UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043663 |
|---|---|
| Receipt number | R000049847 |
| Scientific Title | The exploratory study to evaluate biomarkers in prospective multicenter observational study of atezolizumab combination therapy in patients with unresectable, advanced and recurrent non-small cell lung cancer or extensive disease small cell lung cancer (J-TAIL-2) |
| Date of disclosure of the study information | 2021/03/18 |
| Last modified on | 2023/03/20 09:11:03 |
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Basic information
Public title
The exploratory study to evaluate biomarkers in prospective multicenter observational study of atezolizumab combination therapy in patients with unresectable, advanced and recurrent non-small cell lung cancer or extensive disease small cell lung cancer (J-TAIL-2)
Acronym
The biomarker exploratory study in prospective multicenter observational study of atezolizumab combination therapy in lung cancer (J-TAIL-2)
Scientific Title
The exploratory study to evaluate biomarkers in prospective multicenter observational study of atezolizumab combination therapy in patients with unresectable, advanced and recurrent non-small cell lung cancer or extensive disease small cell lung cancer (J-TAIL-2)
Scientific Title:Acronym
The biomarker exploratory study in prospective multicenter observational study of atezolizumab combination therapy in lung cancer (J-TAIL-2)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer or extensive disease small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is implemented in association with the study J-TAIL-2 ; prospective multicenter observational study of atezolizumab in patients with unresectable,locally advanced or metastatic non-small cell lung cancer, UMIN study ID : UMIN000041263, to evaluate biomarkers for selection of appropriate patients in treatment with atezolizumab combination therapy.
Basic objectives2
Others
Basic objectives -Others
Exploring Biomarkers
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the correlation of PD-L1 SNPs, protein expression levels in plasma, and an immune microenvironment of small cell lung cancer with efficacy and safety of atezolizumab combination therapy.
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
Inclusion/exclusion criteria of J-TAIL-2 study is to be applied.
< non-small cell lung cancer cohort>
(1) Patients 20 years of age or older at the time of signed consent.
(2) Patients with unresectable, advanced and recurrent non-small cell lung cancer.
(3) Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Clinical Use 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.
<extensive disease small cell lung cancer cohort>
(1) Patients 20 years of age or older at the time of signed consent.
(2) Patients with extensive disease small cell lung cancer.
(3) Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Clinical Use 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. However, the samples of dead cases can be used for the analysis of immune microenvironment of small cell lung cancer by disclosing information on this study.
Key exclusion criteria
< non-small cell lung cancer cohort>
(1) Patients who are unsuitable for enrolment into the study by the investigator's judgment.
<extensive disease small cell lung cancer cohort>
(1) Patients who are unsuitable for enrolment into the study by the investigator's judgment.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | GENMA |
Organization
Nippon Medical School
Division name
President
Zip code
113-8602
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
agemma@nms.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | OKADA |
Organization
EPS Corporation
Division name
Clinical Research Center Real World Evidence Business Headquarters
Zip code
162-0814
Address
Acropolis TOKYO Bldg., 6-29 Shinogawamachi, Shinjuku-ku, Tokyo,Japan
TEL
03-5804-5045
Homepage URL
prj-jtail2@eps.co.jp
Sponsor or person
Institute
CHUGAI PHARMACEUTICAL CO., LTD.
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
| 2021 | Year | 03 | 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
| 2021 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 03 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Efficacy, Safety
Management information
Registered date
| 2021 | Year | 03 | Month | 18 | Day |
Last modified on
| 2023 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049847
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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