UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043663
Receipt No. 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 2021/03/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Department of Pulmonary Medicine and Oncology
Zip code 113-8602
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL 03-3822-2131
Email agemma@nms.ac.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name OKADA
Organization EP-CRU CO., Ltd.
Division name Clinical Research Promotion Center
Zip code 162-0814
Address Acropolis TOKYO Bldg., 6-29 Shinogawamachi, Shinjuku-ku, Tokyo,Japan
TEL 03-5804-5045
Homepage URL
Email prj-jtail2@eps.co.jp

Sponsor
Institute CHUGAI PHARMACEUTICAL CO., LTD.
Institute
Department

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
Email 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 Open public 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 08 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Efficacy, Safety

Management information
Registered date
2021 Year 03 Month 18 Day
Last modified on
2021 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049847

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.