UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023276
Receipt number 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 2023/07/02 15:38:25

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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 Sumiyuki
Middle name
Last name Nishida

Organization

Osaka University Graduate School of Medicine

Division name

Department of Respiratory Medicine and Clinical Immunology

Zip code

565-0871

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 Sumiyuki
Middle name
Last name Nishida

Organization

Osaka University Graduate School of Medicine

Division name

Department of Respiratory Medicine and Clinical Immunology

Zip code

565-0871

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 or person

Institute

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

Institute

Department

Personal name



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

Department of Medical Innovation, Osaka University Hospital

Address

2-2,Yamada-oka,Suita,Osaka, Japan

Tel

06-6210-8289

Email

kida@dmi.med.osaka-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

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

https://pubmed.ncbi.nlm.nih.gov/35799134/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35799134/

Number of participants that the trial has enrolled

9

Results

No DLTs at any dose level.
No serious treatment-related adverse events.
Serum IFN-a2 levels increased in six patients after the third administration of CpG ODN (K3). Serum IFN-g and CXCL10 levels increased in eight patients after the third administration. The percentage of T-bet-expressing CD8+ T cells increased. Both T-bet-expressing effector memory (p = 0.0195) and terminally differentiated effector memory (p = 0.0039) CD8+ T cells significantly increased.
The median PFS was 398 days.

Results date posted

2023 Year 07 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

eight non-small-cell lung cancer; one small-cell lung cancer

Participant flow

CpG ODN (K3) was injected via subcutaneous or intravenous administration on days 1, 8, 15, and 29 (study treatment phase) and then every 4-6 weeks until a maximum of 6 months (compassionate use phase).

Adverse events

In total, 27 systemic adverse events were reported, of which 16 (59.3%) were determined to be treatment-related adverse events(TrAEs). All adverse events were of grade 1 or 2.

Outcome measures

The primary endpoint was the proportion of dose-limiting toxicities at each dose level. Secondary endpoints included safety profile, an immune response, including dynamic changes in immune cell and cytokine production, and progression-free survival.

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

2023 Year 07 Month 02 Day



Link to view the page

Value
https://center6.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