UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041263
Receipt number R000047121
Scientific Title 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
Date of disclosure of the study information 2020/08/01
Last modified on 2023/01/31 09:11:36

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Basic information

Public title

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

Acronym

Prospective multicenter observational study of atezolizumab combination therapy in lung cancer (J-TAIL-2)

Scientific Title

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

Scientific Title:Acronym

Prospective multicenter observational study of atezolizumab combination therapy in lung cancer (J-TAIL-2)

Region

Japan


Condition

Condition

Non-small cell lung cancer and extensive disease small cell lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This prospective, observational study is to assess the efficacy and safety of atezolizumab combination therapy for patients with advanced non-small cell lung cancer and extensive disease small cell lung cancer in clinical practice.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

12 month-survival rate

Key secondary outcomes

(1) Overall Survival: OS
(2) 6 month-survival rate
(3) Progression free survival: PFS
(4) PFS rate (at 6,12 months)
(5) Time to Treatment Failure: TTF
(6) TTF rate (at 6,12 months)
(7) Post-treatment transfer rate
(8) Overall Response Rate: ORR
(9) Duration of Response: DOR
(10) Disease Control Rate: DCR
(11) Incidence rate of Adverse Events
(12) Comprehensive geriatric assessment(G8)
(13) Analysis of immune-related adverse events (irAE)
(14) Efficacy/safety by subpopulation or baseline factor characteristics

Exploratory Endpoints
(1) Survival rate (at 18,24 months)
(2) PFS rate (at 18,24 months)
(3) TTF rate (at 18,24 months)


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

< 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 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.

<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 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

< 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

1200


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

113-0022

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

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


Email

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

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

2020 Year 08 Month 01 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

2020 Year 07 Month 03 Day

Date of IRB

2020 Year 06 Month 18 Day

Anticipated trial start date

2020 Year 08 Month 17 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 31 Day

Date analysis concluded

2023 Year 11 Month 30 Day


Other

Other related information

Efficacy, Safety


Management information

Registered date

2020 Year 07 Month 30 Day

Last modified on

2023 Year 01 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047121


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name