UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of evaluation to the predictive biomarker of Nivolumab by tumor tissue specimen and neighboring bronchoaveolar lavage fluid (BALF) and Blood
Title of the study (Brief title)	Evaluation to the predictive biomarker of Nivolumab by Tumor tissue, BALF, and Blood
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	YES

Objectives
Narrative objectives1	We will reveal predictive biomarker for nivolmab
Basic objectives2	Others
Basic objectives -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
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We will reveal predictive biomarker for nivolmab by evaluate the tumor tissue, BALF, and blood collection.
Key secondary outcomes	Progression free Survival, Overall Survival, Response Rate, Disease Control Rate, safety

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	Maneuver
Interventions/Control_1	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
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 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
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 (9)The case that be judged as the inappropriate object of the this examination
Target sample size	20

Research contact person
Name of lead principal investigator	Atsushi Kumanogoh
Organization	Osaka University Medical School
Division name	Respiratory Medicine, Allergy and Rheumatic Diseases Osaka University Graduate School of Medicine
Address	2-2 Yamada-oka, Suita, Osaka
TEL	+81-(0)6-6879-3830
Email	kumanogo@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person	Motohiro Tamiya
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Thoracic Oncology
Address	1-3-3 Nakamichi, Higashinari-ku, Osaka, Osaka
TEL	+81-(0)6-6972-1181
Homepage URL
Email	moto19781205@yahoo.co.jp

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

Funding Source
Organization	ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	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）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 19 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 29 Day
Last modified on	2019 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027442