UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I trial of a treatment of nivolumab combined with stereotactic body radiotherapy for patients with multiple metastatic non-small cell lung cancer.
Title of the study (Brief title)	NIVOSTLUC-1
Region	Japan

Condition
Condition	non-small cell lung cancer with two or more lesions including at least lung or pluera
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the safety of a treatment of Nivolumab combined with stereotactic body radiotherapy for thoracic lesion in patients with advanced non-small cell lung cancer with two or more lesions including at least lung or pluera
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	The ratio of cases with grade four/five or aggravation of two or more toxicity grade within 24 weeks after the start of therapy.
Key secondary outcomes	The reduction ratio in size of irradiated lesions and the non-irradiated lesion at 24 weeks after start of treatment. The change of the tumor marker level as of 24 weeks after start of treatment and stereotactic body radiotherapy. The expression ratio of PD-L1 in the tumor before the start of treatment. The ratio of case with one or two aggravation of toxicity grade within 24 weeks after the start of therapy.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Total 12 courses of Nivolumab(3 mg/kg,by 2weeks). Performing stereotactic body radiation therapy (more than 5 Gy/fraction(total biological effective dose of 40-55Gy within 2weeks) for lung or a pleura lesion at the third course.
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)Cytologically or histologically confirmed non-small-cell lung cancer 2)At least two measurable lesions including at least one lung or thoracic lesion. 3)Radical radiotherapy not applicable 4)Aged 20 or more 5)ECOG Performance status of 0-2 6)Judgement by Radiation-oncologist for indication and safely of irradiation 7)Satisfication of the following criteria in the latest labo data within 7 days of the registration:1.WBC=3000 per mm3 or more,2.Hb=9.0g per dl or more, 3.PLT=100000 per mm3 or more, 4.Serum Creatinine=1.5mg per dl or less, 5.Total bililubine=1.5mg per dl or less, 6.GOT(AST)=100IU per L or less, 7.GPT(ALT)=100IU per L or less, 8.SpO2=93% or more(room ai) 8)Written informed consent after enough explanation
Key exclusion criteria	1)Active double cancer(except for some early or cured cancer as followe:carcinoma in situ, mucosal cancer, stage I prostate, breast, or laryngeal cancer) 2)Serious heart disease,uncontrolled diabetes mellitus despite continuing treatment of insulin,cardiac infarction within 6 months before enrollment,uncontrolled hypertension,history of severe infections,watery diarrhea,paresis of intestine,ileus,autoimmune disease,other severe complications 3)Radiographically (chest X-P or CT image) confirmed interstitial pneumonitis or pulmonary fibrosis 4)Severe emphysema, chronic bronchitis, asthma 5)Continuous systemic administration of steroid 6)Severe mental illness 7)women who are or may be pregnant or in lactatoin 8)Unsuitable patients judged by the attending physician or radiation-oncologist(previous irradiation is ignored)
Target sample size	12

Research contact person
Name of lead principal investigator	Hiroshi Onishi
Organization	Faculty of Medicine, University of Yamanashi
Division name	Department of Radiology
Address	1110, Shimokato, Chuo, Yamanashi
TEL	055-273-1111
Email	honishi@yamanashi.ac.jp

Public contact
Name of contact person	Kan Marino
Organization	Faculty of Medicine, University of Yamanashi
Division name	Department of Radiology
Address	1110, Shimokato, Chuo, Yamanashi
TEL	055-273-1111
Homepage URL
Email	marino@yamanashi.ac.jp

Sponsor
Institute	Department of Radiology, University of Yamanashi
Institute
Department

Funding Source
Organization	ONO PHARMACEUTICAL CO., LTD. Bristol-Myers Squibb Company
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	山梨大学医学部附属病院（山梨県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 17 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 08 Month 15 Day
Anticipated trial start date	2016 Year 08 Month 15 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 08 Month 16 Day
Last modified on	2017 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027040