UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of nivolumab following radiation therapy to bone metastases in patients with non-small cell lung cancer
Acronym	RT-Nivo NSCLC phase II
Scientific Title	Phase II trial of nivolumab following radiation therapy to bone metastases in patients with non-small cell lung cancer
Scientific Title:Acronym	RT-Nivo NSCLC phase II
Region	Japan

Condition
Condition	non-small cell lung cancer with bone metastasis
Classification by specialty	Pneumology Hematology and clinical oncology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate antitumor effects of nivolumab following palliative radiation to bone metastases
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Objective response rate
Key secondary outcomes	Progression free survival, overall survival, safety, and tolerability

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	Radiation therapy 20 Gy/5 fractions to bone metastasis, followed by nivolumab 3mg/kg administered 6 to 24 hours after the end of the radiation therapy. Then, nivolumab is given every two weeks until disease progression or stop of the treatment because of toxicity.
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) a histological or cytological diagnosis of non-small cell lung cancer 2) having bone metastasis suitable for palliative radiation therapy which had not been radiated 3) age above 20 years old 4) ECOG performance status of 0-2 5) Prior platinum-containing chemotherapy 6) Adequate organ function as documented by a WBC count of 3,000/microL or higher, hemoglobin of 9.0 g/dL or higher, platelet count of 100,000/microL or higher, serum creatinine of 1.5 mg/dL or lower, hepatic transaminases of 100 IU/L or lower, alanine aminotransferase of 100 IU/L or lower, total serum bilirubin of 1.8 mg/dL or lower, and PaO2 of 70 Torr or higher or SpO2 of 93% or higher at room air 7) having a measurable disease with CT or MRI 8) written informed consent
Key exclusion criteria	1) Positive for epidermal grow factor receptor activating mutation or ALK re-arrangement 2) Active malignancies within 2 years 3) Active infection requiring intravenous systemic therapy or hospital admission 4) A history of interstitial lung disease 5) A history of active, known autoimmune disease. 6) Requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications. 7) Active CNS metastasis 8) Carcinomatous meningitis 9) Positive for HBs antigen or HBV-DNA positive 10) Positive for HCV antibody 11) Pregnant or breast-feeding women 12) Any other patients whom the doctor judged to be unsuitable for this trial
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ikuo Sekine
Organization	University of Tsukuba Hospital
Division name	Department of Medical Oncology
Zip code
Address	Amakubo 2-1-1, Tsukuba-shi, ibaraki
TEL	029-853-3900
Email	isekine@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ikuo Sekine
Organization	University of Tsukuba Hospitgal
Division name	Department of Medical Oncology
Zip code
Address	Amakubo 2-1-1, Tsukuba-shi, ibaraki
TEL	029-853-3900
Homepage URL
Email	isekine@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba Hospital
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	2017 Year 02 Month 01 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	Terminated
Date of protocol fixation	2017 Year 02 Month 01 Day
Date of IRB	2017 Year 03 Month 07 Day
Anticipated trial start date	2017 Year 03 Month 07 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 27 Day
Last modified on	2021 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029747