UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023646
Receipt No. R000026587
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.
Date of disclosure of the study information 2016/08/16
Last modified on 2019/08/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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/ctr_e/ctr_view.cgi?recptno=R000026587

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.