UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the safety of Nivolumab in elderly patients with previously treated non-small cell lung cancer
Title of the study (Brief title)	A study to evaluate the safety of Nivolumab in elderly patients with previously treated non-small cell lung cancer
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the safety of Nivolumab in elderly patients with previously treated non-small cell lung cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	safety
Key secondary outcomes	objective response rate progression free survival disease control rate overall survival

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	Medicine
Interventions/Control_1	Nivolumab
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	75 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1)Age of 75 years old and older than 75 years old 2)Histologically and/or cytologically proven non-small cell lung cancer 3)Clinical stage IIIB without indication of definitive thoracic radiotherapy, stage IV, or postoperative recurrent disease. 4)ECOG performance status 0-2. 5)previously treated with systemic chemotherapy 6)Adequate organ function
Key exclusion criteria	1)Subjects with interstitial lung disease which is detected by chest X-ray 3)Subjects with previous malignancies are excluded unless a complete remission was achieved at least 5 years prior to study entry. 4)Uncontrolled intercurrent illness including symptomatic cardiac arrhythmia, or diabetes, Intestinal obstruction. 5)known or suspected autoimmune disease, or receiving continuous systemic corticosteroid or immunosuppressant treatment. 6)Subjects with symptomatic CNS metastases or symptomatic carcinomatous meningitis. Subjects with asymptomatic CNS metastases, and subjects after 4 weeks from whole brain radiation therapy or 2 weeks from stereotactic brain radiation therapy can be included. 7)Radiation therapy within 4 weeks of the first dose of Nivolumab. 8)Subjects with known infection with HIV or AIDS . Positive test for hepatitis B virus antigen or hepatitis C virus indicating acute or chronic infection. 9)Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 10)Dementia or psychological disorder difficult to participate in this clinical study.
Target sample size	30

Research contact person
Name of lead principal investigator	Fujitaka Kazunori
Organization	Hiroshima University Hospital
Division name	respiratory medicine
Address	1-2-3 Kasumi, Minami-ku, Hiroshima,
TEL	082-257-5555
Email	fujikazu@hiroshima-u.ac.jp

Public contact
Name of contact person	Yamaguchi Kakuhiro
Organization	Hiroshima University Hospital
Division name	respiratory medicine
Address	1-2-3 Kasumi, Minami-ku, Hiroshima,
TEL	082-257-5555
Homepage URL
Email	yamaguchikakuhiro@gmail.com

Sponsor
Institute	Hiroshima University Hospital
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Other
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	広島大学病院（広島県）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 02 Month 17 Day
Anticipated trial start date	2016 Year 02 Month 17 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	2016 Year 02 Month 10 Day
Last modified on	2019 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024206