UMIN-CTR Clinical Trial

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
Last 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
1st 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