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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028561
Receipt No. R000032567
Scientific Title A phase II study of Nivolumab re-challenge therapy in patients with advanced non-small cell lung cancer who responded to prior PD-1/L1 inhibitors (WJOG9616L)
Date of disclosure of the study information 2017/08/08
Last modified on 2019/01/25

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Basic information
Public title A phase II study of Nivolumab re-challenge therapy in patients with advanced non-small cell lung cancer who responded to prior PD-1/L1 inhibitors (WJOG9616L)
Acronym Nivolumab re-challenge study (WJOG9616L)
Scientific Title A phase II study of Nivolumab re-challenge therapy in patients with advanced non-small cell lung cancer who responded to prior PD-1/L1 inhibitors (WJOG9616L)
Scientific Title:Acronym Nivolumab re-challenge study (WJOG9616L)
Region
Japan

Condition
Condition Pre-treated lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of nivolumab in NSCLC patients those who were benefit from prior PD-1/L1 inhibitors.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes To evaluate the efficacy of nivolumab in NSCLC patients those who were benefit from prior PD-1/L1 inhibitors.
Key secondary outcomes Disease control rate, progression-free survival, overall survival, safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Nivolumab 240mg/body, every 2 weeks
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Pathologically proven NSCLC
2. Clinical stage IIIB, C, IV, or post-operative relapse based on the classification of Lung Cancer ver8
3. Without symptomatic brain metastasis
4. With targetable lesion based on RECIST ver1.1
5. Those who were benefit from PD-1/L1 monotherapy such as CR, PR, SD lasting more than 6 months
6. ECOG PS of 0-1
Key exclusion criteria 1. Prior history of serious immune related adverse event
2. With active auto-immune disease
3. With interstitial lung disease confirmed by chest CT
4. Those receive steroid therapy more than prednisolone more than 10mg/day
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Teraoka
Organization Wakayama Medical Univercity
Division name Respiratory Medicine and Clinical Oncology
Zip code
Address 811-1, Kimiidera, Wakayama-city
TEL 073-447-2300
Email teraoka@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization Ono Pharmatheutical co.Bristol Meiyers 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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTs051180019
Org. issuing International ID_1 Ministry of Health, Labour and Welfare
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 08 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
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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 07 Day
Last modified on
2019 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032567

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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