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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034757
Receipt No. R000039638
Official scientific title of the study Phase II trial of pembrolizumab as first-line therapy for advanced non-small cell lung cancer with high PD-L1 expression in patients with poor performance status 1801.
Date of disclosure of the study information 2018/11/03
Last modified on 2018/11/03

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Basic information
Official scientific title of the study Phase II trial of pembrolizumab as first-line therapy for advanced non-small cell lung cancer with high PD-L1 expression in patients with poor performance status 1801.
Title of the study (Brief title) Pembrolizumab for NSCLC with high PD-L1 in patients with poor performance status
Region
Japan

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

Objectives
Narrative objectives1 To investigate the efficacy of pembrolizumab as first line therapy in poor performance status patients with PD-L1 highly expressed NSCLC
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ORR
Key secondary outcomes DCR,PFS, OS, safety etc.

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 pembrolizumab
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) Histologically or cytologically confirmed non-small cell lung cancer
2) Non curable stage IIIB/IIIc/IV
3) No prior systematic therapy[
4) PD-L1 50% or more
5) Without EGFR/ALK mutation
6) Without ROS1 fusion or unknown status
7) ECOG PS 2 or 3
8) With measurable lesion
9) Without uncontrollable pericardial effusion/pleural effusion/ascites/SVC syndrome/spinal compression
10) No palliative RT within 7 days of the registration
11) Adequate organ function
12) Written informed consent
Key exclusion criteria 1) With auto-immune disease
2) Received organ transplantation
3) With symptomatic brain metastasis
4) History of malignancy within 2 years of the registration
6) With severe complications such as IP and uncontrolled DM
7) Sever drug allergic history
8) Pregnancy
9) Refusalto contraception
10) Judged not suitable for this study
Target sample size 14

Research contact person
Name of lead principal investigator Katsuyuki Kiura
Organization Okayama University Hospital
Division name Allergy and Respiratory Medicine
Address 2-5-1, Shikata-cho, Okayama, 700-8558, Japan
TEL 086-235-7227
Email kkiura@md.okayama-u.ac.jp

Public contact
Name of contact person Eiki Ichihara
Organization Okayama University Hospital
Division name Allergy and Respiratory Medicine
Address 2-5-1, Shikata-cho, Okayama, 700-8558, Japan
TEL 0862357227
Homepage URL
Email ichiha-e@md.okayama-u.ac.jp

Sponsor
Institute OLCSG
Institute
Department

Funding Source
Organization NA
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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
2018 Year 11 Month 03 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 01 Month 31 Day
Anticipated trial start date
2018 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 03 Day
Last modified on
2018 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039638

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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