UMIN-CTR Clinical Trial

Basic information
Public 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
Acronym	Prospective study of the nivolumab effect with respect to single nucleotide polymorphism of immune related genes
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
Scientific Title:Acronym	Prospective study of the nivolumab effect with respect to single nucleotide polymorphism of immune related genes
Region	Japan

Condition
Condition	Non-small cell lung carcinoma
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To determine the efficacy of nivolumab, evaluate treatment response with respect to immune-related gene SNPs among patients with NSCLC.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression free survival after administration of nivolumab with respect to immune-related gene SNPs.
Key secondary outcomes	Immune-related adverse events after administration of nivolumab with respect to immune-related gene SNPs.

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
Interventions/Control_1
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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.
Key exclusion criteria	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.
Target sample size	112

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Ozasa
Organization	Kyoto University
Division name	Department of Respiratory Medicine
Zip code	606-8507
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL	075-751-3830
Email	ozahiro@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Nomizo
Organization	Kyoto University
Division name	Department of Respiratory Medicine
Zip code	606-8507
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL	075-751-3830
Homepage URL	http://kukonai.com/
Email	gnomizo@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	ONO PHARMACEUTICAL CO., LTD. Bristol-Myers Squibb K.K.
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	Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
Tel	075-751-3830
Email	ozahiro@kuhp.kyoto-u.ac.jp

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	京都大学医学部附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 17 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	Preinitiation
Date of protocol fixation	2018 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2023 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a prospective observational study to investigate the association between immune-related gene polymorphism and nivolumab treatment in patients with NSCLC.

Management information
Registered date	2018 Year 07 Month 17 Day
Last modified on	2019 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038092