UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039784 |
|---|---|
| Receipt number | R000045369 |
| Scientific Title | Nivolumab plus Ipilimumab versus existing immunotherapies in patients with PD-L1-positive advanced non-small cell lung cancer: a systematic review and network meta-analysis. |
| Date of disclosure of the study information | 2020/03/14 |
| Last modified on | 2020/06/04 15:53:32 |
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Basic information
Public title
Nivolumab plus Ipilimumab versus existing immunotherapies in patients with PD-L1-positive advanced non-small cell lung cancer: a systematic review and network meta-analysis.
Acronym
Nivolumab plus Ipilimumab for PD-L1-positive advanced non-small cell lung cancer
Scientific Title
Nivolumab plus Ipilimumab versus existing immunotherapies in patients with PD-L1-positive advanced non-small cell lung cancer: a systematic review and network meta-analysis.
Scientific Title:Acronym
Nivolumab plus Ipilimumab for PD-L1-positive advanced non-small cell lung cancer
Region
| Japan |
Condition
Condition
PD-L1-positive previously untreated advanced non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of Nivolumab plus Ipilimumab versus existing immunotherapies in patients PD-L1 positive previously untreated advanced non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival(PFS) in patients with PD-L1 expression levels of 1% or over
Key secondary outcomes
Progression free survival(PFS) in patients with PD-L1 expression levels of 50% or over
Overall survival(OS)in patients with PD-L1 expression levels of 1% or over
Overall survival(OS) in patients with PD-L1 expression levels of 50% or over
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Advanced NSCLC with at least one measurable lesion
No previous systemic anticaner treatment
Performance status (PS) range of 0-1
Key exclusion criteria
Patients with EGFR-sensitive mutations wereexcluded in the case of histologically squamous cell carcinoma.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Ando |
Organization
Showa University School of Medicine
Division name
Department of Medicine, Division of Respiratory Medicine and Allergology,
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL
+81-3-3784-8532
koichi-a@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Ando |
Organization
Showa University School of Medicine
Division name
Department of Medicine, Division of Respiratory Medicine and Allergology,
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL
+81337848532
Homepage URL
koichi-a@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Showa University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University School of Medicine
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
Tel
+81337848532
koichi-a@med.showa-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 14 | 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
4011
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
| 2020 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conducted a network mate-analysis (NMA) among Niv+Ipi, pembrolizumab (Pem), pembrolizumab plus platinum based chemotherapy (Pem+CT), Pem monotherapy (Pem), nivolumab monotherapy (Niv), and platinum based chemotherapy (CT) using Bayesian model with non-informative prior distribution.
Management information
Registered date
| 2020 | Year | 03 | Month | 12 | Day |
Last modified on
| 2020 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045369
