UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of pembrolizumab as first-line treatment in non-small cell lung cancer patients with poor performance status: a pilot study.
Acronym	A pilot study of pembrolizumab as first-line treatment in non-small cell lung cancer patients with poor performance status
Scientific Title	Safety and efficacy of pembrolizumab as first-line treatment in non-small cell lung cancer patients with poor performance status: a pilot study.
Scientific Title:Acronym	A pilot study of pembrolizumab as first-line treatment in non-small cell lung cancer 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 explore the efficacy of pembrolizumab as first-line therapy in non-small cell lung cancer patients with poor performance status
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression Free Survival
Key secondary outcomes	Objective Response Rate Disease Control Rate Overall survival QOL

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 200mg every 3 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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)ECOG PS 2 or 3 2)Non-small cell lung cancer 3)Stage IIIB or IV or recurrence 4)PD-L1 tumor proportion score of 50% or greater 5)No sensitizing EGFR mutations or ALK translocations 6)Chemotherapy naive 7)Provided written informed consent 8)With adequate organ function
Key exclusion criteria	1)Pleural effusion, ascites or pericardial effusion requiring drainage 2)Other cancers 3)Symptomatic brain metastasis and meningitis 4)With severe complication 5)Interstitial pneumonia on CT 6)Severe drug allergy 7)Active autoimmune disease that has required systemic treatment 8)Dementia 9)Other conditions not suitable for this study
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Noboru Hattori
Organization	Hiroshima University Hospital
Division name	Department of Respiratory Internal medicine
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5196
Email	nhattori@hiroshima-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Takeshi Masuda
Organization	Hiroshima University
Division name	Department of Respiratory Internal medicine, Hiroshima Univestity Hospital
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5196
Homepage URL
Email	ta-masuda@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital
Institute
Department

Funding Source
Organization	none
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	広島大学病院

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 18 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	Terminated
Date of protocol fixation	2017 Year 07 Month 20 Day
Date of IRB	2017 Year 10 Month 04 Day
Anticipated trial start date	2017 Year 10 Month 18 Day
Last follow-up date	2019 Year 02 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 17 Day
Last modified on	2019 Year 05 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033815