UMIN-CTR Clinical Trial

Basic information
Public title	Pembrolizumab as first-line therapy in poor performance status patients with advanced non-small-cell lung cancer highly expressing PD-L1: an open-label, single arm, multicenter, phase II study
Acronym	Pembrolizumab in poor performance status patients
Scientific Title	Pembrolizumab as first-line therapy in poor performance status patients with advanced non-small-cell lung cancer highly expressing PD-L1: an open-label, single arm, multicenter, phase II study
Scientific Title:Acronym	Pembrolizumab in poor performance status patients
Region	Japan

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

Objectives
Narrative objectives1	efficacy of pembrolizumab in patients with NSCLC expressing high PD-L1
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	objective response rate
Key secondary outcomes	progression free survival overall survival safety quality of life explore possible biomarkers

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	treatment with 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) age of 20 years or older 2) histologically or cytologically proven non-small cell cancer 3) stage IV, incurable stage IIIB/C, or postoperative recurrent disease 4) treatment naive for lung cancer 5) PD-L1 (TPS = or > 50%) 6) without EGFR mutation or ALK fusion 7) without ROS1 fusion or unknown 8) an Eastern Cooperative Oncology Group performance status of 2 to 3 9) presence of a measurable lesion (RECIST ver. 1.1) 10) without uncontrolled severe comorbidities including pleural effusion, ascites and pericardial effusion, SVC symdrome, or spinal cord compression 11) without a history of palliative radiation therapy within 7 days of registration 12) adequate organ function 13) written informed consent
Key exclusion criteria	1) comordity of auto-immune disease 2) history of organ transplantation 3) symptomatic brain metastasis (patients with stable condition for more than 7days after radiation will be allowed.) 4) carcinomatous meningitis 5) presence of other cancer within 2 years of registration 6) presence of severe comordity
Target sample size	14

Research contact person
Name of lead principal investigator	1st name Katsuyuki Middle name Last name Kiura
Organization	Okayama University Hospital
Division name	Allergy and respiratory medicine
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL	086-235-7227
Email	kkiura@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Eiki Middle name Last name Ichihara
Organization	Okayama University Hospital
Division name	Allergy and respiratory medicine
Zip code	700-8558
Address	+81-86-235-7227
TEL	086-235-7227
Homepage URL
Email	ichiha-e@md.okayama-u.ac.jp

Sponsor
Institute	Department of allergy and respiratory medicine Okayama University Hospital
Institute
Department

Funding Source
Organization	Department of allergy and respiratory medicine Okayama University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Okayama University Hospital Ethics Comittee
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel	086-235-6938
Email	mae6605@adm.okayama-u.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	2018 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	14
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	Main results already published
Date of protocol fixation	2017 Year 11 Month 28 Day
Date of IRB	2018 Year 02 Month 20 Day
Anticipated trial start date	2018 Year 01 Month 17 Day
Last follow-up date	2023 Year 09 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 23 Day
Last modified on	2022 Year 07 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034447