UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055395 |
|---|---|
| Receipt number | R000063117 |
| Scientific Title | Epidemiological study of second-line treated non-small cell lung cancer (NSCLC) with HER2 mutation in Japan |
| Date of disclosure of the study information | 2024/09/02 |
| Last modified on | 2025/04/16 11:10:55 |
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Basic information
Public title
Epidemiological study of second-line treated non-small cell lung cancer (NSCLC) with HER2 mutation in Japan
Acronym
Epidemiological study of second-line treated non-small cell lung cancer (NSCLC) with HER2 mutation in Japan
Scientific Title
Epidemiological study of second-line treated non-small cell lung cancer (NSCLC) with HER2 mutation in Japan
Scientific Title:Acronym
Epidemiological study of second-line treated non-small cell lung cancer (NSCLC) with HER2 mutation in Japan
Region
| Japan |
Condition
Condition
non-small cell lung cancer (NSCLC)
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To characterize the patient background among second-line treated patients with HER2-mutated NSCLC at the time of registration in the C-CAT database.
Basic objectives2
Others
Basic objectives -Others
Epidemiological study using C-CAT database
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Patient information at registration to C-CAT database
1. Patient characteristics
2. Clinical characteristics
3. Genetic alterations
Key secondary outcomes
1. Second-line lung cancer treatment types
2. Overall response rate (ORR)
3. Disease control rate (DCR)
4. Time on treatment (ToT)
5. Overall survival (OS)
6. Reasons for the second-line lung cancer treatment termination
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 18 years and older at registration in the C-CAT database
2. Patients who have NSCLC diagnostic information
3. Patients with a medical record of second-line lung cancer treatment information in the C-CAT database
Key exclusion criteria
None.
Target sample size
2700
Research contact person
Name of lead principal investigator
| 1st name | Hana |
| Middle name | |
| Last name | Kimura |
Organization
Nippon Boehringer Ingelheim Co., Ltd
Division name
Medicine Division Real World Evidence Japan
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo
TEL
070-2674-6485
hana.kimura@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Hana |
| Middle name | |
| Last name | Kimura |
Organization
Nippon Boehringer Ingelheim Co., Ltd
Division name
Medicine Division Real World Evidence Japan
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo
TEL
070-2674-6485
Homepage URL
hana.kimura@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takahashi Clinic Ethics Committee
Address
Medicalhat 1F, 5-1-31, Iwayakita-machi, Nada-ku, Kobe-shi, Hyogo 657-0846
Tel
078-882-6432
kishimoto.satoshi@neues.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
| 2024 | Year | 09 | Month | 02 | 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
2700
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
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 18 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 18 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 18 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 26 | Day |
Other
Other related information
1. A non-interventional/observational, cohort study using existing data (C-CAT database).
2. The C-CAT database enrollment began in June 2019, and this study will use data on the date of data extraction in 2024.
3. The objective of this study is to comprehensively characterize the second-line treated patients diagnosed with HER2-mutated NSCLC in the real-world settings.
Management information
Registered date
| 2024 | Year | 09 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063117
