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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023276
Receipt No. R000026649
Scientific Title Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3) as immunotherapy for patients with recurrent/metastatic lung cancer
Date of disclosure of the study information 2016/09/01
Last modified on 2019/07/17

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Basic information
Public title Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3) as immunotherapy for patients with recurrent/metastatic lung cancer
Acronym Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3)
Scientific Title Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3) as immunotherapy for patients with recurrent/metastatic lung cancer
Scientific Title:Acronym Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3)
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate safety on immunotherapy using CpG-ODN(K3) in patient with lung cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Assessment of safety
Key secondary outcomes Progression-free survival
Assessment of specific immune response
Adverse event

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 CpG-ODN(K3)
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically proven lung cancer
2) Non-small cell lung cancer: Clinical stage III, IV, or postoperative recurrence
Small cell lung cancer: Clinical stage II, III, IV
3) Age from 20 to 79 years
4) ECOG performance status of 0 or 1
5) Previously treated, one platinum doublet regimen
6) Response criteria of platinum doublet chemotherapy achieved more than and equal to SD
A mesurable lesion is not required
7) Within 4 months after start of last cycle of platinum doublet chemotherapy
8) Recover from hematological toxicity
9) Adequate function of major organs
10) Written informed consent
Key exclusion criteria 1) Synchronous or metachronous malignancies
2) Symptomatic brain metastasis
3) Massive pleural effusion required for tube drainage
4) Infectious disease requiring systemic treatment
5) Positive test for hepatitis B virus antigen or hepatitis C virus or human immunodeficiency virus
6) History of unstable angina or myocardial infarction
7) Interstitial pneumonia on chest CT
8) History of antiphospholipid antibody syndrome
9) Subjects with active, known or suspected autoimmune disease
10) Current use of aspirin, or anticlotting drug or thrombolytic agent
11) Receiving continuous systemic corticosteroid treatment
12) Pregnant status or lactation
13) Severe psychological disorder
14) Other ineligible status judged by medical oncologist
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sumiyuki Nishida
Organization Osaka University Graduate School of Medicine
Division name Department of Respiratory Medicine and Clinical Immunology
Zip code
Address 2-2,Yamada-oka,Suita,Osaka, Japan
TEL 06-6879-3831
Email sumiyuki-n@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sumiyuki Nishida
Organization Osaka University Graduate School of Medicine
Division name Department of Respiratory Medicine and Clinical Immunology
Zip code
Address 2-2,Yamada-oka,Suita,Osaka, Japan
TEL 06-6879-3831
Homepage URL http://www.imed3.med.osaka-u.ac.jp/c-research/cr-resp11.html
Email sumiyuki-n@imed3.med.osaka-u.ac.jp

Sponsor
Institute Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization The Ministry of Health Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor National Institutes of Biomedical Innovation,Health and Nutrition
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 大阪大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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 11 Day
Date of IRB
2016 Year 10 Month 04 Day
Anticipated trial start date
2016 Year 10 Month 04 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 21 Day
Last modified on
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026649

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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