UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023646 |
|---|---|
| Receipt number | 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 16:24:11 |
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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
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
urata@hp.pref.hyogo.jp
Sponsor or person
Institute
HANSHIN cancer study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026587
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