UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study evaluating immune-priming effect of Nivolumab in combination with palliative radiationtherapy in previously treated patients with non-small cell lung cancer.
Acronym	A phase II study evaluating immune-priming effect of Nivolumab in combination with palliative radiationtherapy in previously treated patients with non-small cell lung cancer. (PRINCIPAL study,HANSHIN 0116)
Scientific Title	A phase II study evaluating immune-priming effect of Nivolumab in combination with palliative radiationtherapy in previously treated patients with non-small cell lung cancer.
Scientific Title:Acronym	A phase II study evaluating immune-priming effect of Nivolumab in combination with palliative radiationtherapy in previously treated patients with non-small cell lung cancer. (PRINCIPAL study,HANSHIN 0116)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate immune-priming effect of Nivolumab in combination with radiationtherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate(extra field of radiation therapy)
Key secondary outcomes	Overall survival, Progression free survival , disease control rate, Toxicity,

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 administered initially at 3 mg/kg by vein every 2 weeks Palliative radiation therapy performed within 10days after first administration of 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	20 years-old <
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1.Over 20 years old 2.Histologically or cytologically proven non-small cell lung cancer (except LCNEC) 3. Stage IIIB, stage IV or recurrent disease after surgery 4. Previously treated with systemic chemotherapy. 4-1 EGFR/ALK negative or unknown patient must receive previously platinum doublet chemotherapy. (over 75years old, monotherapy is allowed) 4-2 EGFR or ALK positive patient must previously receive both olatinum doublet chemotherapy and molecular targeted drug. 5. Patients suitable for palliative radiation therapy 6. ECOG PS 0-2 7.Patients are expected to live over 90days 8. SpO2>=92 or PaO2 >=60mmHg 9. adequate organ function 10. Patients with or without brain metastasis are eligible. 11. Do not need for steroid 12. more than 14 days of interval after pretreatment. 13.Written informed consent
Key exclusion criteria	1.History of severe drug allergy 2.Side effects of previously treatment is existed and disturb safety analysis 3.urrent or previous History of auto immune disease 4.Pulmonary fibrosis detected by chest CT or clinical examination 5.current or previous history of diverticulitis or ulcerative disease of GI 6.History of active double cancer with in 5 years 7.History of pericardial effusion/ pleural effusion/ ascites with treatment needed. 8.Brain metastasis required for radiation therapy. 9.uncontrolled pain due to bone metastasis 10.Current or previous (within the last 180days) history of symptomatic cerebrovascular disease or thromboembolism. 11.Uncontrollable severe cardiovascular disease 12.Uncontrollable diabetes mellitus 13. previous (within the last 14 days) pleurodesis 14.previous (within the last 28 days) operation with systemic anesthesia 15.previous (within the last 56 days) thoracic radiation therapy with over 40Gy. 16.systemic infectious disease require treatment. 17.Active hepatitis type B or typeC 18.Sever side effect caused by previously treated immune checkpoint blockade. 19.History of active psychological disease. 20.History of dementia 21.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Miyako Middle name Last name Satouchi
Organization	Hyogo Cancer Center
Division name	Thoracic Oncology
Zip code	683-8558
Address	13-70 Kitaoji - cho, Akasi-city, Hyogo.
TEL	0789-929-1151
Email	urata@hp.pref.hyogo.jp

Public contact
Name of contact person	1st name Yoshiko Middle name Last name Urata
Organization	Hyogo Cancer Center
Division name	Thoracic Oncology
Zip code	673-8558
Address	13-70 Kitaoji -cho, Akasi-city, Hyogo.
TEL	0789-929-1151
Homepage URL
Email	urata@hp.pref.hyogo.jp

Sponsor
Institute	HANSHIN cancer study group
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	Hanshin Cancer Study Group
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hyogo Cancer Center IRB
Address	13-70 Kitaoji -cho, Akasi-city, Hyogo.
Tel	078-929-1151
Email	rinsyosikenkanri@hyogo-cc.jp

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	兵庫県立がんセンター（兵庫県） 先端医療センター（兵庫県） 神戸大学病院（兵庫県） 大阪府立成人病センター（大阪府） 関西医科大学付属枚方病院（大阪府） 四国がんセンター（愛媛県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 16 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	28
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	No longer recruiting
Date of protocol fixation	2016 Year 03 Month 31 Day
Date of IRB	2016 Year 05 Month 06 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2019 Year 07 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	2016 Year 08 Month 16 Day
Last modified on	2019 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=R000026587