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 | 2025/01/24 10:55:45 |
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)
The biomarker exploratory study in prospective multicenter observational study of atezolizumab combination therapy in lung cancer (J-TAIL-2)
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)
The biomarker exploratory study in prospective multicenter observational study of atezolizumab combination therapy in lung cancer (J-TAIL-2)
Japan |
Non-small cell lung cancer or extensive disease small cell lung cancer
Pneumology | Chest surgery |
Malignancy
NO
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.
Others
Exploring Biomarkers
Exploratory
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.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
< 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.
450
1st name | Akihiko |
Middle name | |
Last name | GENMA |
Nippon Medical School
President
113-8602
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
2021 | Year | 03 | Month | 18 | Day |
Unpublished
Main results already published
2021 | Year | 01 | Month | 21 | Day |
2021 | Year | 01 | Month | 21 | Day |
2021 | Year | 03 | Month | 22 | Day |
2023 | Year | 02 | Month | 03 | Day |
2023 | Year | 06 | Month | 30 | Day |
2023 | Year | 08 | Month | 30 | Day |
Efficacy, Safety
2021 | Year | 03 | Month | 18 | Day |
2025 | Year | 01 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049847