UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomised phase II trial of personalized peptide vaccination plus "Keppuchikuoto" vs personalized peptide vaccination alone for non small cell lung cancer patients
Title of the study (Brief title)	A randomised phase II trial of peptide vaccination with "keppuchikuoto" for non samll cell lung cancer patients
Region	Japan Asia(except Japan)

Condition
Condition	Unresectable non smaii cell lung cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare the immunological responses and overall survival of personalized peptide vaccination plus Keppuchikuoto with personalized peptide vaccination alone.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Assesment of immunoresponses by mesurement of peptide specific CTL responses by ELISPOT assay
Key secondary outcomes	1.Assesment of immunoresponses by mesurement of peptide specific IgGs 2.Overall survival 3.Safety assesment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Vaccine
Interventions/Control_1	Peptide vaccine plus Keppuchikuoto
Interventions/Control_2	Peptide vaccine
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The subjects must satisfy the following conditions. 1) Cytologically or histologically documented non-small cell carcinoma of the lung that is not for curable therapy. 2) Patients must be at a score level 0-1 of ECOG performance status. 3) Patients must have IgGs reactive to at least two of the candidate peptides restricted to the patient's HLA types. 4) Patients must be positive for HLA-A2,A24,A26,A3,A11,A31 or A33. 5) Patients must be expected to survive more than 3 months. 6) Ptient's laboratory data must satisgy the followings: WBC is more than 2500/mm3 Lymphocyte is more than 900/mm3 Hb is more than 8.0g/dL Platelet is more than 80000/mm3 Serum Creatinine is less than 2 times the ULN Total bilirubin is less than 2 times the ULN 7) Patients must be more 18 year-old 8) Written informed consent must be obtained from patients.
Key exclusion criteria	The following patients must be excluded: 1) Patients with severe underlying diseases / conditions(active and severe infectious diseases, circulatory diseases, respiratory diseases, renal diseases, immunodeficiencies, disturbance of coagulation, et al. Respiratory diseases are pulmonary damage, such as interstitial pneumonia and pneumoconiosis). 2) Active double cancer(synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ(lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 3) Patients with the past history of severe allergic reactions. 4) (Females)Pregnant or nursing patients. Patients desiring future fertility. (Males)Patients who do not sccept contraception from the 1st vaccination until 70 days after the last vaccination. 5) Patients who has taken Keppuchikuoto. 6) Patients who has taken Bevacizumab.(Participation is made possible when four or more weeks have passed from the last medication to an examination opening day.) 7) Patients who are judged inappropriate for entry to this clinical trial by doctors.
Target sample size	60

Research contact person
Name of lead principal investigator	Shigeru Yutani
Organization	Kurume University
Division name	Cancer Vaccine Center
Address	155-1 Kokubu-machi Kurume-city Fukuoka-pref JAPAN, 839-0863
TEL	0942-27-5210
Email	yutani@med.kurume-u.ac.jp

Public contact
Name of contact person	Shigeru Yutani
Organization	Kurume University
Division name	Cancer Vaccine Center
Address	155-1 Kokubu-machi Kurume-city Fukuoka-pref JAPAN, 839-0863
TEL	0942-27-5210
Homepage URL	http://www.med.kurume-u.ac.jp/med/cvc/
Email	yutani@med.kurume-u.ac.jp

Sponsor
Institute	Kurume Unversity Cancer Vaccine Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	久留米大学がんワクチンセンター（福岡県）、内藤病院（福岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 26 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 08 Month 27 Day
Anticipated trial start date	2014 Year 09 Month 26 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 02 Month 28 Day
Date analysis concluded	2020 Year 03 Month 31 Day

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

Management information
Registered date	2014 Year 09 Month 16 Day
Last modified on	2017 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017518