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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000026040 |
Receipt No. | R000029929 |
Scientific Title | Biomarker studies for potentially predicting response to nivolumab in patients with unresectable or recurrent non-small cell lung cancer |
Date of disclosure of the study information | 2017/02/07 |
Last modified on | 2018/12/16 |
Basic information | ||
Public title | Biomarker studies for potentially predicting response to nivolumab in patients with unresectable or recurrent non-small cell lung cancer | |
Acronym | Biomarker studies for nivolumab | |
Scientific Title | Biomarker studies for potentially predicting response to nivolumab in patients with unresectable or recurrent non-small cell lung cancer | |
Scientific Title:Acronym | Biomarker studies for nivolumab | |
Region |
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Condition | ||
Condition | unresectable or recurrent non-small cell lung cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the biomarkers for efficacy of nivolumab in patients with NSCLC |
Basic objectives2 | Others |
Basic objectives -Others | Evaluation of biomarker |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | To evaluate the biomarkers for efficacy of nivolumab using blood samples. |
Key secondary outcomes | response rate, overall survival, progression-free survival, rate of side effects |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Leucocyte>3,000/mm3 and <12,000/mm3
Hemoglobin>9.0 g/dL Platelet>100,000/mm3 AST<100 IU/L ALT<100 IU/L T.Bil<2.0 mg/dL Serum creatinine<1.5 mg/dL |
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Key exclusion criteria | (1)Subjects with autoimmune disease.
(2)Subjects with interstitial lung disease. (3)Receiving continuous systemic corticosteroid. (4)Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. (5)Patients with a history of hypersensitivity to nivolumab. (6)Dementia or psychological disorder difficult to participate in this clinical study. |
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Target sample size | 90 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kagoshima University Graduate School of Medical and Dental Sciences | ||||||
Division name | Department of General Thoracic Surgery | ||||||
Zip code | |||||||
Address | 8-35-1, Sakuragaoka, Kagoshima city, Japan | ||||||
TEL | 099-275-6490 | ||||||
m-sato@m2.kufm.kagoshima-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kagoshima University Graduate School of Medical and Dental Sciences | ||||||
Division name | Department of General Thoracic Surgery | ||||||
Zip code | |||||||
Address | 8-35-1, Sakuragaoka, Kagoshima city, Japan | ||||||
TEL | 099-275-6490 | ||||||
Homepage URL | |||||||
nagatosh@m2.kufm.kagoshima-u.ac.jp |
Sponsor | |
Institute | Kagoshima University |
Institute | |
Department |
Funding Source | |
Organization | Ono Pharmaceutical Co.,Ltd
Bristol-Myers Squibb |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
Organization | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Date analysis concluded |
Other | |
Other related information | observational study
study duration:22/Feb/2017-31/Dec/2022 |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029929 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |