UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021136 |
|---|---|
| Receipt number | R000024157 |
| Scientific Title | A phase III study of Platinum doublet chemotherapy with or without Nivolumab for the patients with chemo-naive, advanced non-small cell lung cancer (WJOG8615L) |
| Date of disclosure of the study information | 2016/02/22 |
| Last modified on | 2016/08/16 16:25:15 |
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Basic information
Public title
A phase III study of Platinum doublet chemotherapy with or without Nivolumab for the patients with chemo-naive, advanced non-small cell lung cancer (WJOG8615L)
Acronym
A phase III study of Platinum doublet chemotherapy +/- Nivolumab in advanced non-small cell lung cancer (WJOG8615L)
Scientific Title
A phase III study of Platinum doublet chemotherapy with or without Nivolumab for the patients with chemo-naive, advanced non-small cell lung cancer (WJOG8615L)
Scientific Title:Acronym
A phase III study of Platinum doublet chemotherapy +/- Nivolumab in advanced non-small cell lung cancer (WJOG8615L)
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate whether platinum doublet chemotherapy plus nivolumab prolong PFS and OS compared with platinum doublet chemotherapy in chemo-naive advanced NSCLC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Overall survival and progression-free survival
Key secondary outcomes
Overall response rate, survival rate at two years, and safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Platinum doublet chemotherapy (cisplatin 75mg/m2, or carbploatin (AUC 6)+pemetrexed 500mg/m2, cisplatin 75mg/m2+gemcitabine 1000mg/m2, carboplatin (AUC 6)+paclitaxel 200mg/m2), 4 courses, every 3weeks
Interventions/Control_2
Platinum doublet chemotherapy (same as described above)+ nivolumab 3mg/kg, every 3 weeks
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Pathologically proven, advanced NSCLC
2. Chemotherapy-naive
3. With evaluable lesion per RECIST ver 1.1
4. Tumor specimen can be submitted to evaluate PD-L1 IHC
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Key exclusion criteria
1. Subjects with active, known or suspected autoimmune disease.
2. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
3. Subjects with interstitial lung disease
4. Positive test for hepatitis B virus antigen or hepatitis C virus indicating acute or chronic infection
Target sample size
530
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Akamatsu |
Organization
Wakayama Medical University
Division name
Third Department of Internal Medicine
Zip code
Address
Kimiidera 811-1, Wakayama-city, Wakayama, Japan
TEL
073-441-0619
h-akamat@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd
Bristol-Myers K.K
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 22 | 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
| 2016 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 22 | Day |
Last modified on
| 2016 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024157
