UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036706
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email koichi-a@med.showa-u.ac.jp

Sponsor
Institute Department of Medicine, Division of Respiratory Medicine and Allergology, Showa University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041821

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.