UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033133 |
|---|---|
| Receipt number | R000037717 |
| Scientific Title | Prospective multicenter observational study of atezolizumab in patients with unresectable, locally advanced or metastatic non-small cell lung cancer |
| Date of disclosure of the study information | 2018/06/25 |
| Last modified on | 2023/09/07 09:10:57 |
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Basic information
Public title
Prospective multicenter observational study of atezolizumab in patients with unresectable, locally advanced or metastatic non-small cell lung cancer
Acronym
Prospective multicenter observational study of atezolizumab in lung cancer (J-TAIL)
Scientific Title
Prospective multicenter observational study of atezolizumab in patients with unresectable, locally advanced or metastatic non-small cell lung cancer
Scientific Title:Acronym
Prospective multicenter observational study of atezolizumab in lung cancer (J-TAIL)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This prospective, observational study is to assess the long-term effectiveness and safety of atezolizumab in patients with advanced non-small cell lung cancer in clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
18 month-survival rate
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients 20 years of age or older at the time of signed consent.
(2)Patients with locally advanced or metastatic non-small cell lung cancer.
(3)Patients who are scheduled to start atezolizumab monotherapy, based on the atezolizumab package insert and the Optimal Use Promotion Guideline.
(4)Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments.
Key exclusion criteria
(1)Patients who are considered to be unsuitable for enrolment into the study by the investigator's judgment.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | MITSUDOMI |
Organization
Kindai University Faculty of Medicine
Division name
Division of Thoracic Surgery
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-Sayama, Japan
TEL
072-366-0221
mitsudom@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Omura |
Organization
Mebix, Inc.
Division name
Clinical Research Operation
Zip code
105-0001
Address
8-21 Toranomon 3-chome, Minato-ku Tokyo, Japan
TEL
03-4362-4504
Homepage URL
j-tail@mebix.co.jp
Sponsor or person
Institute
CHUGAI PHARMACEUTICAL CO., LTD.
Medical Affairs
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Japan Lung Cancer Society
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
1-15-14, Dogenzaka, Shibuya, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2018 | Year | 06 | Month | 25 | 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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 16 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 07 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 14 | Day |
Other
Other related information
Efficacy, Safety
Management information
Registered date
| 2018 | Year | 06 | Month | 25 | Day |
Last modified on
| 2023 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037717
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
