UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of WT1-W10 peptide vaccine monotherapy for patients with previously-treated advanced Non-Small Cell Lung Cancer
Title of the study (Brief title)	A phase II study of WT1 vaccine for previously-treated NSCLC
Region	Japan

Condition
Condition	Non-Small Cell Lung Cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
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

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	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

Eligibility
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

Research contact person
Name of lead principal investigator	Akihito Yokoyama
Organization	Kochi University, School of Medicine
Division name	Department of Hematology and Respiratory Medicine
Address	Kohasu, Okocho, Nankoku city, Kochi 783-8505, Japan
TEL	088-880-2345
Email	im25@kochi-u.ac.jp

Public contact
Name of contact person	Tetsuya Kubota
Organization	Kochi University, School of Medicine
Division name	Department of Hematology and Respiratory Medicine
Address	Kohasu, Okocho, Nankoku city, Kochi 783-8505, Japan
TEL	088-880-2345
Homepage URL
Email	im25@kochi-u.ac.jp

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

Funding Source
Organization	NEC Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	高知大学医学部附属病院 (高知)

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 02 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 04 Month 17 Day
Last modified on	2017 Year 12 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016003