UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023131 |
|---|---|
| Receipt number | R000026471 |
| Scientific Title | An Observational Study to Predict the Efficacy and Optimal Duration of Treatment with Nivolumab in Patients with Previously Treated Advanced or Recurrent Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2016/07/12 |
| Last modified on | 2024/01/16 16:24:55 |
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Basic information
Public title
An Observational Study to Predict the Efficacy and Optimal Duration of Treatment with Nivolumab in Patients with Previously Treated Advanced or Recurrent Non-Small Cell Lung Cancer
Acronym
New Epoch Study
Scientific Title
An Observational Study to Predict the Efficacy and Optimal Duration of Treatment with Nivolumab in Patients with Previously Treated Advanced or Recurrent Non-Small Cell Lung Cancer
Scientific Title:Acronym
New Epoch Study
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Adult |
| Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore clinical predictors for the efficacy of nivolumab. To evaluate the relationships between early factors after therapy initiation and response (disease control) or adverse events (AEs; e.g., interstitial pneumonia, type 1 diabetes mellitus and hypothyroidism) in patients with advanced lung cancer.
Basic objectives2
Others
Basic objectives -Others
QoL assessment
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Disease control rate at Month 6
Key secondary outcomes
1)Response rate (RR)
2)Correlation with each predictor for 2-year survival
3)Overall survival (OS), 1- and 2-year survival rates
4)Progression free survival (PFS) according to the RECIST
5)Clinical progression-free survival (cPFS)
6)Incidence of AEs such as skin disorder, diarrhoea, thyroid function and pulmonary toxicity
7)QOL score (EQ-5D-5L) at each evaluation time point
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with cytologically or histologically confirmed NSCLC
2)Patients who are not indicated for radical therapy, previously received at least one regimen of chemotherapy, and are planned to receive nivolumab as the second or third-line treatment in clinical practice
3)Patients aged 20 years or older who provided informed consent for this study
4)Patients with evaluable lesions according to the RECIST ver1.1
Key exclusion criteria
1)Patients with EGFR mutations (Exon 19 deletion, L858R, T790M or other) and ALK fusion genes
2)Patients who are incapable of completing the EQ-5D-5L questionnaire
3)Patients who are on corticosteroid equivalent to/above 5 mg of prednisolone
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Kunitoh |
Organization
Japanese Red Cross Medical Center
Division name
Department of Medical Oncology
Zip code
Address
4-1-22 Hiroo, Shibuya-ku, Tokyo
TEL
03-3400-1311
kunito_hideo@med.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamao |
Organization
Public Health Reseach Foundation
Division name
Comprehensive Support Project for Oncology Research
Zip code
Address
1-1-7 Nishi-waseda,Shinjuku-ku,Tokyo
TEL
03-5287-2636
Homepage URL
cspor-lc04@csp.or.jp
Sponsor or person
Institute
PHRF
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co.Ltd
Bristol-Myers Squibb KK
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
NO
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
KKR札幌医療センター
北海道大学大学院医学研究科
岩手県立中央病院
東北大学病院
秋田赤十字病院
山形県立中央病院
慈山会医学研究所付属 坪井病院
栃木県立がんセンター
群馬県立がんセンター
国立がん研究センター東病院
NTT東日本関東病院
がん感染症センター都立駒込病院
杏林大学医学部付属病院
国立がん研究センター中央病院
日本赤十字医療センター
三井記念病院
国立国際医療研究センター
北里大学病院
横浜市立市民病院
新潟県立がんセンター新潟病院
大阪医科大学附属病院
岡山赤十字病院
倉敷中央病院
福山市民病院
独立行政法人国立病院機構沖縄病院
昭和大学病院
帝京大学医学部附属病院
兵庫県立尼崎総合医療センター
国立病院機構東京病院
東京医科大学病院
日本医科大学付属病院
長崎大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 12 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients who has given consent to participate in the study during from 2016/07/01 to 2018/12/31
Management information
Registered date
| 2016 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026471
