Unique ID issued by UMIN | UMIN000023822 |
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Receipt number | R000027442 |
Scientific Title | Prospective study of evaluation to the predictive biomarker of Nivolumab by tumor tissue specimen and neighboring bronchoaveolar lavage fluid (BALF) and Blood |
Date of disclosure of the study information | 2016/08/30 |
Last modified on | 2019/01/27 22:35:20 |
Prospective study of evaluation to the predictive biomarker of Nivolumab by tumor tissue specimen and neighboring bronchoaveolar lavage fluid (BALF) and Blood
Evaluation to the predictive biomarker of Nivolumab by Tumor tissue, BALF, and Blood
Prospective study of evaluation to the predictive biomarker of Nivolumab by tumor tissue specimen and neighboring bronchoaveolar lavage fluid (BALF) and Blood
Evaluation to the predictive biomarker of Nivolumab by Tumor tissue, BALF, and Blood
Japan |
previously treated patients with advanced non-small-cell lung cancer
Medicine in general | Pneumology | Hematology and clinical oncology |
Malignancy
YES
We will reveal predictive biomarker for nivolmab
Others
Evaluate the tumor tissue, BALF, and blood collection between before nivolumab treatment and at the disease progression or appearing the new lesion in lung
We will reveal predictive biomarker for nivolmab by evaluate the tumor tissue, BALF, and blood collection.
Progression free Survival, Overall Survival, Response Rate, Disease Control Rate, safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
Performe tumor biopsy, BAL, and blood collection before the Nivolumab treatment.
Performe tumor biopsy, BAL, and blood collection at disease progression and appearing new lesion in the lung during Nivolumab treatment
20 | years-old | <= |
Not applicable |
Male and Female
(1)Histologically or Cytologically documented non-small-cell lung cancer
(2)Stage VI or recurrent diseases without any indications for operation and radiotherapy
(3)Have measuarable lesion in lung by using the RECIST ver1.1 (Response Evaluation Criteria In Solid Tumors) criteria and can performe tumor biopsy by bronchoscopy
(4)Must be 20 or more years old at tne time of consent
(5)Have Eastern Coopperative Oncology Group Perfoemance Status (ECOG PS) 0-1
(6)Have adequate organ function within two weeks before study entry.
(7)Estimate life expectancy of at least 12 weeks
(8)Have signed an informed consent document
(1)With interstitial pneumonia or pulmonary fibrosis on a chest X-ray
(2)Clinically significant drug allergy
(3)Presencee of other active malignancy
(4)With pericardial effusion, pleural effusion and ascites in need of treatment of drainage
(5)Positive serum HBs antigen
(6)With severe infection, cardiac diseases, diabates, hypertention, other severe complication
(7)Patients received palliative radiotherapy for brain metastases and bone metastases, except for the primary lesion within 2weeks.
(8)Pregnancy or lactating patients
(9)The case that be judged as the inappropriate object of the this examination
20
1st name | |
Middle name | |
Last name | Atsushi Kumanogoh |
Osaka University Medical School
Respiratory Medicine, Allergy and Rheumatic Diseases Osaka University Graduate School of Medicine
2-2 Yamada-oka, Suita, Osaka
+81-(0)6-6879-3830
kumanogo@imed3.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Motohiro Tamiya |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Thoracic Oncology
1-3-3 Nakamichi, Higashinari-ku, Osaka, Osaka
+81-(0)6-6972-1181
moto19781205@yahoo.co.jp
Respiratory Medicine, Allergy and Rheumatic Diseases Osaka University Graduate School of Medicine
ONO PHARMACEUTICAL CO., LTD.
Profit organization
Bristol-Myers Squibb
NO
大阪大学(大阪府)
大阪府立呼吸器・アレルギー医療センター(大阪府)
大阪府立成人病センター(大阪府)
2016 | Year | 08 | Month | 30 | Day |
Partially published
Completed
2016 | Year | 07 | Month | 19 | Day |
2016 | Year | 09 | Month | 01 | Day |
2016 | Year | 08 | Month | 29 | Day |
2019 | Year | 01 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027442
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