UMIN-CTR Clinical Trial

Public title

Phase I/II clinical study of WT4869 peptide-based immunotherapy in patients with completely resected stage IA with vascular invasion, stage IB and stage II non-small cell lung cancer with WT1 antigen positive.

Acronym

Phase I/II clinical study of WT4869 peptide-based immunotherapy in patients with completely resected stage IA with vascular invasion, stage IB/II NSCLC with WT1 antigen positive.

Scientific Title

Phase I/II clinical study of WT4869 peptide-based immunotherapy in patients with completely resected stage IA with vascular invasion, stage IB and stage II non-small cell lung cancer with WT1 antigen positive.

Scientific Title:Acronym

Phase I/II clinical study of WT4869 peptide-based immunotherapy in patients with completely resected stage IA with vascular invasion, stage IB/II NSCLC with WT1 antigen positive.

Region

Japan

Condition

Completely resected NSCLC, stage IA with vascular invasion and stage IB/II with WT1 antigen positive.

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

<Phase I portion>
To assess the recommended dose of WT4869.
<Phase II portion>
To assess the efficacy and safety with recommended dose of WT4869 compared to placebo.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II

Primary outcomes

<Phase I portion>
Ratio of dose-limiting toxicity
Estimate of the maximum tolerated dose
Ratio of adverse events
<Phase II portion>
Ratio of 2-years relapse-free survival

Key secondary outcomes

<Phase I portion>
Relapse-free survival (RFS)
Overall survival (OS)
Ratio of the patients who completed study treatment
Type of recurrence
WT1-antigen specific immune responses
Non-immunological monitoring
<Phase II portion>
Overall survival (OS)
Ratio of the patients who completed study treatment
Type of recurrence
WT1-antigen specific immune responses
Non-immunological monitoring
Ratio of adverse events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

Concealment

Central registration

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

<Phase I portion>WT4869 3 mg will be administered 5 times every week, followed by 4 times every 2 weeks, and 10 times every 4 weeks.

Interventions/Control_2

<Phase I portion>WT4869 6 mg will be administered 5 times every week, followed by 4 times every 2 weeks, and 10 times every 4 weeks.

Interventions/Control_3

<Phase II portion>Recommended dose of WT4869 will be administered 5 times every week, followed by 4 times every 2 weeks, and 10 times every 4 weeks.

Interventions/Control_4

<Phase II portion>Placebo will be administered 5 times every week, followed by 4 times every 2 weeks, and 10 times every 4 weeks.

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 confirmed non-small cell lung cancer with pathologically.
2. The pathological stage is IA with vascular invasion, IB or II.(UICC ver.7)
Patients who are intolerant to standard therapy or refuse standard therapy.
3. Tumor cells are judged WT1 antigen positive by immunohistochemistry.
4. Patients with HLA-A*24:02 positive.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status is 0 or 1.
6. The level of surgical resection is higher than lobectomy.
7. ND2a or higher level lymph node dissection or selective lymph node dissection has been conducted.
8. Patients who is pathologically confirmed complete resection.
9. Trial treatment can be started within 56 days after resection.
10.No other treatments except surgery have been carried out for lung cancer.
11.Patients should be 20 years or older at informed consent.
12.Functions of major organs are maintained, satisfying the following conditions.
1) Neutrophil count >= 1,500/uL
2) Platelet count >= 75,000 /uL
3) Hemoglobin concentration >= 10.0 g/dL
4) Serum creatinine <= 1.5xULN
5) Total bilirubin <= 2.0 mg/dL
6) AST/ALT <= 3.0xULN
7) SpO2 >= 95%
13.Agree to prevent pregnancy from the time of obtaining the first consent to 6 months after the final administration of the study drug.

Key exclusion criteria

1. Patients with residual tumor after surgery.
2. Patients with active double cancer.
3. Patients requiring systemic-immunosuppressive agents or moderate or higher dose of steroid within 28 days before enrollment.
4. Patients had a blood transfusion or administered hematopoietic factor formulation within 14 days before enrollment.
5. Patients administered the other study drug or investigational product within 28 days before enrollment.
6. Patients with history of WT1 peptide administration.
7. Patients with HIV antibody, HBs antigen, HCV antibody positive.
8. Patients with MDS, MDS/MPD, MPD.
9. Patients with pulmonary fibrosis or interstitial pneumonitis.
10.Patients with severe complication.
11.Patients with history of allergy for oil formulation and severe drug hypersensitivity.
12.Pregnant or lactating women or women for childbearing potential, and men who want to get partner pregnant.
13.Patients with psychosis.
14.Inadequate physical condition, as diagnosed by the primary physician.

Target sample size

237

Name of lead principal investigator

1st name
Middle name
Last name	Haruo Sugiyama MD

Organization

Osaka University Graduate School of Medicine

Division name

Department of Functional Diagnosis

Zip code

Address

1-7, Yamada-oka, Suita City, Osaka , Japan

TEL

06-6879-2593

Email

sugiyama@sahs.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroshi Miyamoto

Organization

Secretariat of clinical trial coordinating committee

Division name

(none)

Zip code

Address

Chiyoda-BLDG east, 2-9-4, Higashitenma, Kita-ku, Osaka 530-0044 Japan

TEL

06-6358-7110

Homepage URL

Email

wt4869_jimukyoku@fiverings.co.jp

Institute

Osaka University Graduate School of Medicine, Department of Functional Diagnosis

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

02

Month

13

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

Terminated

Date of protocol fixation

2012

Year

11

Month

26

Day

Date of IRB

Anticipated trial start date

2013

Year

02

Month

20

Day

Last follow-up date

2015

Year

07

Month

06

Day

Date of closure to data entry

2015

Year

08

Month

31

Day

Date trial data considered complete

2015

Year

08

Month

31

Day

Date analysis concluded

Other related information

Registered date

2013

Year

02

Month

13

Day

Last modified on

2015

Year

07

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011740