UMIN-CTR Clinical Trial

Basic information
Public title	A study of evaluation to the predictive biomarker of Nivolumab in peripheral blood and pleural effusion.
Acronym	A biomarker study of of Nivolumab in blood and pleural effusion.
Scientific Title	A study of evaluation to the predictive biomarker of Nivolumab in peripheral blood and pleural effusion.
Scientific Title:Acronym	A biomarker study of of Nivolumab in blood and pleural effusion.
Region	Japan

Condition
Condition	previously treated patients with advanced non-small-cell lung cancer
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To reveal predictive biomarker for nivolmab
Basic objectives2	Others
Basic objectives -Others	response rate, progression free survival, overall survival
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	We study biomarkers in peripheral blood and pleural effusion between before and 2-4 week after Nivolumab treatment start.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Collecting pleural effusion and blood before and after Nivolumab treatment
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Histologically or cytologically comfarmed non-small-cell lung cancer 2)Stage VI or recurrent diseases (without any indications for operation and radiotherapy) with pleural effusion that can be taken 3)Have measuarable lesion in lung by using the RECIST ver1.1 (Response Evaluation Criteria In Solid Tumors) criteria. 4)Twenty or more years old at tnetime of imformed consent 5)Eastern Coopperative Oncology Group Perfoemance Status (ECOG PS)0-1 6)Have adequate organ function within 14 days before entry 7)Estimate life expectancy of at least 12 weeks 8)Have signed an informed consent document
Key exclusion criteria	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
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsushi Kumanogoh
Organization	Osaka University Medical School
Division name	Respiratory Medicine, Allergy and Rheu matic Diseases Osaka University Gradu ate School of Medicine
Zip code
Address	2-2 Yamada-oka, Suita, Osaka
TEL	06-6879-3831
Email	kumanogo@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hidekazu Suzuki
Organization	Osaka Habikino Medical Center
Division name	Department of Thoracic oncology
Zip code
Address	3-7-1 Habikino, Habikino-shi, Osaka
TEL	+81-72-957-2121
Homepage URL
Email	suzukih@opho.jp

Sponsor
Institute	Respiratory Medicine, Allergy and Rheu matic Diseases Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	ONO PHARMACEUTICAL CO., LTD. Bristol-Myers Squibb.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2016 Year 08 Month 31 Day

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	Completed
Date of protocol fixation	2016 Year 07 Month 01 Day
Date of IRB	2016 Year 07 Month 19 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 08 Month 31 Day
Last modified on	2022 Year 03 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027498