UMIN-CTR Clinical Trial

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
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	142-8666
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan
TEL	+81337848532
Homepage URL
Email	koichi-a@med.showa-u.ac.jp

Sponsor
Institute	Showa University School of Medicine
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045369