapy + ICI) in advanced non-small cell lung cancer patients (TPS 1-49%): A multicenter retrospective observational study (TOPGAN2023-01)
Scientific Title:Acronym
Efficacy and safety of initial treatment (combination immunotherapy or chemotherapy + ICI) in advanced non-small cell lung cancer patients (TPS 1-49%): A multicenter retrospective observational study (TOPGAN2023-01)
Region
| Japan |
Condition
Condition
non small cell carcinoma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the treatment efficacy and safety of initial therapy (chemotherapy plus immune checkpoint inhibitors, immune checkpoint inhibitors plus immune checkpoint inhibitors and chemotherapy) for advanced non-small cell lung cancer (TPS 1-49%), and to elucidate the current state of treatment choices in routine clinical practice
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1-year survival rate, 2-year survival rate
Key secondary outcomes
PFS OS ORR safety
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Pathologically diagnosed as NSCLC (Non-Small Cell Lung Cancer)
2 PD-L1 expression (1-49%) has been confirmed (and TPS is counted)
3 Treatment progress can be collected based on medical records
Key exclusion criteria
1 Positive for genetic mutations (EGFR common mutation/ALK), LCNEC
2 The attending physician has deemed the patient ineligible for registration in this study.
3 Has an active concurrent cancer that affects prognosis
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | HISASHI |
| Middle name | |
| Last name | TANAKA |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
0368562
Address
5 Zaifu-cho Hirosaki
TEL
0172395468
xyghx335@gmail.com
Public contact
Name of contact person
| 1st name | HISASHI |
| Middle name | |
| Last name | TANAKA |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
0368562
Address
5 Zaifu-cho Hirosaki
TEL
0172395468
Homepage URL
https://hirosaki-u.bvits.com/rinri/publish.aspx
xyghx335@gmail.com
Sponsor or person
Institute
department of respiratory medicine hirosaki university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
TOPGAN Group participating institutions
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical School Ethics Committee
Address
5 Zaifu-cho Hirosaki
Tel
0172-33-5111
rinri@hirosaki-u.ac.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 | 09 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2023 | Year | 09 | Month | 17 | Day |
Last modified on
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059615
