UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study of biomarkers predicting response to nivolumab in non-small-cell lung cancer
Acronym	Study of biomarkers predicting response to nivolumab in NSCLC
Scientific Title	Exploratory study of biomarkers predicting response to nivolumab in non-small-cell lung cancer
Scientific Title:Acronym	Study of biomarkers predicting response to nivolumab in 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 explore biomarkers that can predict the efficacy of nivolumab in patients with NSCLC, PD-L1 and PD-L2 gene copy numbers in tumor cells, serum levels of soluble PD-L1, and profiles of leukocytes in patients treated with nivolumab are evaluated.
Basic objectives2	Others
Basic objectives -Others	Exploration of predictors for efficacy in nivolumab therapy
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Association of the response rate of nivolumab therapy with tumor PD-L1 and/or PD-L2 copy number alterations, PD-L1 and/or PD-L2 protein expression, serum levels of soluble PD-L1, and profiles of leukocytes.
Key secondary outcomes	Association of progression-free survival and overall survival of nivolumab therapy with tumor PD-L1 and/or PD-L2 copy number alterations, PD-L1 and/or PD-L2 protein expression, serum levels of soluble PD-L1, and profiles of leukocytes.

Base
Study type	Observational

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Receiving nivolumab therapy 2. Histologically proven advanced or recurrent NSCLC 3. Chemotherapy pre-treated 4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2 5. Adequate specimens available for FISH and IHC analyses 6. Life expectancy of more than 3 months 7. Aged equal to or greater than 18 years old 8. Written informed concent
Key exclusion criteria	1. Combined autoimmune disease or history of recurrent autoimmune disease 2. Interstitial lung disease 3. Severe medical comorbidities 4. Uncontrolled brain metastases
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Takafumi Middle name Last name Suda
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code	433125
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Inoue
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code	431-3125
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan
TEL	053-435-2263
Homepage URL
Email	yusukeinoue0421@yahoo.co.jp

Sponsor
Institute	Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Ono Pharmaceutical Co., Ltd. Bristol-Myers Squibb
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan
Tel	053-435-2111
Email	rinri@hama-med.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	2016 Year 06 Month 30 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	200
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	2016 Year 03 Month 01 Day
Date of IRB	2016 Year 06 Month 02 Day
Anticipated trial start date	2016 Year 06 Month 30 Day
Last follow-up date	2019 Year 12 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	PD-L1 protein expression on NSCLC tumor cells has limited power to predict the effcicacy of nivolumab. Thus the objective of this research is to explore biomarkers that can predict the effectiveness of nivolumab in patients with NSCLC. PD-L1 and PD-L2 gene copy numbers in tissue samples, serum levels of soluble PD-L1, and profiles of leukocytes in pheripheral blood are evaluated.

Management information
Registered date	2016 Year 05 Month 27 Day
Last modified on	2020 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025941