UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036706 |
|---|---|
| Receipt number | R000041821 |
| Scientific Title | Immune checkpoint inhibitor versus chemotherapy for elderly non-small cell lung cancer:a meta-analysis |
| Date of disclosure of the study information | 2019/05/13 |
| Last modified on | 2019/05/10 13:14:13 |
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Basic information
Public title
Immune checkpoint inhibitor versus chemotherapy for elderly non-small cell lung cancer:a meta-analysis
Acronym
ICI for elderly NSCLC
Scientific Title
Immune checkpoint inhibitor versus chemotherapy for elderly non-small cell lung cancer:a meta-analysis
Scientific Title:Acronym
ICI for elderly NSCLC
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of immune checkpoint inhibitors and chemotherapy for NSCLC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival(OS)
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with non-small cell lung cancer aged 65 years or older
Key exclusion criteria
patients with non-small cell lung cancer aged less than 65 years.
Target sample size
1000
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
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, 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
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan
TEL
+81-3-3784-8532
Homepage URL
koichi-a@med.showa-u.ac.jp
Sponsor or person
Institute
Department of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine, Division of Respiratory Medicine and Allergology, 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
Department of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan
Tel
+81-3-3784-8532
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
| 2019 | Year | 05 | Month | 13 | 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
1920
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
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
BACKGROUND:The details of the efficacy and safety profile of the Immune checkpoint inhibitor [ICI] against elderly non-small cell lung cancer [NSCLC] have not been fully elucidated. Objective: To compare the efficacy for elderly people with NSCLC in ICI group and chemotherapy group. Methods:A meta-analysis of randomized controlled trials was conducted. The primary endpoint was overall survival [OS] in the age group over 65 years. Results Six trials [n = 1920] were included in this analysis. OS was significantly better in the ICI group compared to the chemotherapy group (hazard ratio [HR], 0.70; 95% CI, 0.60 to 0.81). In the subgroup analysis by drug, each of the nivolumab, pembrolizumab, and atezolizumab groups was significantly better than the chemotherapy group (HR [95% CI] = 0.68 [0.51 to 0.92], 0.69 [0.51 to 0.93]. , 0.66 [0.52 to 0.83]). By treatment history, no significant difference was shown between the ICI group and the chemotherapy group in the first line group, but was significantly better in the ICI group compared to the chemotherapy group in the previously treated treated group (HR [95 [95] % CI] = 0.69 [0.59 to 0.81]). Subgroup analysis by PD-L1 expression rate showed that ICI group was significantly better than chemotherapeutic group in each group with expression rate of 1% or more and 50% or more (HR [95% CI] = 0.69 [0.51 to 0.93], 0.45 [0.29 to 0.70]). Conclusion: The effectiveness of ICI for elderly NSCLC was shown. Further clinical studies to validate the more detailed efficacy and safety profile of ICI for elderly NSCLC are desired.
Management information
Registered date
| 2019 | Year | 05 | Month | 10 | Day |
Last modified on
| 2019 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041821
