Unique ID issued by UMIN | UMIN000029605 |
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Receipt number | R000033813 |
Scientific Title | Phase2, single arm investigator initiated study of Atezolizumab in advanced or recurrent non-small cell lung cancer patients for biomarker research |
Date of disclosure of the study information | 2017/11/01 |
Last modified on | 2020/08/12 13:31:45 |
Phase2, single arm investigator initiated study of Atezolizumab in advanced or recurrent non-small cell lung cancer patients for biomarker research
Atezolizumab NSCLC study
Phase2, single arm investigator initiated study of Atezolizumab in advanced or recurrent non-small cell lung cancer patients for biomarker research
Atezolizumab NSCLC study
Japan |
Lung cancer
Pneumology |
Malignancy
YES
To evaluate the efficacy and safety of Atezolizumab in patients with advanced or recurrent non-small cell lung cancer for biomarker research
Safety,Efficacy
Exploratory
Phase II
Objective response rate: ORR
Disease control rate: DCR
Progression free survival: PFS
Overall survival: OS
Incidence of Adverse Events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
1200 mg of Atezolizumab is administered by intravenous infusion once every 3 weeks(q3w)
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically or cytologically confirmed, Stage 3B/4or recurrent NSCLC
2) Available biopsy lesion prior to study treatment
The following is also acceptable,
aspiration biopsy, brushing, cell pellet from pleural effusion
3) Patients who have received platinum-based chemotherapy to NSCLC, and confirmed aggravation during or after treatment
In addition,
・patients with EGFR mutations confirmed PD/ not tolerable by treatment of TKI
・patients with ALK fusion gene confirmed PD/ not tolerable by treatment of ALK inhibitor
1)Patients undergoing any approved anti-cancer therapy, including chemotherapy or hormonal therapy within 3 weeks prior to registration.
The following are exceptions,
・Hormone replacement therapy
・Oral contraceptive
2) Patients treated with an investigational agent within 28 days or participated in other clinical trial.
3) History of allergic reactions to Chinese Hamster Ovary(CHO)cell-derived biopharmaceuticals or ingredient of Atezolizumab
4) Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti PD1, and anti-PD-L1 therapeutic antibody
5) Treatment with systemic immunostimulatory agents (ex.Interferons, interleukin-2) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to registration
6)Treatment with systemic immunosuppressive medications (ex. prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents) within 14 days prior to registration
27
1st name | Koichi |
Middle name | |
Last name | Goto |
National Cancer Center Hospital East
Department of Thoracic Oncology
277-8577
6-5-1,Kashiwanoha,Kashiwa,Chiba,Japan
04-7133-1111
kgoto@east.ncc.go.jp
1st name | Keisuke |
Middle name | |
Last name | Kirita |
National Cancer Center Hospital East
Department of Thoracic Oncology
277-8577
6-5-1,Kashiwanoha,Kashiwa,Chiba,Japan
04-7133-1111
kkirita@east.ncc.go.jp
National Cancer Center Hospital East
CHUGAI PHARMACEUTICAL CO., LTD
Profit organization
Office of IRB
6-5-1,Kashiwanoha,Kashiwa,Chiba,Japan
04-7133-1111
irboffice@east.ncc.go.jp
NO
2017 | Year | 11 | Month | 01 | Day |
Unpublished
Completed
2017 | Year | 08 | Month | 30 | Day |
2017 | Year | 10 | Month | 18 | Day |
2017 | Year | 12 | Month | 04 | Day |
2019 | Year | 08 | Month | 30 | Day |
2017 | Year | 10 | Month | 18 | Day |
2020 | Year | 08 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033813
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