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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026730
Receipt No. R000030688
Scientific Title Usefulness of FDG-PET/CT to predict the response after pembrolizumab in patients with PD-L1 positive advanced non-small cell lung cancer
Date of disclosure of the study information 2017/03/30
Last modified on 2017/03/28

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Basic information
Public title Usefulness of FDG-PET/CT to predict the response after pembrolizumab in patients with PD-L1 positive advanced non-small cell lung cancer
Acronym FDG-PET/CT and prediction of pembrolizumab in lung cancer
Scientific Title Usefulness of FDG-PET/CT to predict the response after pembrolizumab in patients with PD-L1 positive advanced non-small cell lung cancer
Scientific Title:Acronym FDG-PET/CT and prediction of pembrolizumab in lung cancer
Region
Japan

Condition
Condition advanced non-small cell lung cancer
Classification by specialty
Pneumology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Pembrolizumab, a programmed death 1 immune checkpoint inhibitor antibody, was effective for patients with PD-L1 positive advanced NSCLC. However, the presence of promising biomarker still remains unclear. Little is known about the role of CT scan as an appropriate radiological modality. Therefore, we conducted the clinical study to evaluate FDG-PET as a predictor of pembrolizumab.
Basic objectives2 Others
Basic objectives -Others To monitor the outcome after treatment
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changeing of SUVmax, MTV and TLG, and the efficacy of pembrolizumab

Evaluation after 1 month from administration of pembrolizumab
Key secondary outcomes Survival and adverse events

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 All patients undergo FDG-PET/CT before and 4 weeks after initiation of pembrolizumab therapy.
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 confirmed advanced non-small cell lung cancer (NSCLC), and PD-L1 positive advanced NSCLC
2) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
3) Patient with evaluable lesion based on RECIST
4) Written informed consent
Key exclusion criteria 1) Pregnant woman
2) Patients with obvious interstitial pneumonia or pulmonary fibrosis in the chest X-ray.
3) Patients with collagen vascular disease or autoimmune diseases
4) Other cases attending physician it is determined unsuitable for registration of the study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyochi Kaira
Organization Gunma University
Division name Oncology Clinical Development
Zip code
Address showa-machi, Meabasshi, Gunm , Japan
TEL 027-220-8222
Email kkaira1970@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyochi Kaira
Organization Gunma University
Division name Oncology Clinical Development
Zip code
Address showa-machi, Meabasshi, Gunm , Japan
TEL 027-220-8222
Homepage URL
Email kkaira1970@yahoo.co.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

Funding Source
Organization Gunma University Hospital
Organization
Division
Category of Funding Organization Self funding
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 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
2017 Year 03 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
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
Date of protocol fixation
2017 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 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 03 Month 28 Day
Last modified on
2017 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030688

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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