UMIN-CTR Clinical Trial

Public title

A phase II study of WT1-W10 peptide vaccine monotherapy for patients with previously-treated advanced Non-Small Cell Lung Cancer

Acronym

A phase II study of WT1 vaccine for previously-treated NSCLC

Scientific Title

A phase II study of WT1-W10 peptide vaccine monotherapy for patients with previously-treated advanced Non-Small Cell Lung Cancer

Scientific Title:Acronym

A phase II study of WT1 vaccine for previously-treated NSCLC

Region

Japan

Condition

Non-Small Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Objective of this study is to investigate efficacy and safety of WT1-W10 peptide vaccine monotherapy for previously-treated or relapsed non-small cell lung cancer patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

response rate (RR)

Key secondary outcomes

disease control rate (DCR), progression free survival (PFS), overall survival (OS), evaluation of safety and specific immune response

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

immunotherapy of WT1-W10 peptide vaccine

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
2) Patients whose cancer cells express WT1, or patients with undetermined WT1 status due to tissue unavailability.
3) Patients who have previously been treated with at least one chemotherapy regimen. Postoperative oral UFT therapy does not mean previous chemotherapy regimen.
4) Patients who have one of the following HLA types: A*24:02, A*02:01, A*02:06, A*02:07.
5) Performance status (ECOG) 0-2.
6) Patients who has at least one or more measurable lesion(s) by RECIST.
7) Sufficient function of main organ and bone marrow filling the following criteria:
Neutrophil counts, 1,500/mm3 or over.
Platelets, 100,000/mm3 or over.
AST and ALT, x 2.5 of upper limit of normal (ULN) or less.
Total bilirubin, 1.5 mg/dl or less.
Serum creatinin, x 1.5 of ULN or less.
SpO2 90% or above (while breathing ambient air).
8) Patients who are considered to survive for more than 6 months.
9) Patients providing written informed consent.

Key exclusion criteria

1) Patients with active concomitant malignancy.
2) Patients with active and severe infection, requiring intravenous antibiotics and/or anti fungal agents.
3) Patients with active lung disease such as idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, or drug-induced pneumonitis, and considered as inappropriate for the study by the physicians.
4) Patients with uncontrollable complications (e.g. uncontrollable heart disease, uncontrollable effusion and/or pericardial effusion, symptomatic brain metastasis, severe arrhythmia, and so on).
5) Pregnancy or lactation.
6) Patients with mental disorder, and considered as inappropriate for the study by the physicians.
7) Inappropriate patients for this study judged by the physicians.

Target sample size

29

Name of lead principal investigator

1st name
Middle name
Last name	Akihito Yokoyama

Organization

Kochi University, School of Medicine

Division name

Department of Hematology and Respiratory Medicine

Zip code

Address

Kohasu, Okocho, Nankoku city, Kochi 783-8505, Japan

TEL

088-880-2345

Email

im25@kochi-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Tetsuya Kubota

Organization

Kochi University, School of Medicine

Division name

Department of Hematology and Respiratory Medicine

Zip code

Address

Kohasu, Okocho, Nankoku city, Kochi 783-8505, Japan

TEL

088-880-2345

Homepage URL

Email

im25@kochi-u.ac.jp

Institute

Kochi University, School of Medicine, Department of Hematology and Resporatory Medicine

Institute

Department

Personal name

Organization

NEC Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

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

高知大学医学部附属病院 (高知)

Date of disclosure of the study information

2014

Year

05

Month

01

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

2014

Year

02

Month

17

Day

Date of IRB

Anticipated trial start date

2014

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

04

Month

17

Day

Last modified on

2017

Year

12

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016003