UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of Nivolumab re-challenge therapy after VEGF inhibitor therapy in patients with advanced non-small cell lung cancer. Gunma-Ibaraki-Fukushima-Tochigi (GIFT) group study
Acronym	Nivolumab re-challenge therapy after VEGF inhibitor therapy.
Scientific Title	A phase II study of Nivolumab re-challenge therapy after VEGF inhibitor therapy in patients with advanced non-small cell lung cancer. Gunma-Ibaraki-Fukushima-Tochigi (GIFT) group study
Scientific Title:Acronym	Nivolumab re-challenge therapy after VEGF inhibitor therapy.
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Response of Nivolumab re-challenge therapy after VEGF inhibitor therapy in patients with advanced non-small cell lung cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Overall response rate
Key secondary outcomes	Progression free survival Over all survival Adverse events Examination of the immunity

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 re-challenge therapy (3mg/kg, every 2 weeks)
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 proven non-squamous non-small cell lung cancer 2)Stage IIIB,stageIV without any indications for radiotherapy 3)Those who were benefit from anti PD-1 antibody therapy such as CR, PR, SD. 4)ECOG performance status 0-1 5)With one or more measurable disease (RECIST ver.1.1) 6)Aged 20<= 7)Adequate organ function 8)Less than two weeks interval after last VEGF inhibitor therapy 9)Written informed concent
Key exclusion criteria	1)Symptomatic brain metastasis 2)Active infections diseases 3)Serious complications 4)Active concomitant cancers 5)Severe adverse events of Nivolumab 6)Pregnancy, breastfeeding or suspected of being pregnant 7)Those judged to be not suitable by the attending physician
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuji Heike
Organization	St. Luke's International Hospital
Division name	Immunotherapy and Cell Therapy Service
Zip code
Address	9-1, Akashi-cho, chuoku, Tokyo, Japan.
TEL	+81-3-3541-5151
Email	heiyuji@luke.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takashi Kasai
Organization	Tochigi Cancer Center
Division name	Department of Medical Oncology,
Zip code
Address	4-9-13
TEL	+81-28-658-5151
Homepage URL
Email	takasai@tochigi-cc.jp

Sponsor
Institute	GIFT group
Institute
Department

Funding Source
Organization	Ono Pharmaceutical Co., Ltd. Bristol-Myers Squibb K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date	2018 Year 01 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 22 Day
Last modified on	2018 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035329

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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