Unique ID issued by UMIN | UMIN000033411 |
---|---|
Receipt number | R000038092 |
Scientific Title | Prospective study for the usefulness of single nucleotide polymorphism of immune related genes as a predictive factor of nivolumab effect for the patients with advanced non-small cell lung cancer |
Date of disclosure of the study information | 2018/07/17 |
Last modified on | 2019/07/18 17:19:10 |
Prospective study for the usefulness of single nucleotide polymorphism of immune related genes as a predictive factor of nivolumab effect for the patients with advanced non-small cell lung cancer
Prospective study of the nivolumab effect with respect to single nucleotide polymorphism of immune related genes
Prospective study for the usefulness of single nucleotide polymorphism of immune related genes as a predictive factor of nivolumab effect for the patients with advanced non-small cell lung cancer
Prospective study of the nivolumab effect with respect to single nucleotide polymorphism of immune related genes
Japan |
Non-small cell lung carcinoma
Medicine in general | Pneumology |
Malignancy
YES
To determine the efficacy of nivolumab, evaluate treatment response with respect to immune-related gene SNPs among patients with NSCLC.
Efficacy
Confirmatory
Progression free survival after administration of nivolumab with respect to immune-related gene SNPs.
Immune-related adverse events after administration of nivolumab with respect to immune-related gene SNPs.
Observational
18 | years-old | <= |
Not applicable |
Male and Female
1) Written informed consent.
2) Age 18 or over.
3) Patients with non-small cell lung cancer diagnosed by histology or cytology.
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
5) With one or more measurable disease (RECIST ver.1.1). Radiated tumor be excluded.
6) Major organs are held by the examination value within 14 days and clinical examination at the start of treatment meets the following criteria
Neut >= 2,500/mm3
Lym>= 500/ul
Plt>= 100,000/ul
Hb >= 9.0 g/dL
CRE <= 1.5 mg/dL
T-bil <= x2 facility standard
AST/ALT <= x3 facility standard
7) No previus immune-checkpoint inhibitors treatment.
1) Chemotherapy was used in the past 21 days. Exceptionally administration of tyrosine kinase inhibitors are not to be excluded.
2)Patients with symptomatic brain metastases and meningeal metastases. However, clinically stable brain metastasis cases can be registered.
3) Uncontrolled pleural effusion, pericardial effusion, and/or ascites.
4) Uncontrolled hyperkalemia.
5) Active double cancer within 5years of the first day of nivolumab treatment.
6) Pregnant or breast-feeding female patients.
7) Autoimmune disease.
8) Evident pulmonary fibrosis, organized pneumonia, drug-induced pneumonia or interstitial lung disease. Patients with active pneumonia at screening CT.
9) Serum albumin < 2.5g/dl
10) Patients with active infectious disease (HBV hepatitis, tuberculosis, pneumonia, sepsis etc.)
11) Ptients with serious heart disease.
12) Attenuated live vaccine within 4 weeks of the first dose of nivolumab, or suppose to be needed during the treatment.
13) Immunostimulant (INF, IL-2, etc) within 6 weeks.
14) Immunosuppressant (predonisoron, cyclophosphamide, azathioprine, methotrexate, etc) within 2 weeks.
112
1st name | Hiroaki |
Middle name | |
Last name | Ozasa |
Kyoto University
Department of Respiratory Medicine
606-8507
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
075-751-3830
ozahiro@kuhp.kyoto-u.ac.jp
1st name | Takashi |
Middle name | |
Last name | Nomizo |
Kyoto University
Department of Respiratory Medicine
606-8507
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
075-751-3830
http://kukonai.com/
gnomizo@kuhp.kyoto-u.ac.jp
Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
ONO PHARMACEUTICAL CO., LTD. Bristol-Myers Squibb K.K.
Profit organization
Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
075-751-3830
ozahiro@kuhp.kyoto-u.ac.jp
NO
京都大学医学部附属病院(京都府)
2018 | Year | 07 | Month | 17 | Day |
Unpublished
Preinitiation
2018 | Year | 07 | Month | 18 | Day |
2019 | Year | 08 | Month | 01 | Day |
2023 | Year | 07 | Month | 31 | Day |
This study is a prospective observational study to investigate the association between immune-related gene polymorphism and nivolumab treatment in patients with NSCLC.
2018 | Year | 07 | Month | 17 | Day |
2019 | Year | 07 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038092