UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study evaluating abscopal effect of nivolumab in combination with local radiotherapy in patients with pretreated metastatic non-small cell lung cancer
Title of the study (Brief title)	A phase II study evaluating abscopal effect of nivolumab in combination with local radiotherapy in patients with pretreated metastatic non-small cell lung cancer
Region	Japan

Condition
Condition	Non-small cell Lung Cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate immune-mediated abscopal effect of nivolumab in combination with local radiotherapy
Basic objectives2	Others
Basic objectives -Others	To evaluate safety and efficacy, and to explore the predictive biomarker of abscopal effect of nivolumab by blood samples.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate outside the radiation field
Key secondary outcomes	toxicity, overall survival, progression free survival, survival time related to abscopal effect, disease control rate, abscopal response rate at 4/8 weeks after the complition of radiotherapy, immunological analysis using blood samples

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Nivolumab is given at 3 mg/kg intravenously every 2 weeks, and local radiotherapy is performed within 7 days after the previous administration of nivolumab. The timing of the blood sample collection is as follows; before and after radiotherapy, at the point of observing abscopal effect, and at disease progression.
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) Stage IV or recurrent diseases without any indications for operation and radical radiotherapy (3) At least one measurable lesions except lung field and suitable for palliative radiotherapy (4) At least one measurable lesions except radiation site (RECIST ver1.1) (5) Patients who have stable or progression disease (determined by at least two consecutive CT scans at 6-week intervals) after 8 weeks or more of nivolumab treatment (6) Aged 20 or more (7) ECOG Performance status of 0-2 (8) Adequate organ function within 2 weeks before study enrolment (9) estimated life expectancy of at least 3 months (10) Written informed consent
Key exclusion criteria	(1) Active double cancer(except for some early or cured cancer as followe:carcino ma in situ, mucosal cancer, stage I prostate, breast, or laryngeal cancer) (2) History of pericardial effusion, pleural effusion, and ascites which drainage treatment is needed (3) patients with clinically disease progression, such as obvious PS deterioration by nivolumab administration (4) radiation field includes the lung (5) Positive serum HBs antigen (6) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis (7) Patients with a clinically severe complication (8) History of severe drug allergy (9) women who are or may be pregnant or in lactatoin (10) patients judged to be unsuitable for this study by investigators
Target sample size	17

Research contact person
Name of lead principal investigator	Atsushi Kumanogoh
Organization	Osaka University Medical School
Division name	Department of Respiratory, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine
Address	2-2 Yamada-oka, Suita, Osaka
TEL	+81-6-6879-3830
Email	kumanogo@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person	Takayuki Shiroyama
Organization	Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Division name	Department of Thoracic Malignancy
Address	3-7-1 Habikino, Habikino City
TEL	+81-72-957-2121
Homepage URL
Email	takayuki.s12@hotmail.co.jp

Sponsor
Institute	Department of Respiratory, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	ONO PHARMACEUTICAL CO., LTD. Bristol-Myers Squibb.
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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 07 Month 10 Day
Anticipated trial start date	2016 Year 09 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	2016 Year 08 Month 30 Day
Last modified on	2018 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027460