UMIN-CTR Clinical Trial

Public title

Phase II study of S-588410 as maintenance monotherapy after adjuvant chemotherapy in patients with completely resected non-small- cell lung cancer

Acronym

Phase II study of S-588410 after adjuvant chemotherapy for completely resected non-small- cell lung cancer

Scientific Title

Phase II study of S-588410 as maintenance monotherapy after adjuvant chemotherapy in patients with completely resected non-small- cell lung cancer

Scientific Title:Acronym

Phase II study of S-588410 after adjuvant chemotherapy for completely resected non-small- cell lung cancer

Region

Japan

Condition

Non-small-cell lung cancer

Classification by specialty

Pneumology

Chest surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To evaluate the efficacy of S-588410 in relapse-free survival time by comparison with the placebo control.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

Relapse-free Survival Time as a Measure of Efficacy by Comparison with Placebo Control.

Key secondary outcomes

1. Relapse-free Survival Rate at 1 and 2 Years after Randomization as a Measure of Efficacy, by Comparison with Placebo Control.
2. Association between Relapse-free Survival Time and Induction of Cytotoxic T Lymphocytes Specific for Peptides.
3. Overall Survival Time as a Measure of Efficacy by Comparison with Placebo Control.
4. Overall Survival Rate at 1 and 2 Years after Randomization as a Measure of Efficacy, by Comparison with Placebo Control.
5. Grade and Incidence of Adverse Events as a Measure of Safety and Tolerability.
6. Association between Overall Survival Time as a Measure of Efficacy and Gene Variation detected by Genomics Methods in Lymphocytes as a Predictive Biomarker .

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Placebo-controlled, randomized, double-blind study: Patients with HLA-A*24:02 are randomly divided into two groups. In case of S-588410.

Interventions/Control_2

Placebo-controlled, randomized, double-blind study: Patients with HLA-A*24:02 are randomly divided into two groups. In case of Placebo.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who received platinum-based adjuvant chemotherapy after the complete resection of lung cancer.
2. Pathologically determined non-small-cell lung cancer excepting the large cell neuroendocrine carcinoma and mixed type.
3. Patients with HLA-A*24:02.
4. Neither recurrence nor metastasis of non-small-cell lung cancer demonstrated by imaging tests within 6 weeks prior to the registration.
5. Possible to receive S-588410 within 12 weeks after the last adjuvant chemotherapy.
6. ECOG performance status 0 or 1 within 2 weeks prior to the registration.
7. Age over 20 years at time of consent acquisition.
8. The written informed consent provided by the patient.

Key exclusion criteria

1. Other malignant diseases requiring treatment, excepting the cured cancer in-situ.
2. Concurrent treatment with anticancer drug, steroids, immunosuppressive agent, radiotherapy, immunotherapy, hyperthermia, or surgery.
3. Active and uncontrolled infectious disease.
4. Severe hepatic dysfunction, kidney dysfunction, cardiac disease, pulmonary disease, hematological disorder, or metabolic disease.
5. Coronary artery stenting within 6 months prior to registration.
6. Autoimmune disease.
7. HIV infection.
8. Registration within 4 weeks after the last adjuvant chemotherapy.
9. Laboratory values defined in the protocol within 2 weeks prior to registration.
10. Residual uncontrolled adverse events by adjuvant chemotherapy.
11. Eosinophilia within 28 days prior to registration. Past or active eosinophilic pneumonia or interstitial pneumonitis.
12. Past history of severe allergic reaction against drug, vaccine and biological agents.
13. Female patient in nursing or pregnancy.
14. Refusal of pregnancy conception.
15. Treated with the same peptide vaccines as S-588410.
16. Treated with another investigational drug within 28 days prior to registration or the period of 5 times of the drug half-life.
17. Decision of non-enrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Yataro Daigo

Organization

Institute of Medical Science, The University of Tokyo

Division name

Center for Antibody and Vaccine Therapy, Research Hospital

Zip code

Address

4-6-1 Shirokanedai, Minato-ku, Tokyo

TEL

03-5449-8111

Email

dctsm@ims.u-tokyo.ac.jp

Name of contact person

1st name
Middle name
Last name	Center for Translational Research

Organization

Institute of Medical Science, The University of Tokyo

Division name

Center for Translational Research, Research Hospital

Zip code

Address

4-6-1 Shirokanedai, Minato-ku, Tokyo

TEL

03-5449-5462

Homepage URL

Email

dctsm@ims.u-tokyo.ac.jp

Institute

Research Hospital, Institute of Medical Science, The University of Tokyo

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development
Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Kanagawa Cancer Center
National Cancer Center Hospital East
Shiga University of Medical Science Hospital
Fukushima Medical University Hospital
Hokkaido University Hospital
Shionogi & Co., Ltd.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

NCT02410369

Org. issuing International ID_1

U.S. NIH

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京大学医科学研究所附属病院（東京都）、神奈川県立がんセンター（神奈川県）、国立がん研究センター東病院（千葉県）、滋賀医科大学医学部附属病院（滋賀県）、福島県立医科大学附属病院（福島県）、北海道大学病院（北海道）

Date of disclosure of the study information

2015

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2014

Year

11

Month

28

Day

Date of IRB

Anticipated trial start date

2015

Year

03

Month

31

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

03

Month

31

Day

Last modified on

2017

Year

12

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019356