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 |
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
Prospective multicenter observational study of atezolizumab combination therapy in lung cancer (J-TAIL-2)
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
Prospective multicenter observational study of atezolizumab combination therapy in lung cancer (J-TAIL-2)
Japan |
Non-small cell lung cancer and extensive disease small cell lung cancer
Pneumology | Chest surgery |
Malignancy
NO
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.
Safety,Efficacy
12 month-survival rate
(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)
Observational
20 | years-old | <= |
Not applicable |
Male and Female
< 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.
< 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.
1200
1st name | Akihiko |
Middle name | |
Last name | GENMA |
Nippon Medical School
President
113-0022
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
03-3822-2131
agemma@nms.ac.jp
1st name | Jun |
Middle name | |
Last name | OKADA |
EPS Corporation
Clinical Research Center Real World Evidence Business Headquarters
162-0814
Acropolis TOKYO Bldg., 6-29 Shinogawamachi, Shinjuku-ku, Tokyo,Japan
03-5804-5045
prj-jtail2@eps.co.jp
CHUGAI PHARMACEUTICAL CO., LTD.
CHUGAI PHARMACEUTICAL CO., LTD.
Profit organization
The Japan Lung Cancer Society
Non-Profit Organization MINS Institutional Review Board
1-15-14, Dogenzaka, Shibuya, Tokyo, Japan
03-6416-1868
Npo-mins@j-irb.com
NO
2020 | Year | 08 | Month | 01 | Day |
Unpublished
No longer recruiting
2020 | Year | 07 | Month | 03 | Day |
2020 | Year | 06 | Month | 18 | Day |
2020 | Year | 08 | Month | 17 | Day |
2023 | Year | 02 | Month | 03 | Day |
2023 | Year | 06 | Month | 30 | Day |
2023 | Year | 08 | Month | 31 | Day |
2023 | Year | 11 | Month | 30 | Day |
Efficacy, Safety
2020 | Year | 07 | Month | 30 | Day |
2023 | Year | 01 | Month | 31 | Day |
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 |